Positioning for lumbar puncture in newborn infants

Abstract

Background

Lumbar puncture is a common invasive procedure performed in newborns for diagnostic and therapeutic purposes. Approximately one in two lumbar punctures fail, resulting in both short‐ and long‐term negative consequences for the clinical management of patients. The most common positions used to perform lumbar puncture are the lateral decubitus and sitting position, and each can impact the success rate and safety of the procedure. However, it is uncertain which position best improves patient outcomes.

Objectives

To assess the benefits and harms of the lateral decubitus, sitting, and prone positions for lumbar puncture in newborn infants.

Search methods

We used standard, extensive Cochrane search methods. The latest search date was 24 January 2023.

Selection criteria

We included randomized controlled trials (RCTs) and quasi‐RCTs involving newborn infants of postmenstrual age up to 46 weeks and 0 days, undergoing lumbar puncture for any indication, comparing different positions (i.e. lateral decubitus, sitting, and prone position) during the procedure.

Data collection and analysis

We used standard Cochrane methods. We used the fixed‐effect model with risk ratio (RR) and risk difference (RD) for dichotomous data and mean difference (MD) and standardized mean difference (SMD) for continuous data, with their 95% confidence intervals (CI). Our primary outcomes were successful lumbar puncture procedure at the first attempt; total number of lumbar puncture attempts; and episodes of bradycardia. We used GRADE to assess the certainty of evidence for each outcome.

Main results

We included five studies with 1476 participants.

Compared to sitting position: lateral decubitus position may result in little to no difference in successful lumbar puncture procedure at the first attempt (RR 0.93, 95% CI 0.85 to 1.02; RD −0.04, 95% CI −0.09 to 0.01; I² = 70% and 72% for RR and RD, respectively; 2 studies, 1249 infants, low‐certainty evidence). None of the studies reported the total number of lumbar puncture attempts. Lateral decubitus position likely increases episodes of bradycardia (RR 1.72, 95% CI 1.08 to 2.76; RD 0.03, 95% CI 0.00 to 0.05; number needed to treat for an additional harmful outcome (NNTH) = 33; I² = not applicable and 69% for RR and RD, respectively; 3 studies, 1279 infants, moderate‐certainty evidence) and oxygen desaturation (RR 2.10, 95% CI 1.42 to 3.08; RD 0.06, 95% CI 0.03 to 0.09; NNTH = 17; I² = not applicable and 96% for RR and RD, respectively; 2 studies, 1249 infants, moderate‐certainty evidence). The evidence is very uncertain regarding the effect of lateral decubitus position on time to perform the lumbar puncture (MD 2.00, 95% CI −4.98 to 8.98; I² = not applicable; 1 study, 20 infants, very low‐certainty evidence). Lateral decubitus position may result in little to no difference in the number of episodes of apnea during the procedure (RR not estimable; RD 0.00, 95% CI −0.03 to 0.03; I² = not applicable and 0% for RR and RD, respectively; 2 studies, 197 infants, low‐certainty evidence). No studies reported apnea defined as number of infants with one or more episodes during the procedure.

Compared to prone position: lateral decubitus position may reduce successful lumbar puncture procedure at first attempt (RR 0.75, 95% CI 0.63 to 0.90; RD −0.21, 95% CI −0.34 to −0.09; number needed to treat for an additional beneficial outcome = 5; I² = not applicable; 1 study, 171 infants, low‐certainty evidence). None of the studies reported the total number of lumbar puncture attempts or episodes of apnea. Pain intensity during and after the procedure was reported using a non‐validated pain scale. None of the studies comparing lateral decubitus versus prone position reported the other critical outcomes of this review.

Authors' conclusions

When compared to sitting position, lateral decubitus position may result in little to no difference in successful lumbar puncture procedure at first attempt. None of the included studies reported the total number of lumbar puncture attempts. Furthermore, infants in a lateral decubitus position likely experience more episodes of bradycardia and oxygen desaturation, and there may be little to no difference in episodes of apnea. The evidence is very uncertain regarding time to perform lumbar puncture. Pain intensity during and after the procedure was reported using a pain scale that was not included in our prespecified tools for pain assessment due to its high risk of bias. Most study participants were term newborns, thereby limiting the applicability of these results to preterm babies.

When compared to prone position, lateral decubitus position may reduce successful lumbar puncture procedure at first attempt. Only one study reported on this comparison and did not evaluate adverse effects.

Further research exploring harms and benefits and the effect on patients' pain experience of different positions during lumbar puncture using validated pain scoring tool may increase the level of confidence in our conclusions.

Plain language summary

What are the risks and benefits of different positions for spinal taps in infants?

Key messages

• Spinal taps are often required in severe infections in newborns but may be difficult to perform, with approximately 50% of attempts ending in failure.

• We identified studies comparing three different body positions during spinal tap: lying sideways (lateral decubitus), sitting, and lying on the stomach (prone). In all positions the infants should keep their legs tucked in and neck bent forward (flexed).

• There may be little or no difference in first‐time success rates between sitting and lateral decubitus positions, and there may be a higher chance of success with prone position than with lateral decubitus position. There is likely a higher risk of adverse events with lateral decubitus than with sitting position.

What is a spinal tap?

A lumbar puncture, commonly known as a spinal tap, is a procedure that involves inserting a needle into the spine. Spinal taps may be done for many reasons and in all ages. They are often performed in newborns when searching for severe infections, including those affecting the brain and spine, to collect cerebrospinal fluid (the fluid that cushions the brain and spinal cord) or to insert medications. Because it involves inserting a needle, a spinal tap may cause pain and discomfort.

Various positions may be used to perform a spinal tap. The child may be lying sideways (lateral decubitus), sitting, or lying on their stomach (prone); in all positions they should keep their legs tucked in and neck bent forward (flexed).

What did we want to find out?

We wanted to find out whether in newborns different body positions may affect the chance of a successful spinal tap at the first attempt; the number of tries for a successful spinal tap; and the number of episodes of adverse events, such as slow heart rate, low oxygen levels in the blood, and apnea (episodes of not breathing). We also explored if there were any differences in the time taken to perform the spinal tap; pain and discomfort during a spinal tap; need for pain medication or sedation to perform a spinal tap; bleeding and bruising from spinal taps; and rate of infections related to spinal taps.

What did we do?

We searched for studies comparing different body positions while performing a spinal tap in newborns. We compared and summarized the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes.

What did we find?

We found five studies involving 1476 infants undergoing spinal taps. Only one study, with 171 infants, examined infants in prone position; the other studies compared children in lateral decubitus position and sitting. Four studies examined infants undergoing regular spinal taps, while one study examined spinal anesthesia in infants undergoing surgery. The smallest trial had 26 participants, while the largest had 1082. The studies included infants aged approximately five hours to five weeks, with average gestational ages (time since the mother's last menstrual period) from 31 to 41 weeks. The studies included 864 boys, 580 girls, and 32 with unspecified sex. Two trials were conducted in the USA, and one each in Spain, China, and the UK. One study received public funding, while the other four studies did not identify their funding sources.

We found no studies reporting the total number of spinal tap attempts or the number of infants experiencing apnea for either comparison. We found no studies reporting episodes of slow heart rate, low blood oxygen levels, time to perform the spinal tap, or episodes of breathing stops for a short period of time for the comparison of lateral decubitus position versus prone position.

When comparing performing spinal taps in infants in lateral decubitus position and sitting, we found that there may be little or no difference in chance of success at the first attempt; there is likely a higher risk of slow heart rate and low blood oxygen levels with lateral decubitus position; there may be little or no difference in number of episodes of apnea; and we are uncertain whether one position is faster than the other.

When comparing performing spinal taps in infants in lateral decubitus position and in prone position, there may be a lower chance of success at the first attempt in infants in lateral decubitus position.

What are the limitations of the evidence?

Our confidence in our findings is limited because of the low number of studies examining each question for each comparison; moreover, some of the studies used methods likely to introduce errors in their results. In some studies, the investigators may have been aware of which position was used. Furthermore, none of the studies provided data on all the outcomes we aimed to explore, and the differences reported between groups were often quite small.

How up‐to‐date is this evidence?

The evidence is current to January 2023.

Summary of findings

Summary of findings 1. Lateral decubitus position compared to sitting position for lumbar puncture in newborn infants.

Lateral decubitus position compared to sitting position for lumbar puncture in newborn infants
Patient or population: lumbar puncture in newborn infants Setting: neonatal units Intervention: lateral position Comparison: sitting position
Outcomes	Relative effect (95% CI)	Anticipated absolute effects* (95% CI)			Certainty of the evidence (GRADE)	What happens
		With sitting position	With lateral position	Difference
Successful lumbar puncture procedure at the first attempt, with < 500 red blood cells/mm3 № of participants: 1249 (2 RCTs)	RR 0.93 (0.85 to 1.02) RD −0.04 (−0.09 to 0.01)	Study population			⊕⊕⊝⊝ Low 1 2	Lateral decubitus position may result in little to no difference in successful lumbar puncture procedure at the first attempt, with < 500 red blood cells/mm3 compared to sitting position.
		62.0%	57.6% (52.7 to 63.2)	4.3% fewer (9.3 fewer to 1.2 more)
Total number of lumbar puncture attempts—not reported	‐	‐	‐	‐	‐	No studies reported this outcome.
Episodes of bradycardia № of participants: 1279 (3 RCTs)	RR 1.72 (1.08 to 2.76) RD 0.03, (0.00 to 0.05) NNTH = 33	Study population			⊕⊕⊕⊝ Moderate 3	Lateral decubitus position likely increases episodes of bradycardia compared to sitting position.
		4.0%	6.9% (4.3 to 11.1)	2.9% more (0.3 more to 7.1 more)
Time to perform the lumbar puncture № of participants: 20 (1 RCT)	‐	The mean time to perform the lumbar puncture without lateral decubitus position was 0.	‐	MD 2 higher (4.98 lower to 8.98 higher)	⊕⊝⊝⊝ Very low 3 4	The evidence is very uncertain about the effect of lateral decubitus position on time to perform the lumbar puncture compared to sitting position.
Episodes of desaturation (decrease of SpO2 to less than 80%) № of participants: 1249 (2 RCTs)	RR 2.10 (1.42 to 3.08) RD 0.06 (0.03 to 0.09) NNTH = 17	Study population			⊕⊕⊕⊝ Moderate 3	Lateral decubitus position likely increases episodes of desaturation (decrease of SpO2 to less than 80%) compared to sitting position.
		5.5%	11.6% (7.9 to 17.1)	6.1% more (2.3 more to 11.5 more)
Apnea: number of episodes (interruption of breathing for more than 20 seconds) during the procedure № of participants: 197 (2 RCTs)	RR not estimable RD 0.00 (−0.03 to 0.03)	Study population			⊕⊕⊝⊝ Low 3 5	Lateral decubitus position may result in little to no difference in apnea: number of episodes (interruption of breathing for more than 20 seconds) during the procedure compared to sitting position.
		No events among the 100 newborn infants	No events among the 97 newborn infants	0% more (3 less to 3 more)
Apnea: number of infants with 1 or more episodes (defined as interruption of breathing for more than 20 seconds) during the procedure—not reported	‐	‐	‐	‐	‐	No studies reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MD: mean difference; NNTH: number needed to treat for an additional harmful outcome; RCT: randomized controlled trial; RD: risk difference; RR: risk ratio; SpO2: arterial oxygen saturation
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

¹Downgraded one level for serious inconsistency: poor overlap of the CIs and high I².
²Downgraded one level for serious imprecision: CIs overlapping the no‐difference line.
³Downgraded one level for serious imprecision: wide CIs.
⁴Downgraded two levels for very serious study limitations: high and unclear risk of bias in multiple domains.
⁵Downgraded one level for serious study limitations: high and unclear risk of bias in multiple domains.

Summary of findings 2. Lateral decubitus position compared to prone position for lumbar puncture in newborn infants.

Lateral decubitus position compared to prone position for lumbar puncture in newborn infants
Patient or population: lumbar puncture in newborn infants Setting: neonatal units Intervention: lateral decubitus position Comparison: prone position
Outcomes	Relative effect (95% CI)	Anticipated absolute effects* (95% CI)			Certainty of the evidence (GRADE)	What happens
		With prone position	With lateral position	Difference
Successful lumbar puncture procedure at the first attempt, with < 500 red blood cells/mm3 № of participants: 171 (1 RCT)	RR 0.75 (0.63 to 0.90) RD −0.21 (−0.34 to −0.09) NNTB = 5	Study population			⊕⊕⊝⊝ Low 1 2	Lateral decubitus position may reduce successful lumbar puncture procedure at the first attempt, with < 500 red blood cells/mm3.
		85.4%	64.0% (53.8 to 76.8)	21.3% fewer (31.6 fewer to 8.5 fewer)
Total number of lumbar puncture attempts—not reported	‐	‐	‐	‐	‐	No studies reported this outcome.
Episodes of bradycardia, defined as a fall in heart rate of more than 30% below the baseline or less than 100 beats per minute for 10 seconds or longer— not reported	‐	‐	‐	‐	‐	No studies reported this outcome.
Time to perform the lumbar puncture—not reported	‐	‐	‐	‐	‐	No studies reported this outcome.
Episodes of desaturation, defined as a decrease of SpO2 to less than 80%, with no minimum duration specified—not reported	‐	‐	‐	‐	‐	No studies reported this outcome.
Apnea: number of episodes (defined as interruption of breathing for more than 20 seconds) during the procedure—not reported	‐	‐	‐	‐	‐	No studies reported this outcome.
Apnea: number of infants with 1 or more episodes (defined as interruption of breathing for more than 20 seconds) during the procedure—not reported	‐	‐	‐	‐	‐	No studies reported this outcome.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; NNTB: number needed to treat for an additional beneficial outcome; RCT: randomized controlled trial; RD: risk difference; RR: risk ratio; SpO2: arterial oxygen saturation
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

¹Downgraded one level for serious study limitations: high and unclear risk of bias in some domains.
²Downgraded one level for serious imprecision: wide CIs.

Background

Description of the condition

Lumbar puncture is a procedure to collect a small amount of the cerebrospinal fluid (CSF) that surrounds the brain and spinal cord, primarily for diagnostic purposes. The procedure is performed by inserting a needle into the subarachnoidal space of the spinal cord, usually through the fourth lumbar intervertebral space, and collecting CSF from it. A similar procedure may be performed to inject spinal medications such as analgesics, anesthetics, or antibiotics, or to remove CSF. The most common indication for lumbar puncture in newborns is suspected sepsis and meningitis, caused by microbes including group B Streptococcus (GBS), Escherichia coli, Listeriamonocytogenes, herpes simplex virus (HSV), and congenital syphilis. Other indications include seizures of unknown origin and suspected metabolic disease. The lumbar puncture results are essential for the choice and duration of treatment. However, lumbar puncture is a painful invasive procedure with a success rate of between 50% and 60% (Bedetti 2021; Neal 2017; Pinheiro 1993).

Description of the intervention

The most commonly used positions for lumbar puncture in newborns are the lateral decubitus and sitting position, while the use of the prone position has also been described. The position for lumbar puncture is not currently standardized and remains at the practitioner's discretion. It is unclear whether the success rate is dependent on the positioning of the infant (sitting versus lateral decubitus versus prone), timing of stylet removal (early versus late), or the experience of the practitioner. Some practitioners prefer to position a newborn in the lateral position as it appears to enable stability when holding the infant. Conversely, in the sitting position, the intervertebral space becomes wider, which may enable a higher success rate for lumbar puncture. However, the sitting position requires more effort to have a stable position for the infant during the procedure. The prone position is seldom used in neonates, even though it is considered to be the most comforting position for preterm newborns (Çakıcı 2020).

The safety and simplicity of lumbar puncture completion in newborns is needed in this age group, particularly considering the vulnerability of sick preterm infants. In adults, maximal hip flexion leads to a larger interspinal distance and facilitates the procedure (Sandoval 2004). To increase the interspinal space, the assistant maintains the newborn in the desired lumbar puncture position throughout the procedure while monitoring the baby's vital signs. Lumbar puncture is performed if there are no contraindications, including active bleeding, thrombocytopenia, severe cardio‐respiratory instability, uncontrollable seizures, signs of severe intracranial hypertension, and skin infection at the lumbar puncture site. Lumbar puncture is an aseptically performed procedure. The intervertebral space between the fourth lumbar vertebra (L4) and L5 is preferred (Barson 1970; Tubbs 2004). It has been shown that, even in neonates, Tuffier’s line, the transverse line connecting the tops of the iliac crests, is helpful to determine the point of needle insertion caudal to the termination of the spinal cord and at L4 to L5 intraspinal space in the neonate in the prone position, or at the upper edge of L5 in the laterally flexed position (Van Schoor 2014). A spinal needle with a stylet is slowly advanced into the fourth or fifth lumbar intervertebral space with a slight inclination toward the umbilicus for some millimeters until a fall in resistance is felt (Atlas of Procedures in Neonatology 2019). The stylet is then removed and the CSF is collected in vials. The choice of needle size for newborns ranges between 20 G and 25 G, with smaller needles possibly reducing the likelihood of a traumatic lumbar puncture (Flett 2020). There are also two different techniques for stylet removal: early, when the stylet is removed after advancing beyond the epidermis and dermis; and late, where the stylet is removed once the spinal needle enters the subarachnoid space.

How the intervention might work

There are pros and cons with each of the three positions – lateral decubitus, sitting, and prone (Öncel 2018). One of the main advantages of the lateral decubitus position is better control of the endotracheal tube in intubated neonates and perhaps easier identification of Tuffier's line (i.e. the horizontal line connecting the highest points of the iliac crests). The sitting position facilitates optimal visualization of the intervertebral spaces, for correct insertion of the needle. In intubated neonates it is difficult to control the endotracheal tube and maintain a stable sitting position, particularly if the assistant is inexperienced. Flexing the hips in both the sitting and the lateral decubitus positions may increase the interspinal space width. A study in 2013 evaluated the difference in interspinal width between lateral and sitting position in a population of preterm neonates with a weight < 2500 g (Öncel 2013). This difference was defined as the interspinal space in infants in the lateral decubitus with the body stretched the narrowest (3.18 mm) compared with the width of (3.445 mm) in a lateral flexed position. In sitting position the intraspinal space was found to be 3.86 mm without hip flexion, being as wide as 4.08 mm with hip flexion (Öncel 2013).

Similar results with wider interspinal spaces in sitting flexed position compared with lateral decubitus, with or without hip flexion, have been documented in a population of slightly older and larger neonates (Oulego‐Erroz 2014). However, flexion of the hip to obtain the maximum intraspinal space may be uncomfortable and stressful for the neonate, causing a struggle to maintain a stable position and thereby increasing the risk for lumbar puncture failure. Furthermore, passive flexion may lead to instability of vital signs and cardiorespiratory depression. The prone position seems to be the most physiological and comfortable for the neonate, and perhaps the easiest for the assistant holding the baby. The prone position has been demonstrated to provide the best comfort to newborns while promoting sleep at rest (Grunau 2004), and also gives a certain level of stress‐relief during procedures causing pain (Kahraman 2017). However, it may be difficult to perform the lumbar puncture in the prone position in neonates with higher body weight, due to difficulties in identifying the anatomical landmarks. In addition, prone positioning is uncommonly used by practitioners, with sitting or lateral decubitus routinely taught (Atlas of Procedures in Neonatology 2019).

Furthermore, it has been proposed that the timing of stylet removal may influence the success of the procedure (Baxter 2006). In early stylet removal, there is less risk of penetrating into the internal vertebral venous plexus space and attainment of blood, because of the immediate identification of CSF as the spinal needle enters the intraspinal space. However, if the stylet is removed too early, before passing through the dermis, there is a risk of introducing epidermal cells into the intraspinal space, leading to the formation of epidermoid tumors (Batnitzky 1977; Öncel 2018).

Independently of the position and stylet removal, the lumbar puncture procedure has several risks due to its invasive nature. It is often associated with some minor complications, such as localized pain and post‐lumbar puncture headache, which newborn infants may fail to express or which caregivers may have difficulty recognizing as newborns are non‐verbal. Major complications include infection, bleeding into the spinal canal, leakage of CSF, and very rarely damage to the spinal cord and cerebral herniation (Öncel 2018).

Why it is important to do this review

Approximately one in two lumbar puncture procedures fails (Bedetti 2021; Neal 2017; Pinheiro 1993). This can affect management including antibiotic duration and the type and duration of hospital stay. Moreover, it exposes the newborn to repetitive attempts to a painful procedure that may result in short‐ and long‐term consequences such as intraventricular hemorrhage or need for re‐intubation (Atlas of Procedures in Neonatology 2019; Walker 2019; Williams 2020). Hence, methods of maximizing the success rate of lumbar puncture should be explored. A separate Cochrane Review will assess the most effective pharmacological intervention for pain and discomfort management during lumbar puncture (Pessano 2023a).

Objectives

To assess the benefits and harms of the lateral decubitus, sitting, and prone positions for lumbar puncture in newborn infants.

Methods

Criteria for considering studies for this review

Types of studies

We included prospective randomized controlled trials (RCTs), quasi‐RCTs, cluster‐RCTs, and cross‐over RCTs.

Types of participants

We included preterm and term infants of postmenstrual age (PMA) up to 46 weeks and 0 days, irrespective of their gestational age at birth, undergoing lumbar puncture for any indication.

Types of interventions

• Lateral decubitus position compared to sitting position

• Lateral decubitus position compared to prone position

• Sitting position compared to prone position

Types of outcome measures

Outcome measures did not form part of the eligibility criteria.

Primary outcomes

• Successful lumbar puncture procedure at the first attempt, with < 500 red blood cells/mm³ (Greenberg 2008)

• Total number of lumbar puncture attempts

• Episodes of bradycardia, defined as a fall in heart rate of more than 30% below the baseline or less than 100 beats per minute for 10 seconds or longer

Secondary outcomes

• Time to perform the lumbar puncture

• Episodes of desaturation, defined as a decrease of arterial oxygen saturation (SpO₂) to less than 80%, with no minimum duration specified

• Apnea: number of episodes (defined as interruption of breathing for more than 20 seconds) during the procedure

• Apnea: number of infants with one or more episodes (defined as interruption of breathing for more than 20 seconds) during the procedure

• Need for pain/sedation medication to perform the lumbar puncture

• Skin changes at the lumbar puncture site, including bleeding and petechiae

• Infection rate related to the lumbar puncture

• Pain, assessed with the following scales:

  • ABC (Acuteness of the first cry, Burst rhythmicity and temporal Constancy of cry intensity) scale (Bellieni 2005), for both term and preterm infants;

  • Behavioral Indicators of Infant Pain (BIIP) (Holsti 2008), for preterm infants only;

  • Douleur Aiguë du Nouveau‐né (DAN) (Acute Pain in Newborn infants, APN, English version) (Carbajal 1997), for both term and preterm infants;

  • Neonatal Infant Pain Scale (NIPS) (Lawrence 1993), for both term and preterm infants;

  • Neonatal Pain, Agitation, and Sedation Scale (N‐PASS) (Hummel 2008), for both term and preterm infants;

  • Premature Infant Pain Profile (PIPP) /PIPP‐revised (PIPP‐R) (Gibbins 2014; Stevens 1996), for both term and preterm infants;

  • Neonatal Facial Coding System (NFCS) (Peters 2003), for both term and preterm infants; and

  • Face, Legs, Activity, Cry and Consolability (FLACC) (Merkel 1997), for term infants only.

• Parent satisfaction with care provided in the neonatal intensive care unit (NICU) (as measured by a validated instrument/tool) (Butt 2013)

If a study reported more than one pain scale among those listed above, we reported them separately. We planned to report the mean values of each pain scale assessed at the following time points.

• During the procedure

• Up to 10 minutes after the procedure

• Between 11 and 59 minutes after the procedure

• One to two hours after the procedure

If a study reported more than one time point among those listed above, we reported them all. We reported the worst score within each time frame.

Search methods for identification of studies

The Cochrane Sweden Information Specialist developed a draft search strategy for PubMed (National Library of Medicine) in consultation with the authors (Appendix 1). This strategy had been peer reviewed by an Information Specialist using the Peer Review of Electronic Search Strategies (PRESS) Checklist (McGowan 2016a; McGowan 2016b). We adapted the MEDLINE strategy for other databases, using appropriate syntax (Appendix 2).

We used population and methodological filters developed by Cochrane Neonatal. The RCT search filter for Ovid MEDLINE, as recommended by Cochrane Neonatal, was adapted to the syntax of PubMed (National Library of Medicine) and used to identify randomized and quasi‐randomized studies. Searches for eligible trials were conducted without language, publication year, publication type, or publication status restrictions.

Electronic searches

We searched the following databases:

• Cochrane Central Register of Controlled Trials (CENTRAL; 2023, Issue 1) via Wiley (24 January 2023);

• PubMed (National Library of Medicine) (1946 to 24 January 2023); and

• Embase.com (Elsevier) (1974 to 25 January 2023).

Searching other resources

We identified trial registration records using CENTRAL and by independent searches of:

• ISRCTN registry (www.isrctn.com);

• US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (clinicaltrials.gov); and

• World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (trialsearch.who.int/Default.aspx).

We screened the reference lists of included studies and related systematic reviews for studies not identified by the database searches.

We searched for errata or retractions of included studies published on PubMed (www.ncbi.nlm.nih.gov/pubmed).

Data collection and analysis

We collected information from each report on the methods of randomization, blinding, intervention, stratification, and whether the trial was single or multicenter. We recorded information related to trial participants including birthweight, gestational age, number of participants, indication for lumbar puncture, and position of the infant for the lumbar puncture procedure. We analyzed the clinical outcomes noted above in Types of outcome measures.

Selection of studies

We downloaded all titles and abstracts retrieved by the electronic searches to reference management software and removed any duplicates. We used Cochrane's Screen4Me to reduce screening activities by the review authors. Screen4Me comprises three components:

• known assessments (a service that matches records in the search results to records that have been screened by Cochrane Crowd and labeled as 'RCT' or 'not an RCT');

• the RCT classifier (a machine‐learning model that distinguishes RCTs from non‐RCTs);

• Cochrane Crowd (Cochrane’s crowdsourcing platform, where contributors from around the world help to identify randomized trials and other types of healthcare‐related research).

We added any references rejected as not‐RCTs by Screen4Me to the 'Irrelevant' segment of Covidence, and saved results in an RIS‐formatted text file suitable for import into bibliographic management or other software (Covidence). This approach means references are available for the purposes of deduplication when the review is updated, and for verification purposes should questions arise about the accuracy of Screen4Me categorization. We presented the results of Screen4Me in Figure 1 and incorporated the disposition of references in the PRISMA flow diagram (Figure 2) (Liberati 2009).

1.

Screen4Me summary diagram.

2.

PRISMA flow chart.

Two review authors (SP, MP) working independently screened the title/abstracts, then assessed the full text of references included after title/abstract review. At any point in the screening process, the two review authors (SP, MP) resolved disagreements by discussion or with a third review author (MB). We documented the reasons for excluding studies during full‐text review in a Characteristics of excluded studies table. We excluded a study if one or more PIC‐S (population, intervention, comparison, study design) elements were absent. Where a study omitted more than one PIC‐S element, we documented only one. We collated multiple reports of the same study so that each study, rather than each report, was the unit of interest in the review. We also described any available information about ongoing studies (Characteristics of ongoing studies) and studies awaiting classification (Characteristics of studies awaiting classification). We recorded the selection process in sufficient detail to complete a PRISMA flow diagram (Liberati 2009).

Data extraction and management

Two review authors (SP, MP) independently extracted data using a data extraction form integrated with a modified version of the Cochrane Effective Practice and Organisation of Care Group data collection checklist (Cochrane EPOC Group 2017). We piloted the form within the review team using a sample of included studies.

We extracted the following characteristics from each included study.

• Administrative details: study author(s); published or unpublished; year of publication; year in which study was conducted; presence of vested interest; details of other relevant papers cited.

• Study characteristics: study registration, study design type, study setting, number of study centers and location; informed consent; ethics approval, completeness of follow‐up (e.g. greater than 80%).

• Participants: number randomized, number lost to follow‐up/withdrawn, number analyzed, mean (and range) gestational age, mean (and range) chronological age, sex, severity of condition, diagnostic criteria, inclusion criteria and exclusion criteria.

• Interventions: characteristics of the position for the lumbar puncture.

• Outcomes as mentioned above under Types of outcome measures.

We resolved any disagreements by discussion.

We described ongoing studies identified by our search and documented available information such as the primary author, research question(s), methods, and outcome measures, together with an estimate of the reporting date, and reported them in the Characteristics of ongoing studies table.

If we had any queries or required more information, we contacted study authors for clarification. Two review authors (SP, MB) used Cochrane statistical software for data entry (RevMan Web 2023). We planned to replace any standard error of the mean (SEM) by the corresponding standard deviation (SD).

Assessment of risk of bias in included studies

Two review authors (SP, MP) independently assessed the risk of bias (low, high, or unclear) of all included trials using the Cochrane risk of bias tool for the following domains (Higgins 2017).

• Random sequence generation (selection bias)

• Allocation concealment (selection bias)

• Blinding of participants and personnel (performance bias)

• Blinding of outcome assessment (detection bias)

• Incomplete outcome data (attrition bias)

• Selective reporting (reporting bias)

• Any other bias

We resolved any disagreements by discussion or by consulting a third review author (MB). A more detailed description of risk of bias for each domain is provided in Appendix 3. We assessed the overall risk of bias according to three categories, as follows.

• Low risk of bias: we classified a trial as being at low risk of bias overall only if all domains were classified as being at low risk of bias.

• Unclear risk of bias: we classified a trial as being at unclear risk of bias overall if one or more domains were classified as being at unclear risk of bias, and no domain was at high risk of bias.

• High risk of bias: we classified a trial as being at high risk of bias overall if at least one domain was classified as being at high risk of bias.

Measures of treatment effect

Dichotomous data

For dichotomous data, we presented results using risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals (CIs). We calculated the number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH) with 95% CIs if there was a statistically significant RD.

Continuous data

For continuous data, we used mean differences (MDs) when outcomes were measured in the same way between trials. We used the standardized mean difference (SMD) to combine trials that measured the same outcome with different methods. Where trials reported continuous data as median and interquartile range (IQR), and data passed the test of skewness, we converted mean to median and estimated the SD as IQR/1.35.

If data from an RCT were not reported in a format that could be entered directly into a meta‐analysis, we converted them to the required format as recommended in Chapter 6 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2022a).

Unit of analysis issues

We performed the primary analysis per individual randomized.

For cluster‐randomized trials, we planned to extract information on the study design and unit of analysis for each study, indicating whether clustering of observations was present due to allocation to the intervention at the group level or clustering of individually randomized observations (e.g. infants within clinics). We planned to extract available statistical information needed to account for the implications of clustering on the estimation of outcome variances, such as design effects or intraclass correlation coefficients (ICCs), and whether the study adjusted the results for correlations in the data. In cases where the study did not account for clustering, we planned to do appropriate adjustments to the effective sample size following Cochrane guidance (Higgins 2022b). Where possible, we planned to derive the ICC for these adjustments from the trial itself, or from a similar trial. We planned that if an appropriate ICC was not available, we would conduct sensitivity analyses to investigate the potential effect of clustering by imputing a range of ICC values.

If a trial had multiple arms that were compared against the same control condition, and these arms would have been included in the same meta‐analysis, we would either combine groups to create a single pair‐wise comparison, or select one pair of interventions and exclude the others. We listed all treatment arms in the Characteristics of included studies table, even if they were not used in the review.

We planned to include only first‐phase data from cross‐over trials in the meta‐analysis and data synthesis.

We identified only five included studies, and there were no cluster‐randomized or cross‐over trials.

Dealing with missing data

Where feasible, we carried out an intention‐to‐treat (ITT) analysis for all outcomes, meaning we analyzed all participants in the treatment group to which they had been randomized, regardless of the actual treatment received. If we identified important missing data (in the outcomes) or unclear data, we attempted to contact the study authors for the missing information. We made explicit the assumptions of any methods used to deal with missing data. We planned to perform sensitivity analyses to assess how sensitive results were to reasonable changes in the undertaken assumptions; however, this was not necessary because we received explanations from the study authors. We planned to address the potential impact of missing data on the findings of the review in the Discussion section.

Assessment of heterogeneity

We described the clinical diversity and methodological variability of the evidence narratively and in tables. Tables included data on study characteristics such as design features, population characteristics, and intervention details.

To assess statistical heterogeneity, we visually inspected forest plots and described the direction and magnitude of effects and the degree of overlap between CIs. We used the I² statistic to quantify inconsistency among the trials in each analysis. We also considered the P value from the Chi² test to assess if heterogeneity was significant (P < 0.1). When we identified substantial heterogeneity, we reported the finding and explored possible explanatory factors using prespecified subgroup analysis.

We graded the degree of heterogeneity as follows:

• 0% to 40%: might not represent important heterogeneity;

• 30% to 60%: may represent moderate heterogeneity;

• 50% to 90%: may represent substantial heterogeneity;

• More than 75%: may represent considerable heterogeneity.

We used this rough guideline to interpret the I² value rather than a simple threshold, and our interpretation took into account that measures of heterogeneity (I² and Tau²) are very uncertain when the number of studies is small (Deeks 2022).

Assessment of reporting biases

We assessed reporting bias by comparing the stated primary and secondary outcomes and the reported outcomes. Where study protocols were available, we compared these to the full publications to determine the likelihood of reporting bias. In the Characteristics of included studies table, we described studies that used the interventions in a potentially eligible infant population but did not report any of our primary and secondary outcomes.

Had we identified more than 10 studies reporting a given outcome, we would have used funnel plots to screen for publication bias (Higgins 2022b). Had we found funnel plot asymmetry on visual assessment, we would have incorporated this in our assessment of certainty of the evidence (Egger 1997). Given that fewer than 10 studies were eligible for meta‐analysis, we are unable to rule out possible publication bias or small‐study effects.

Data synthesis

If we identified multiple studies that we considered sufficiently similar, we performed meta‐analysis using RevMan Web (RevMan Web 2023). For categorical outcomes, we calculated the typical estimates of RR and RD, each with its 95% CI; for continuous outcomes, we calculated the MD or SMD, each with its 95% CI. We used a fixed‐effect model to combine data where it was reasonable to assume that studies were estimating the same underlying treatment effect. If we judged meta‐analysis to be inappropriate, we analyzed and interpreted individual trials separately. If there was evidence of clinical heterogeneity, we tried to explain this based on the different study characteristics and subgroup analyses.

Subgroup analysis and investigation of heterogeneity

We have interpreted tests for subgroup differences in effects with caution given the potential for confounding with other study characteristics and the observational nature of the comparisons (see Section 10.11.2 of the Cochrane Handbook) (Deeks 2022). In particular, subgroup analyses with fewer than five studies per category are unlikely to be adequate to ascertain a valid difference in effects and have not been highlighted in our results. We planned that if subgroup comparisons were possible, we would conduct stratified meta‐analysis and a formal statistical test for interaction to examine subgroup differences that could account for effect heterogeneity (e.g. Cochran’s Q test, meta‐regression) (Borenstein 2013; Higgins 2022b).

Given the potential differences in the effects of interventions related to gestational age and birthweight, as discussed in the Background section, we planned to conduct subgroup comparisons to investigate whether interventions were more effective for the management of pain and discomfort during lumbar puncture in newborn infants.

We planned to carry out the following subgroup analyses of factors that might contribute to heterogeneity in the effects of the intervention.

• Prematurity: term; preterm

• Body weight: less than 1500 g; 1500 to 2500 g; more than 2500 g

• With or without intraventricular hemorrhage

• Timing of stylet removal: early; late

• Size and length of lumbar puncture needle

• Experience of the operator performing the lumbar puncture

We planned to use the main outcomes in subgroup analyses if we identified sufficient studies to support valid subgroup comparisons (at least five studies per subgroup).

Sensitivity analysis

We planned that if we identified substantial heterogeneity, we would conduct sensitivity analysis to determine whether the findings were affected by the inclusion of only those trials considered at low risk of selection, performance, and reporting bias. We planned to report the results of sensitivity analyses for our primary outcomes only.

As there is no formal statistical test for sensitivity analysis, we planned to provide informal comparisons between the different methods of estimating the effect under different assumptions. Changes in P values may not accurately reflect the difference between the main analysis and sensitivity analysis, since statistical significance may be lost with fewer studies.

We planned to report sensitivity analysis results in tables rather than in forest plots. However, we did not perform sensitivity analysis because of the small number of included studies for each comparison.

Summary of findings and assessment of the certainty of the evidence

We used the GRADE approach, as outlined in the GRADE Handbook (Schünemann 2013; Schünemann 2022), to assess the certainty of evidence for the following (clinically relevant) outcomes.

• Successful lumbar puncture procedure at the first attempt, with < 1 × 10⁹ red blood cells/L

• Total number of lumbar puncture attempts

• Episodes of bradycardia, defined as a fall in heart rate of more than 30% below the baseline or less than 100 beats per minute for 10 seconds or longer

• Time to perform the lumbar puncture

• Episodes of desaturation, defined as a decrease of arterial oxygen saturation (SpO₂) to less than 80%, with no minimum duration specified

• Apnea: number of episodes (defined as interruption of breathing for more than 20 seconds) during the procedure

• Apnea: number of infants with one or more episodes (defined as interruption of breathing for more than 20 seconds) during the procedure

Two review authors (MP, MB) independently assessed the certainty of the evidence for each of the outcomes above. We included a summary of findings table for each of the specified comparisons in Types of interventions; however, we did not create a summary of findings table for sitting versus prone position, as no studies were included in this comparison. We considered evidence from RCTs as high certainty, downgrading one level for serious (or two levels for very serious) limitations based upon the following: design (risk of bias), consistency across studies, directness of the evidence, precision of estimates, and presence of publication bias.

We used GRADEpro GDT software to create two summary of findings tables to report the certainty of the evidence for the following comparisons (GRADEpro GDT).

• Lateral decubitus position compared to sitting position (Table 1)

• Lateral decubitus position compared to prone position (Table 2)

The GRADE approach results in an assessment of the certainty of a body of evidence in one of the following four grades.

• High: we are very confident that the true effect lies close to that of the estimate of the effect.

• Moderate: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.

• Low: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.

• Very low: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

Results

Description of studies

For further details, see Characteristics of included studies; Characteristics of excluded studies; Characteristics of studies awaiting classification; Characteristics of ongoing studies.

Results of the search

The literature search conducted in January 2023 yielded a total of 2782 references (2723 after deduplication). These references were analyzed using Cochrane's Screen4Me (S4M) platform. S4M categorized 2107 references as non‐RCTs (Figure 1). The review authors screened the titles and abstracts of the remaining 616 references, of which 604 were excluded.

We evaluated 12 full texts, excluding five studies (Apiliogullari 2008; NCT02834156; NCT04070144; NCT04828746; Zhuang 2022), and including five studies in the review (see Figure 2) (Guo 2022; Hanson 2016; Marshall 2022; Vila 2002; Weisman 1983). We classified one study from a trial registry as ongoing (CTRI/2015/10/006280), and one study as awaiting classification (Hanson 2013).

Included studies

We included five studies with a total of 1476 participants.

Four of the five included trials were randomized (Guo 2022; Hanson 2016; Marshall 2022; Vila 2002), and one was quasi‐randomized (Weisman 1983); see Characteristics of included studies. We included no cross‐over or cluster‐randomized trials in the review. One study had a 2 x 2 factorial design, assessing also the effects of early versus late stylet removal (Marshall 2022). One study included an additional group where lumbar puncture (LP) was performed in a modified lateral position (on the left side, with hips flexed only 90 degrees, legs extended at the knees to prevent abdominal compression); we did not include this study arm in the review (Weisman 1983).

Two trials were conducted in the USA (Hanson 2016; Weisman 1983), and one each in China (Guo 2022), Spain (Vila 2002), and the UK (Marshall 2022). The five studies included 1476 newborn infants. The sample size ranged from 26 participants in the oldest study (Weisman 1983), to 1082 participants in the most recent study (Marshall 2022), that latter of which provides more than 70% of the total number of infants included in the review. In one study (Vila 2002), LP was performed to administer spinal anesthesia for inguinal herniotomy in preterm infants, whereas the indication was for diagnostic purposes in the other four studies. All studies except one, Weisman 1983, reported the sex of the infants by group. The mean gestational age of the infants in the included studies ranged from 31 weeks to 41 weeks, with the largest study enrolling only term newborns (Marshall 2022). One study reported only the chronological age of the participants and did not specify the gestational age (Hanson 2016). The mean postnatal age at procedure completion ranged from 4.9 hours to five weeks.

Interventions

Four studies compared lateral decubitus to sitting position (Hanson 2016; Marshall 2022; Vila 2002; Weisman 1983); one study compared lateral decubitus to prone position (Guo 2022); and no studies compared sitting to prone position.

In the standard lateral position the newborn was placed on one side with hips flexed to place knees to chest. In one of these studies a modified lateral position was also included, with hips flexed only 90 degrees and legs extended at the knees in order to prevent abdominal compression. In the sitting position the infant was held in a semi‐upright, sitting position. In all studies the neck was maintained in a neutral position, to avoid excessive flexion or extension.

Only one study explored the effects of a prone position during LP (Guo 2022). The neonate was kept in prone position with limbs flexed; a butterfly pillow could be placed under the body. The head was tilted to one side.

Ongoing studies

We identified one ongoing study, from India, including 236 newborn infants up to 30 days old (see CTRI/2015/10/006280; Characteristics of ongoing studies). This study has a 2 x 2 factorial design, investigating also the effects of EMLA, a topical anesthetic agent. Like most studies conducted so far, CTRI/2015/10/006280 compares lateral decubitus versus sitting position. The primary outcome is successful LP, defined as obtaining a non‐hemorrhagic CSF; secondary outcomes include heart rate, transcutaneous oxygen saturation and transcutaneous carbon dioxide, pain scores assessed as per PIPP score, adverse skin reaction (blanching, rashes, erythema, purpuric lesion at site of application), and the number of attempts completed for successful LP.

Studies awaiting classification

We identified one study awaiting classification because the full text of this conference abstract is not available (Hanson 2013).

Excluded studies

We excluded four studies because newborn infants were not included (NCT02834156; NCT04070144; Zhuang 2022), or were only a minor proportion of the randomized participants undergoing LP (Apiliogullari 2008; enrolled patients between one month and 12 years of age). One study compared LP with ultrasound versus without ultrasound, and not different positions (NCT04828746).

Risk of bias in included studies

The overall quality of the studies was limited (Figure 3; Figure 4). The included studies had one to three risk of bias domains at high risk of bias.

3.

Risk of bias graph.

4.

Risk of bias summary.

Details of the methodological quality of each study are described in the Characteristics of included studies table.

Allocation

We assessed random sequence generation to be adequate in two studies (Guo 2022; Marshall 2022) and unclear in two studies (Hanson 2016; Vila 2002). One study was quasi‐randomized (Weisman 1983), basing allocation on hospital admission number, resulting in high risk for both sequence generation and allocation concealment. Allocation of the randomization was properly concealed in one study (Marshall 2022). The other studies provided no information on allocation concealment (Guo 2022; Hanson 2016; Vila 2002).

Blinding

Due to the nature of the intervention, performance bias (blinding of participants and personnel) was high in all studies (Guo 2022; Hanson 2016; Marshall 2022; Vila 2002; Weisman 1983). Blinding of outcome assessors was unclear in three studies (Marshall 2022; Vila 2002; Weisman 1983). In two studies outcome assessors were aware of study allocation (Guo 2022; Hanson 2016), resulting in high risk of detection bias.

Incomplete outcome data

No information on dropouts or exclusions was provided in two studies, resulting in an unclear risk of attrition bias (Guo 2022; Weisman 1983). The other studies reported complete outcome data (Hanson 2016; Marshall 2022; Vila 2002).

Selective reporting

Reporting bias was unclear in four studies because the study protocol was not available (Guo 2022; Hanson 2016; Vila 2002; Weisman 1983). In one study all the specified outcomes had been reported (Marshall 2022), resulting in a judgment of low risk of bias.

Other potential sources of bias

We identified no other sources of bias in four studies (Guo 2022; Marshall 2022; Vila 2002; Weisman 1983). In one study (Hanson 2016), physicians were allowed to switch infants to a different position after the first attempt; both ITT and per‐protocol analysis were reported.

Effects of interventions

See: Table 1; Table 2

Lateral decubitus position compared to sitting position

Four studies were included in this comparison (Hanson 2016; Marshall 2022; Vila 2002; Weisman 1983). See Table 1.

Primary outcomes

Successful lumbar puncture procedure at the first attempt

Two studies reported this outcome (Hanson 2016; Marshall 2022). Lateral decubitus position may result in little to no difference in successful LP procedure at the first attempt compared with sitting position (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.85 to 1.02; RD (risk difference) −0.04, 95% CI −0.09 to 0.01; I² = 70% and 72% for RR and RD, respectively; 2 studies, 1249 infants, low‐certainty evidence; Analysis 1.1).

1.1. Analysis.

Comparison 1: Lateral decubitus position versus sitting position, Outcome 1: Successful lumbar puncture procedure at the first attempt, with < 500 red blood cells/mm³

Total number of lumbar puncture attempts

No studies reported this outcome.

Episodes of bradycardia

Three studies reported this outcome (Hanson 2016; Marshall 2022; Vila 2002). Lateral decubitus position likely increases episodes of bradycardia compared with sitting position (RR 1.72, 95% CI 1.08 to 2.76; RD 0.03, 95% CI 0.00 to 0.05; number needed to treat for an additional harmful outcome (NNTH) = 33; I² = not applicable and 69% for RR and RD, respectively; 3 studies, 1279 infants, moderate‐certainty evidence; Analysis 1.2).

1.2. Analysis.

Comparison 1: Lateral decubitus position versus sitting position, Outcome 2: Episodes of bradycardia

Secondary outcomes

Time to perform the lumbar puncture

One study reported this outcome (Weisman 1983). The evidence is very uncertain regarding the effect of lateral decubitus position on time to perform the LP compared with sitting position (mean difference 2.00, 95% CI −4.98 to 8.98; I² = not applicable; 1 study, 20 infants, very low‐certainty evidence; Analysis 1.3).

1.3. Analysis.

Comparison 1: Lateral decubitus position versus sitting position, Outcome 3: Time to perform the lumbar puncture

Episodes of desaturation

Two studies reported this outcome (Hanson 2016; Marshall 2022). Lateral decubitus position likely increases the number of episodes of desaturation (decrease of arterial oxygen saturation (SpO₂) to less than 80%) compared with sitting position (RR 2.10, 95% CI 1.42 to 3.08; RD 0.06, 95% CI 0.03 to 0.09; NNTH = 17; I² = not applicable and 96% for RR and RD, respectively; 2 studies, 1249 infants, moderate‐certainty evidence; Analysis 1.4).

1.4. Analysis.

Comparison 1: Lateral decubitus position versus sitting position, Outcome 4: Episodes of desaturation (decrease of SpO₂ to less than 80%)

Apnea: number of episodes during the procedure

Two studies reported this outcome (Hanson 2016; Marshall 2022). Lateral decubitus position may result in little to no difference in apnea: number of episodes (interruption of breathing for more than 20 seconds) during the procedure compared with sitting position (RR not estimable; RD 0.00, 95% CI −0.03 to 0.03; I² = not applicable and 0% for RR and RD, respectively; 2 studies, 197 infants, low‐certainty evidence; Analysis 1.5).

1.5. Analysis.

Comparison 1: Lateral decubitus position versus sitting position, Outcome 5: Apnea: number of episodes (interruption of breathing for more than 20 seconds) during the procedure

No studies reported apnea (defined as number of infants with one or more episodes during the procedure); need for pain/sedation medication to perform the LP; skin changes at the LP site; infection rate related to the LP; pain assessed with validated scales; or parent satisfaction with care provided in the NICU.

Lateral decubitus position compared to prone position

One study was included in this comparison (Guo 2022). See Table 2.

Primary outcomes

Successful lumbar puncture procedure at the first attempt

One study reported this outcome (Guo 2022). Lateral decubitus position may reduce successful LP procedure at the first attempt, with < 500 red blood cells/mm³ (RR 0.75, 95% CI 0.63 to 0.90; RD −0.21, 95% CI −0.34 to −0.09; number need to treat for an additional beneficial outcome = 5; I² = not applicable; 1 study, 171 infants, low‐certainty evidence; Analysis 2.1).

2.1. Analysis.

Comparison 2: Lateral decubitus position versus prone position, Outcome 1: Successful lumbar puncture procedure at the first attempt, with < 500 red blood cells/mm³

Total number of lumbar puncture attempts

No studies reported this outcome.

Episodes of bradycardia

No studies reported this outcome.

Secondary outcomes

No studies reported time to perform the LP; episodes of desaturation; apnea: number of episodes during the procedure; apnea: number of infants with one or more episodes during the procedure; need for pain/sedation medication to perform the LP; skin changes at the LP site; infection rate related to the LP; pain assessed with validated scales; parent satisfaction with care provided in the NICU.

Sitting position compared to prone position

No studies were included in this comparison.

Discussion

Summary of main results

We evaluated the benefits and harms of different positions used for LP in newborn infants. We included five studies with a total of 1476 newborns. Lateral decubitus position was compared to sitting position in four studies, and to prone position in one study. We did not find any studies comparing sitting to prone position.

Compared to sitting position, lateral decubitus position may result in little to no difference in successful LP procedure at the first attempt. None of the included studies reported the total number of LP attempts. Lateral decubitus position likely increases episodes of bradycardia and desaturation. Lateral decubitus position may result in little to no difference in the number of episodes of apnea during the procedure; no studies reported number of infants with one or more episodes of apnea. The evidence is very uncertain regarding the effect of lateral decubitus position on time to perform the LP compared with sitting position.

Compared to prone position, lateral decubitus position may reduce successful LP procedure at first attempt. Pain intensity during and after the procedure was reported using a pain scale that was not included in our prespecified tools for pain assessment due to its high risk of bias as reported in a recent review on scales validity (Giordano 2019). None of the studies comparing lateral decubitus versus prone position reported the other critical outcomes of this review.

We identified one ongoing study comparing lateral decubitus to sitting position (CTRI/2015/10/006280). Despite the protocol of this study having been published in 2015 (CTRI/2015/10/006280), results are not available yet.

Interventions

The expertise of the personnel performing LP was not always specified in the study methods and could have had an impact on the success of the procedure. However, in two of the studies it was clearly stated that procedures were standardized, and caregivers taking part in the trials had been specifically trained in order to reduce interpersonal variability in performing LP (Hanson 2016; Marshall 2022).

Only one study reported the use of topic anesthesia before the procedure (Marshall 2022). Even if the optimal pharmacological approach to perioperative analgesia during LP in newborns is still to be defined, being the topic of another Cochrane Review (Pessano 2023a), this may have influenced some of the outcomes evaluated in this review.

Condition requiring lumbar puncture

Four studies performed diagnostic LP on infants with different underlying conditions: sepsis, meningitis, maternal syphilis. Infants requiring CSF drainage were also included. In one study (Vila 2002), newborns received LP for spinal anesthesia before inguinal hernia repair intervention. The condition requiring LP can modify the baseline risk of the infant of developing adverse events. For example, neonates with sepsis usually have apnea and bradycardia as initial symptoms of the underlying disease. Moreover, LP for spinal anesthesia is generally performed by anesthesiologists and not by neonatologists, carrying a bias due to different skills and cultural background of the two medical specializations. The effect of the different conditions requiring LP on our comparisons was not explored.

Successful lumbar puncture procedure at the first attempt and total number of lumbar puncture attempts

For the outcome 'successful lumbar puncture procedure at the first attempt,' we chose the definition provided by Greenberg 2008 with a cutoff value for < 500 red blood cells/mm³. Three studies reported this outcome (Guo 2022; Hanson 2016; Marshall 2022), and one of them did not specify the criteria used to define a successful LP (Guo 2022), while the other two trials set the red blood cells cutoff at < 10,000 cells/mm³. We decided to use data from these studies because the data had already been used in previous trials, and the impact on the CSF white blood cell count has been noted to be small for red blood cell count of < 10,000 mm³ (Greenberg 2008).

Three studies reported total number of lumbar puncture attempts in different ways, thereby precluding meta‐analysis (Guo 2022; Marshall 2022; Vila 2002).

Episodes of bradycardia, desaturation, or apnea

Predefined criteria for these adverse events were not always available in the included studies, and when reported they were not always consistent with our definitions. In two of three studies reporting on bradycardia the definition was not provided (Hanson 2016; Vila 2002), while in the third study the cutoff of 100 beats per minute was the same as defined in our criteria, but the duration was not specified (Marshall 2022). Both the studies reporting on apnea episodes did not provide the definition of the events (Hanson 2016; Vila 2002). We found data on desaturation episodes in two trials, of which one was aligned with our definition (Marshall 2022), while the other trial did not specify the cutoff used to define these events (Hanson 2016). The inconsistency of the definitions of these adverse events can have an impact on the incidence reported.

Pain intensity and need for pain/sedation medication to perform the lumbar puncture

Despite LP being a painful procedure, only one of the included studies used pre‐procedural topical anesthesia (Marshall 2022), while the other studies did not mention either pharmacological or non‐pharmacological strategies for pain management during LP. In addition, pain intensity was evaluated as an outcome by only one trial (Guo 2022), which used a non‐validated scale.

Skin changes at the lumbar puncture site, including bleeding and petechiae, infection rate related to the lumbar puncture, and parent satisfaction with care provided in the NICU

None of these outcomes were reported in the five included studies, leading to a gap of knowledge on the topics. It is possible that a different position during LP can help keep the procedure rigorously sterile, or, vice versa, increase the risk of contamination, based on the interaction between operators, on the accessibility of the insertion point, and on the number of attempts required. Further studies are required to evaluate the impact of different positions used to perform LP on these outcomes.

Overall completeness and applicability of evidence

Population

Although we identified five studies, more than two‐thirds of the participants are from one recently published study (2022) including a large number of newborns undergoing LP (Marshall 2022). The population in this study includes term infants, while in the other four studies the participants' mean gestational age was < 37 weeks. Results could differ in preterm and term infants, due to their anatomical and physiological differences, and varying susceptibility to respiratory and circulatory issues in response to painful stimuli or positional changes. The effects of different positions to perform LP in different gestational age groups could not be explored because the majority of the included participants were term newborns. The conditions requiring LP differed in the included studies and may affect baseline risk of developing adverse events, though this effect was not examined further. The included studies were conducted in Europe, the USA, and Asia. We do not have data from the African population.

Intervention

The lateral decubitus position was quite standardized throughout the included studies, and in all studies the neck was kept in a neutral position, to avoid excessive flexion or extension. In one of the studies a modified lateral position was included, with hips flexed only 90 degrees and legs extended at the knees to prevent abdominal compression. We did not consider results from this group in our review (Weisman 1983). We have some concerns that the expertise of the personnel performing LP was not always specified in the study methods, which could impact on the success of the procedure. However, in two of the studies it was clearly stated that the procedures were standardized, and caregivers taking part in the trials had been specifically trained to reduce practitioner variability in performing LP (Hanson 2016; Marshall 2022). The effect of the different medical specialization and background of the personnel performing the procedure could not be explored.

Comparison

There is a knowledge gap regarding the effect of sitting versus prone position in performing lumbar puncture, as we found no studies reporting on this comparison. We found only one study reporting on prone versus lateral decubitus position (Guo 2022).

Outcomes

None of the studies reported pain (measured with one of our prespecified scales) during the procedure and need for pain medication, despite pain being an important topic in the care of newborns, especially in preterm patients. There was variability in the definitions used for adverse events such as bradycardia, apnea, and oxygen desaturation that could have impacted the results.

Quality of the evidence

For the comparison lateral decubitus versus sitting position for LP, we assessed the certainty of the evidence for critical outcomes as moderate to very low based on the GRADE approach (see Table 1). We downgraded the certainty of the evidence for successful lumbar puncture procedure at the first attempt one level for serious inconsistency due to poor overlap of the CIs and high I²,and one level for serious imprecision due to CIs overlapping the no‐difference line. We downgraded the certainty of the evidence for episodes of bradycardia and episodes of desaturation one level for serious imprecision due to wide CIs. We downgraded the certainty of the evidence for time to perform the LP for the same reason, and downgraded a further two levels for very serious study limitations due to high and unclear risk of bias in multiple domains. We downgraded the certainty of the evidence for number of episodes of apnea one level for serious imprecision due to wide CIs and one level for serious study limitations due to high and unclear risk of bias in multiple domains.

For the comparison lateral decubitus versus prone position for LP, the certainty of evidence was low for the only reported critical outcome (see Table 2). We downgraded one level for serious study limitations due to high and unclear risk of bias in some domains, and one level for serious imprecision due to wide CIs.

Potential biases in the review process

We succeeded in obtaining additional information from some study authors. Following full‐text screening, we excluded four studies because newborn infants were not included (NCT02834156; NCT04070144; Zhuang 2022), or were only a minor proportion of the randomized participants undergoing LP (Apiliogullari 2008); we excluded one additional study because ultrasound was used instead of different positions (NCT04828746). In one study the harms and benefits of early versus late stylet removal were also explored. As prespecified in the protocol (Types of participants) (Pessano 2023b), any indication for LP was included. Two studies explored time to perform the LP, but one of them used median and IQR and could only be reported narratively. The authors of this Cochrane Review were not involved in any of the included trials.

Agreements and disagreements with other studies or reviews

We have not found any previous systematic reviews exploring choice of positioning for LP in neonates. However, several clinical studies have been conducted comparing sitting position to lateral decubitus, in addition to the included clinical trials.

Previous ultrasound studies have suggested that there is no difference in subarachnoid space (Lo 2013), but an increase interspinous distance (Öncel 2013), in sitting position compared to lateral decubitus. This may indicate a higher chance of successful LP in sitting position, findings that were not demonstrated in our review. One study found fewer episodes of desaturation in sitting position compared to lateral decubitus (Gleason 1983), while another study recorded no episodes of adverse hypoxic events (Öncel 2013). This is largely consistent with our own findings, where lateral decubitus position likely results in more episodes of desaturation compared to sitting position, and it remains unknown if there is a difference in apneic episodes. Two previous studies did not find a difference in heart rate in different positions (Gleason 1983; Öncel 2013). This is inconsistent with our results, where lateral decubitus position likely results in more episodes of bradycardia compared to sitting position. Regarding prone position, no relevant previous literature was found.

Authors' conclusions

Implications for practice.

Lateral decubitus position compared to sitting position may result in little to no difference in successful lumbar puncture procedure at first attempt. None of the included studies reported the total number of lumbar puncture attempts. Lateral decubitus position likely increases episodes of bradycardia and desaturation, and may result in little to no difference in episodes of apnea. Pain intensity during and after the procedure was reported using a pain scale that was not included as one of our prespecified tools for pain assessment due to its high risk of bias as reported in a recent review on scales validity (Giordano 2019). The evidence for time to perform lumbar puncture was very uncertain. Most study participants were term newborns, raising concerns about the applicability of the results to preterm babies.

Lateral decubitus position compared to prone position may reduce successful lumbar puncture procedure at first attempt. Only one study reported on this comparison and did not assess adverse effects of the different positions. We did not find any studies comparing sitting to prone position.

Further research exploring the harms and benefits and the effect of different positions during lumbar puncture on patients' pain experience may add knowledge and increase confidence in these findings; it is likely valuable to assess pre‐procedure pain control and position together to determine the effect on lumbar puncture success.

Implications for research.

An ongoing study enrolling 236 newborn infants in India will compare lateral decubitus with sitting position, with or without use of topical anesthetic agent (EMLA). This study might contribute to improving the evidence base on lumbar puncture in newborn infants regarding optimal position and pharmacological management. The effects of the latter are assessed in a separate Cochrane Review (Pessano 2023a). Future studies should report outcome measures more consistently, including both benefits (such as successful lumbar puncture) and harms (episodes of bradycardia, desaturation, and apnea). Pain should be assessed with validated scales for procedural pain, based on the gestational age of the enrolled infants.

History

Protocol first published: Issue 1, 2023

Appendices

Appendix 1. Search strategy, protocol

Information specialist: Maria Björklund, Krister Aronsson

Affiliation: Lund University, Faculty of Medicine, Library & ICT, Sweden

PICO(s)

Population: term and preterm infants undergoing lumbar puncture

Interventions/Comparisons: lateral decubitus position vs sitting position vs prone position for lumbar puncture

Study design: only RCTs.

Search strategy

PubMed (National Library of Medicine)

Date of search: 23 August 2022

No publication date limitations or language limitations were used.

[Population‐ Cochrane Neonatal standard filter translated for PubMed neonatal.cochrane.org/Literature-Search-Filters-for-Neonatal-Reviews]

#1 ((("infant, newborn"[MeSH Terms]) OR ("intensive care, neonatal"[MeSH Terms])) OR ("intensive care units, neonatal"[MeSH Terms])) OR ("gestational age"[MeSH Terms])

707451 records

#2 babe[Text Word] OR babes[Text Word] OR baby*[Text Word] OR babies[Text Word] OR gestational age?[Text Word] OR infant?[Text Word] OR infantile[Text Word] OR infancy[Text Word] OR low birth weight[Text Word] OR low birthweight[Text Word] OR neonat*[Text Word] OR neo‐nat*[Text Word] OR newborn*[Text Word] OR new born?[Text Word] OR newly born[Text Word] OR premature[Text Word] OR pre‐mature[Text Word] OR pre‐matures[Text Word] OR prematures[Text Word] OR prematurity[Text Word] OR pre‐maturity[Text Word] OR preterm[Text Word] OR preterms[Text Word] OR pre term?[Text Word] OR preemie[Text Word] OR preemies[Text Word] OR premies[Text Word] OR premie[Text Word] OR VLBW[Text Word] OR VLBWI[Text Word] OR VLBW‐I[Text Word] OR VLBWs[Text Word] OR LBW[Text Word] OR LBWI[Text Word] OR LBWs[Text Word] OR ELBW[Text Word] OR ELBWI[Text Word] OR ELBWs[Text Word] OR NICU[Text Word] OR NICUs[Text Word]

1752818 records

#3 #1 OR #2

1752818 records

[Intervention]

#4 "spinal puncture"[MeSH Terms]

6648 records

#5 spinal puncture*[Text Word] OR lumbar puncture*[Text Word]

13489 records

#6 #4 OR #5

13489 records

#7 position*[Text Word] OR lateral[Text Word] OR decubitus[Text Word] OR sitting[Text Word] OR prone[Text Word] OR upright[Text Word] OR recumbent[Text Word] OR tilt*[Text Word]

1112417 records

[Study design filter‐ Cochrane Neonatal standard RCT filter https://neonatal.cochrane.org/Literature‐Search‐Filters‐for‐Neonatal‐Reviews]

#8 randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized [tiab] OR placebo [tiab] OR drug therapy [sh] OR randomly [tiab] OR trial [tiab] OR groups [tiab]

5512862 records

#9 quasirandom*[tw] or quasi‐random*[tw] or randomi*[tw] or randomly[tw]
1259395 records

#10 control*[tw] AND (group[tw] OR groups[tw] OR random[tw] OR trial[tw] OR trials[tw] OR study[tw])

3719557 records

#11 #8 OR #9 OR #10

7318910

#12 (animals [mh] NOT humans [mh])

5035843 records

#13 #11 NOT #12

6266105 records

[Combination search‐ population AND Intervention]

#3 AND #6 AND #7 AND #13

33 records

[Annotation: The search without the positioning block will retrieve approximately 680 records.]

Search report Cochrane Review

104 records

Appendix 2. Search strategy, full review

Information specialist: Maria Björklund, Krister Aronsson

Affiliation: Lund University, Faculty of Medicine, Library & ICT, Sweden

PICO(s)

Population: term and preterm infants undergoing lumbar puncture

Interventions/Comparisons:

lateral decubitus position vs sitting position vs prone position for lumbar puncture

Study design: only RCTs.

Search strategy

PubMed (National Library of Medicine)

Date of search: January 24, 2023

No publication date limitations or language limitations were used.

#1
((("infant, newborn"[MeSH Terms]) OR ("intensive care, neonatal"[MeSH Terms])) OR ("intensive care units, neonatal"[MeSH Terms])) OR ("gestational age"[MeSH Terms])
=715156 records
#2
babe[Text Word] OR babes[Text Word] OR baby*[Text Word] OR babies[Text Word] OR gestational age*[Text Word] OR infant*[Text Word] OR infantile[Text Word] OR infancy[Text Word] OR low birth weight[Text Word] OR low birthweight[Text Word] OR neonat*[Text Word] OR neo‐nat*[Text Word] OR newborn*[Text Word] OR new born*[Text Word] OR newly born[Text Word] OR premature[Text Word] OR premature[Text Word] OR pre‐matures[Text Word] OR prematures[Text Word] OR prematurity[Text Word] OR pre‐maturity[Text Word] OR preterm[Text Word] OR preterms[Text Word] OR pre term*[Text Word] OR preemie[Text Word] OR preemies[Text Word] OR premies[Text Word] OR premie[Text Word] OR VLBW[Text Word] OR VLBWI[Text Word] OR VLBW‐I[Text Word] OR VLBWs[Text Word] OR LBW[Text Word] OR LBWI[Text Word] OR LBWs[Text Word] OR ELBW[Text Word] OR ELBWI[Text Word] OR ELBWs[Text Word] OR NICU[Text Word] OR NICUs[Text Word]
=1813243 records

#3
#1 OR #2
=1812397 records

[Intervention]

#4
spinal puncture"[MeSH Terms]
=6704 records

#5
spinal puncture*[Text Word] OR lumbar puncture*[Text Word] OR spinal punction[Text Word] OR lumbar punction[Text Word] OR spinal tap[Text Word]
=14025 records

#6
#4 OR #5
=14025 records

#7
position*[Text Word] OR lateral[Text Word] OR decubitus[Text Word] OR sitting[Text Word] OR prone[Text Word] OR upright[Text Word] OR recumbent[Text Word] OR tilt*[Text Word]
=1137314 records

[Study design filter‐ Cochrane Neonatal standard RCT filter https://neonatal.cochrane.org/Literature‐Search‐Filters‐for‐Neonatal‐Reviews]

#8
randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized [tiab] OR placebo [tiab] OR drug therapy [sh] OR randomly[tiab] OR trial [tiab] OR groups [tiab]
=5639641 records

#9
quasirandom*[tw] or quasi‐random*[tw] or randomi*[tw] or randomly[tw]
=1291583 records

#10
control*[tw] AND (group[tw] OR groups[tw] OR random[tw] OR trial[tw] OR trials[tw] OR study[tw])
=3809660 records

#11
#8 OR #9 OR #10
=7491113 records

#12
(animals [mh] NOT humans [mh])
=5084053

#13
#11 NOT #12
=6422190 records

[Combination search‐ population AND Intervention]

#14
#3 AND #6 AND #7 AND #13
=35 records

Annotation: Additional terms for spinal puncture was added to the PubMed search and the other searches.

Embase.com (Elsevier, 1947‐present)

Date of search: January 25, 2023

No publication date limitations or language limitations were used.

[Population‐ Cochrane Neonatal standard filter translated for Embase https://neonatal.cochrane.org/Literature‐Search‐Filters‐for‐Neonatal‐Reviews ]

#1
('newborn'/de OR 'prematurity'/de OR 'newborn intensive care'/de OR 'newborn care'/de OR gestational) AND 'age'/de
=33368 records

#2
babe:ti,ab,kw OR babes:ti,ab,kw OR baby*:ti,ab,kw OR babies:ti,ab,kw OR 'gestational age*':ti,ab,kw OR infant$:ti,ab,kw OR infantile:ti,ab,kw OR infancy:ti,ab,kw OR 'low birth weight':ti,ab,kw OR 'low birthweight':ti,ab,kw OR neonat*:ti,ab,kw OR 'neo‐nat*':ti,ab,kw OR newborn*:ti,ab,kw OR 'new born*':ti,ab,kw OR 'newly born':ti,ab,kw OR premature:ti,ab,kw OR 'pre mature':ti,ab,kw OR 'pre matures':ti,ab,kw OR prematures:ti,ab,kw OR prematurity:ti,ab,kw OR 'pre maturity':ti,ab,kw OR preterm:ti,ab,kw OR preterms:ti,ab,kw OR ‘pre term$’:ti,ab,kw OR preemie:ti,ab,kw OR preemies:ti,ab,kw OR premies:ti,ab,kw OR premie:ti,ab,kw OR vlbw:ti,ab,kw OR vlbwi:ti,ab,kw OR 'vlbw i':ti,ab,kw OR vlbws:ti,ab,kw OR lbw:ti,ab,kw OR lbwi:ti,ab,kw OR lbws:ti,ab,kw OR elbw:ti,ab,kw OR elbwi:ti,ab,kw OR elbws:ti,ab,kw OR nicu:ti,ab,kw OR nicus:ti,ab,kw
=1287497

#3
#1 OR #2
=1304967 records

[Interventions]

#4
'lumbar puncture'/exp OR ('lumbar puncture':ti,ab,kw OR 'spinal puncture':ti,ab,kw OR 'lumbar punction':ti,ab,kw OR 'spinal punction':ti,ab,kw)
=34143 records

#5
position*:ti,ab,kw OR lateral:ti,ab,kw OR decubitus:ti,ab,kw OR sitting:ti,ab,kw OR prone:ti,ab,kw OR upright:ti,ab,kw OR recumbent:ti,ab,kw OR tilt*:ti,ab,kw
=1376043 records

Based on filter for Embase[Ovid]: [Study design filter‐ Cochrane Neonatal standard RCT filter https://neonatal.cochrane.org/Literature-Search-Filters-for-Neonatal-Reviews]

#6
'randomized controlled trial':it OR 'controlled clinical study':it OR random*:ti,ab,kw OR placebo:ti,ab,kw OR 'double blind procedure':ti,ab,kw OR randomization:ti,ab,kw OR quasirandom*:ti,ab,kw OR 'quasi random*':ti,ab,kw OR ((double:ti,ab,kw OR single:ti,ab,kw OR doubly:ti,ab,kw OR singly:ti,ab,kw) AND adj:ti,ab,kw AND (blind:ti,ab,kw OR blinded:ti,ab,kw OR blindly:ti,ab,kw)) OR ('controlled adj7':ti,ab,kw AND (study:ti,ab,kw OR design:ti,ab,kw OR trial:ti,ab,kw)) OR 'parallell group*':ab,ti OR 'cross over':ab,ti OR crossover:ab,ti OR 'open adj label':ab,ti OR ('control* adj2':ti,ab,kw AND (group?:ti,ab,kw OR random*:ti,ab,kw)) OR ((assign$:ab,ti OR match:ab,ti OR matched:ab,ti OR allocation:ab,ti) AND adj5:ab,ti AND (alternate:ab,ti OR group*1:ab,ti OR intervention*1:ab,ti OR patient*1:ab,ti OR subject*1:ab,ti OR participant*1:ab,ti)) 
=2046738 records
#7
((((((exp AND animals OR exp) AND invertebrate OR animal) AND experiment OR animal) AND model OR animal) AND tissue OR animal) AND cell OR nonhuman) AND ((human OR normal) AND human OR human) AND cell
=1785417 records
#8
(((((exp AND animals OR exp) AND invertebrate OR animal) AND experiment OR animal) AND model OR animal) AND tissue OR animal) AND cell OR nonhuman
=7919128 records
#9
#8 NOT #7
=6133711 records
#7 ‐ #9 Based on[Animal Exclusion‐https://community‐cochrane‐org/sites/default/files/uploads/inline‐files/Embase%20animal%20filter.pdf] för Embase[Ovid]
#10
#6 NOT #9
=1824141 records
[Combination search]

#11
#3 AND #4 AND #5 AND #10
=22 records

CENTRAL (via Cochrane Library, Issue 1 of 12, 2023)

Date of search: January 24, 2023

[Population]

#1 MeSH descriptor: [Infant, Newborn] explode all trees
17815 records

#2 MeSH descriptor: [Intensive Care, Neonatal] explode all trees

353 records

#3 MeSH descriptor: [Intensive Care Units, Neonatal] explode all trees

875 records

#4 MeSH descriptor: [Gestational Age] explode all trees

2796 records

#5 (babe OR babes OR baby* OR babies OR gestational age OR infant OR infantile OR infancy OR low birth weight OR low birthweight OR neonat* OR neo‐nat* OR newborn* OR new born OR newly born OR premature OR pre‐mature OR pre‐matures OR prematures OR prematurity OR pre‐maturity OR preterm OR preterms OR pre term OR preemie OR preemies OR premies OR premie OR VLBW OR VLBWI OR VLBW‐I OR VLBWs OR LBW OR LBWI OR LBWs OR ELBW OR ELBWI OR ELBWs OR NICU OR NICUs):ti,ab,kw

112958 records

#6 #1 OR #2 OR #3 OR #4 OR #5
1307675 records

[Intervention]

#7 MeSH descriptor: [Spinal Puncture] explode all trees

312 records

#8 (spinal puncture* OR lumbar puncture* OR spinal punction OR spinal tap):ti,ab,kw

2652 records

#9 #7 OR #8

2652 records

#10 (position* OR lateral OR decubitus OR sitting OR prone OR upright OR recumbent OR tilt*):ti,ab,kw

64260 records

#11 #6 AND #9 AND #10

466 records of which 455 are trials

CINAHLComplete (Cumulative Index to Nursing and Allied Health Literature; EbscoHost, inception to present)

Date of search: January 24, 2023

No publication date limitations or language limitations were used.

[Population]

#1 (MH "Infant, Newborn+")

158856 records

#2 (MH "Intensive Care, Neonatal+")
6538 records

#3 (MH "Intensive Care Units, Neonatal")

15800 records

#4 (MH "Gestational Age")

23422 records

#5 TX (babe OR babes OR baby* OR babies OR gestational age OR infant OR infantile OR infancy OR low birth weight OR low birthweight OR neonat* OR neo‐nat* OR newborn* OR new born OR newly born OR premature OR pre‐mature OR pre‐matures OR prematures OR prematurity OR pre‐maturity OR preterm OR preterms OR pre term OR preemie OR preemies OR premies OR premie OR VLBW OR VLBWI OR VLBW‐I OR VLBWs OR LBW OR LBWI OR LBWs OR ELBW OR ELBWI OR ELBWs OR NICU OR NICUs)

1022541 records

#6 #1 OR #2 OR #3 OR #4 OR #5

1022595 records

[Intervention]

#7 (MH "Spinal Puncture")
2327 records

#7 TX (spinal puncture* OR lumbar puncture* OR spinal punction OR spinal tap) 
11999 records

#9 #7 OR #8
11999 records

#10 TX (position* OR lateral OR decubitus OR sitting OR prone OR upright OR recumbent OR tilt*)

639512 records

[Study design filter‐ Cochrane Neonatal standard RCT filter adapted for CINAHL via Ebsco https://neonatal.cochrane.org/Literature‐Search‐Filters‐for‐Neonatal‐Reviews]

#11 PT randomized controlled trial 
149705 records

#12 TI controlled controlled trial OR AB controlled controlled trial
169502 records

#13 TI ( randomized OR placebo OR drug therapy OR randomly OR trial OR groups ) OR AB ( randomized OR placebo OR drug therapy OR randomly OR trial OR groups )

1310338 records

#14 TX quasirandom* OR quasi‐random* OR randomi* OR randomly

667635 records

#15 TX control* AND (group OR grpups OR random OR trial OR trials OR study)

1649157 records

#16 #11 OR #12 OR #13 OR #14 OR #15

2349649 records

#17 (MH "Animals+")

105474 records

#18 (MH "Human")

2649268 records

#19 #17 NOT #18
95992 records

#20 #16 NOT #19
2323693 records

Combination search [Population, Intervention, Study design]

#21 #6 AND #9 AND #10 AND #20
2270 records

Number of records from databases (before deduplication)

2782 records

Trial registries

ClinicalTrials.gov (US National Library of Medicine)

Date of search: January 25, 2023

Condition: lumbar puncture OR spinal puncture OR lumbar punction OR spinal tap 
Other terms: Positioning

Filter‐ Child: (birth‐17)
7 records

Annotation:Also searched for Position

International Clinical Trials Registries Platform Search Portal, ICTRP (World Health Organization)

Date of search: January 24, 2023

Basic search

(spinal puncture OR lumbar puncture) AND (position OR lateral OR decubitus OR sitting OR prone OR upright OR recumbent OR tilt)

Recruitment status‐ALL

Phase‐ALL

77 records

Annotation: filtering on neonatal population retrieved zero results, records contain all age groups.

ISRCTN registry (BioMed Central/SpringerNature)

Date of search: January 24, 2023

Advanced search

(spinal puncture OR lumbar puncture) AND (position OR lateral OR decubitus OR sitting OR prone OR upright OR recumbent OR tilt)

16 records

Annotation: filtering on neonatal population retrieved zero results, records contain all age groups. Records form ISRCTN is saved as separate csv file.

Number of records from trial registries

104 records

Appendix 3. Risk of bias tool

We will use the standard methods of Cochrane and Cochrane Neonatal to assess the methodological quality of the trials. For each trial, we will seek information regarding the method of randomization, blinding, and reporting of all outcomes of all enrolled infants. We will assess each criterion as being at a low, high, or unclear risk of bias. Two review authors will separately assess each study. We will resolve any disagreements by discussion. We will add this information to the 'Characteristics of included studies' table. We will evaluate the following domains and enter the findings into the risk of bias table.

Sequence generation (checking for possible selection bias). Was the allocation sequence adequately generated?

For each included study, we will categorize the method used to generate the allocation sequence as:

• low risk (any truly random process, e.g. random number table; computer random number generator);

• high risk (any non‐random process, e.g. odd or even date of birth; hospital or clinic record number); or

• unclear risk.

Allocation concealment (checking for possible selection bias). Was allocation adequately concealed?

For each included study, we will categorize the method used to conceal the allocation sequence as:

• low risk (e.g. telephone or central randomization; consecutively numbered, sealed, opaque envelopes);

• high risk (open random allocation; unsealed or non‐opaque envelopes, alternation; date of birth); or

• unclear risk.

Blinding of participants and personnel (checking for possible performance bias). Was knowledge of the allocated intervention adequately prevented during the study?

For each included study, we will categorize the methods used to blind study participants and personnel from knowledge of which intervention a participant received. We will assess blinding separately for different outcomes or class of outcomes. We will categorize the methods as:

• low risk, high risk, or unclear risk for participants; and

• low risk, high risk, or unclear risk for personnel.

Blinding of outcome assessment (checking for possible detection bias). Was knowledge of the allocated intervention adequately prevented at the time of outcome assessment?

For each included study, we will categorize the methods used to blind outcome assessment. We will assess blinding separately for different outcomes or class of outcomes. We will categorize the methods as:

• low risk for outcome assessors;

• high risk for outcome assessors; or

• unclear risk for outcome assessors.

Incomplete outcome data (checking for possible attrition bias through withdrawals, dropouts, protocol deviations). Were incomplete outcome data adequately addressed?

For each included study and for each outcome, we will describe the completeness of data including attrition and exclusions from the analysis. We will note whether attrition and exclusions were reported, the numbers included in the analysis at each stage (compared with the total randomized participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information is reported or supplied by the trial authors, we will re‐include missing data in the analyses. We will categorize the methods as:

• low risk (< 20% missing data);

• high risk (≥ 20% missing data); or

• unclear risk.

Selective reporting bias. Are reports of the study free of the suggestion of selective outcome reporting?

For each included study, we will describe how we investigated the possibility of selective outcome reporting bias and what we found. For studies in which study protocols were published in advance, we will compare the prespecified outcomes versus the outcomes reported in the published results. If the study protocol was not published in advance, we will contact study authors to obtain the study protocol. We will assess the methods as:

• low risk (where it is clear that all the study's prespecified outcomes and all expected outcomes of interest to the review have been reported);

• high risk (where not all the study's prespecified outcomes have been reported; one or more reported primary outcomes were not prespecified outcomes of interest and are reported incompletely and so cannot be used; the study fails to include results of a key outcome that would be expected to have been reported); or

• unclear risk.

Other sources of bias. Was the study apparently free of other problems that could put it at high risk of bias?

For each included study, we will describe any important concerns we had about other possible sources of bias (e.g. whether there was a potential source of bias related to the specific study design, or whether the trial was stopped early due to some data‐dependent process). We will assess whether each study was free of other problems that could put it at risk of bias as:

• low risk;

• high risk; or

• unclear risk.

We plan to explore the impact of the level of bias by undertaking sensitivity analyses as necessary.

Data and analyses

Comparison 1. Lateral decubitus position versus sitting position.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Successful lumbar puncture procedure at the first attempt, with < 500 red blood cells/mm3	2	1249	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.85, 1.02]
1.2 Episodes of bradycardia	3	1279	Risk Ratio (M‐H, Fixed, 95% CI)	1.72 [1.08, 2.76]
1.3 Time to perform the lumbar puncture	1	20	Mean Difference (IV, Fixed, 95% CI)	2.00 [‐4.98, 8.98]
1.4 Episodes of desaturation (decrease of SpO2 to less than 80%)	2	1249	Risk Ratio (M‐H, Fixed, 95% CI)	2.10 [1.42, 3.08]
1.5 Apnea: number of episodes (interruption of breathing for more than 20 seconds) during the procedure	2	197	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable

Comparison 2. Lateral decubitus position versus prone position.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Successful lumbar puncture procedure at the first attempt, with < 500 red blood cells/mm3	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Guo 2022.

Study characteristics
Methods	RCT
Participants	171 newborns who satisfied the criteria for lumbar puncture indications. Included newborns with sepsis, meningitis, maternal syphilis, CSF drainage. 82 in prone position, 89 in standard lateral position. GA: 225.00 +/−23.4 days (lateral); 218.83 +/−19.4 (prone) Chronological age: mean 8 days Sex: lateral 52 boys, 37 girls; prone 47 boys, 35 girls Inclusion criteria: neonates with birthweights < 2500 g, who satisfied criteria for lumbar puncture. Exclusion criteria: birthweight > 2500 g, contraindications to lumbar puncture.
Interventions	Improved prone position. Neonate in prone position with limbs flexed, unlimited straightening, a butterfly pillow can be placed under the body, all were oriented mainly to the comfort of the neonate. Head tilted to one side. Operator first stood beside neonate to soothe (pacifier, milk, or 5% glucose). Standard lateral position. Neonate in lateral position with limbs flexed, unlimited straightening, a butterfly pillow can be placed under the body, all were oriented mainly to the comfort of the neonate. Head tilted to one side. Operator first stood beside neonate to soothe (pacifier, milk, or 5% glucose).
Outcomes	First attempt success rate; overall success rate; number of insertion attempts; adverse events (infection, bleeding, spinal nerve damage, epidermoidoma in the spinal canal, apnea, and bradycardia); pain (NIAPAS score); vital signs.
Funding
Country and setting	China. Second Hospital of Jilin University (neonatal unit?)
Protocol, informed consent and ethical approval	Retrospectively published protocol ChiCTR2100049923. Informed consent was obtained from parents of neonates regarding lumbar puncture. Protocol approved by Institutional Review Board of Second Hospital of Jilin University.
Notes	No vested interests.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "[Participants were] randomly divided [by a] random number generated by a computer."
Allocation concealment (selection bias)	Unclear risk	Quote: "Random number was kept in opaque envelope. Two doctors assigned to groups depending on odd/even number. The other trial personnel were not aware of allocation."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding not feasible due to the nature of the intervention.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Blinding not feasible due to the nature of the intervention.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear whether infants were excluded or dropped out following enrollment
Selective reporting (reporting bias)	Unclear risk	The protocol was retrospectively registered
Other bias	Low risk	No other sources of bias

Hanson 2016.

Study characteristics
Methods	RCT
Participants	167 children, age up to 90 days undergoing LP. GA: not reported Chronological age (mean): lateral 37 d; sitting 41 d Sex of participants: lateral 41 boys, 41 girls; sitting 46 boys, 39 girls Inclusion criteria: infants aged 1 to 90 days undergoing LP were eligible for inclusion; 82 in the lateral position, 85 in the sitting position. Exclusion criteria: bleeding disorder or coagulopathy, spinal abnormalities, lower extremity neurologic defects, previous LP attempt in the preceding 72 hours, LPs performed by consultant services, and patients whose parents or legal guardians did not speak primarily English or Spanish.
Interventions	Intervention: sitting position Comparison: lateral position
Outcomes	Primary: overall success rate. Secondary: first attempt success rate; complications (bleeding, apnea, respiratory distress, hypoxia, bradycardia); return visit related to LP within 1 month.
Funding	No vested interests.
Country and setting	USA. Tertiary care pediatric ER.
Protocol, informed consent and ethical approval	No published protocol was found. Written parental consent was obtained. The University of Utah Institutional Review Board approved this study.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "After written consent was obtained, LP providers opened a sealed randomization envelope, which assigned patients to one of the 2 positions." Sequence generation not specified.
Allocation concealment (selection bias)	Unclear risk	Quote: "a sealed randomization envelope". Not further specified if sequential or opaque.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding impossible because the study was about a different position during the procedure
Blinding of outcome assessment (detection bias) All outcomes	High risk	Blinding impossible because the study was about a different position during the procedure
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote "A total of 168 patients were enrolled (Fig. 1). One patient was excluded for being outside the specified age range. Of the167 who underwent randomization and were included in primary analysis, 82 (49%) were randomized to the lateral position. Ten patients had unsuccessful LPs on the first attempt and did not undergo a second LP attempt. In 9 of these patients, CSF was either sent for culture only or the CSF RBC count was 10,000 or greater.In 1 patient, respiratory distress precluded a second attempt"
Selective reporting (reporting bias)	Unclear risk	No protocol available
Other bias	Unclear risk	They were allowed to switch to a different position after the first attempt, both intention to treat and per protocol analysis reported.

Marshall 2022.

Study characteristics
Methods	RCT
Participants	1082 children with GA 27 + 0 to 44 + 0 undergoing lumbar puncture; 546 sitting, 536 lying. GA: sitting 40 weeks (39 to 41); lying 40 weeks (39 to 41) Chronological age: sitting 1 day (1 to 2), lying 2 days (1 to 2) Sex: sitting 325 boys, 218 girls; lying 336 boys, 197 girls Inclusion criteria: infants requiring a lumbar puncture at a corrected GA of 27 + 0 to 44 + 0 weeks, with a weight of 1000 g or more. Exclusion criteria: already had a lumbar puncture for the same indication, were on ventilation, were unable to be held in sitting position, or if sitting was deemed to be difficult or unsafe.
Interventions	Sitting position where the infant is held in a semi‐upright, sitting position. Lying position (lateral decubitus). Early stylet removal involves removal after transecting the skin and subcutaneous tissue, before slowly advancing the needle tip into the CSF. Late stylet removal involves inserting the needle into the CSF space before removing the stylet.
Outcomes	Primary: first attempt success rate (CSF with RBC < 10,000 cells/μL). Secondary: short‐term clinical measures (alternative RBC thresholds; CSF appearance; WBC and RBC counts; number of procedures and attempts per infant; proportions with different CSF‐based diagnoses; time taken; infant movement); healthcare resource use (duration of antibiotics and length of stay); safety metrics (cardiorespiratory stability and adverse events). Parental anxiety assessment was not analyzed. Infant movement on 4‐point scale.
Funding	UK National Institute for Health and Care Research
Country and setting	21 centers in the UK providing newborn care.
Protocol, informed consent and ethical approval	Pre‐published protocol, ISRCTN14040914. Parents gave informed consent before randomization. Ethics approval was received from the NHS Health Research Authority.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Infants were randomly assigned (1:1:1:1) using a 24/7, webbased, secure, central randomisation system (to conceal allocations). "
Allocation concealment (selection bias)	Low risk	Quote: "Infants were randomly assigned (1:1:1:1) using a 24/7, webbased, secure, central randomisation system (to conceal allocations). "
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Masking of practitioners and parents was not possible, but the primary outcome was based on laboratory tests performed by technicians who were masked to allocation."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Masking of practitioners and parents was not possible, but the primary outcome was based on laboratory tests performed by technicians who were masked to allocation."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "1082 infants were randomly assigned to sitting (n=546) versus lying (n=536) position, and early (n=549) versus late (n=533) stylet removal (figure 1). 1079 infants had a first lumbar puncture; 166 (15·4%) had a second lumbar puncture (each of these lumbar puncture procedures involved one or more attempts). Nine infants were withdrawn from followup during the trial, but for eight of them consent was only withdrawn after data collection for the primary outcome, so they were not excluded from this analysis. One infant had consent with­drawn before data collection for the primary outcome, three infants did not receive a lumbar puncture, and two had missing consent forms, so that six in total were excluded, leaving 1076 for the final analysis (figure 1). All infants who were included in the final analysis were followed up until discharge."
Selective reporting (reporting bias)	Low risk	Quote: "The outcomes pre‐specified in the protocol have been reported."
Other bias	Low risk	Quote: "No other sources of bias"

Vila 2002.

Study characteristics
Methods	RCT
Participants	30 preterm infants scheduled for inguinal herniotomy under spinal anesthesia: 15 undergoing lumbar puncture in standard lateral position and 15 in sitting position. GA at birth: mean (SD) (range): lateral position group 30.2 (2.6) (26 to 34); sitting position group 30.7 (2.9) (27 to 35). GA at the moment of the procedure: mean (SD) (range): lateral position group 35.2 weeks (1.1) (34 to 37); sitting position group 35.5 weeks (1.0) (34 to 37). Male/female ratio: lateral position group 8/7; sitting position group 9/6. Inclusion criteria: preterm infants scheduled for inguinal herniotomy under spinal anesthesia. Exclusion criteria: systemic infection, coagulopathy, and infection at the lumbar puncture site.
Interventions	Sitting position vs lateral standard position.
Outcomes	Spinal anesthesia success; median (range) number of attempts; number of bloody taps; median (range) maximum dermatomal block height; median (range) duration of motor block; median (range) duration of surgery; vitals (hemodynamic data, apnea, bradycardia). Need for postoperative paracetamol administration. Median (range) time to first administration of paracetamol. No exclusions, no lost to follow‐up are reported; however, this is not unlikely due to the reduced sample size, type of patient, and duration of follow‐up.
Funding	No vested interests.
Country and setting	Neonatal care unit of a university hospital in Barcelona (Spain). Patients undergoing inguinal herniotomy under spinal anesthesia.
Protocol, informed consent and ethical approval	No protocol available. Written informed parental consent was obtained. Local research ethics committee approval was obtained.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomly assigned to one of two equal groups", not further specified.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding was not impossible
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "Measurement and recording of all physiological parameters were performed by blinded observers." Otherwise not specified.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No exclusions, no lost to follow up are reported. However, this is not unlikely due to the reduced sample size, type of patient and duration of follow‐up.
Selective reporting (reporting bias)	Unclear risk	No protocol available. Multiple outcomes not reported in methods, only results. Multiple planned outcomes not reported upon.
Other bias	Low risk	No other sources of bias

Weisman 1983.

Study characteristics
Methods	Quasi‐randomized trial
Participants	26 neonates undergoing LP as part of a suspected sepsis evaluation: 10 undergoing lumbar puncture in standard lateral position, 10 in sitting position, and 6 in modified lateral position. GA at the moment of the procedure: mean (SD): standard lateral position group 33.6 weeks (4.2); sitting position group 33.5 weeks (5.4); modified lateral position group 33.8 weeks (3.4) Chronological age mean (SD): standard lateral position group 4.9 hours (5.5); sitting position group 5.2 hours (5.6); modified lateral position group 4.9 hours (4.6) Male/female ratio not reported. Inclusion criteria: consecutive neonates, less than 24 hours of age, who were to have lumbar punctures as part of a suspected sepsis evaluation and whose parents gave consent for participation. Exclusion criteria: not specified.
Interventions	Sitting position vs modified lateral position vs standard lateral position. Sitting position: infant's hips flexed 90 degrees, with knees extended (no abdominal compression). Modified lateral: on left side, with hips flexed only 90 degrees, with legs extended at the knees (no abdominal compression). Standard lateral position: on left side with hips flexed to place knees to chest (abdominal compression). In all positions the neck was not extended or flexed.
Outcomes	TcPO2 at baseline and transition periods, evaluating also whether it depends on the position; intraesophageal pressure; blood pressure, heart and respiratory rate; successful LPs; time to perform LP. No information on dropouts or exclusions, despite the 3 groups consisting of 10, 10, and 6 infants, respectively, within a quasi‐RCT.
Funding	No vested interests.
Country and setting	Neonatal department of Walter Reed Army Medical Center (Washington, DC, USA).
Protocol, informed consent and ethical approval	No protocol available. Informed parental consent was obtained. Institutional review committee approval was obtained prior to initiation of the study.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quasi‐RCT. Quote: "Patients were assigned to one of six study groups based on their hospital admission number."
Allocation concealment (selection bias)	High risk	Quote: "Patients were assigned to one of six study groups based on their hospital admission number."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding impossible because they study involved different positions during the procedure.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinding impossible because they study involved different positions during the procedure.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No information on dropouts or exclusions, despite the three groups consisted of 10, 10 and 6 infants, respectively, within a quasi‐RCT
Selective reporting (reporting bias)	Unclear risk	No protocol available
Other bias	Low risk	No other sources of bias

CSF = cerebral spinal fluid; ER = emergency room; GA: gestational age; LP = lumbar puncture; NIAPAS = Neonatal Infant Acute Pain Assessment Scale; NHS = National Health Service; RBC = red blood cell; RCT = randomized controlled trial; SD = standard deviation; TcPO₂ = transcutaneous partial pressure of oxygen; WBC = white blood cell.

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Apiliogullari 2008	Wrong population: newborns were only a minor proportion of the randomized participants undergoing LP (inclusion criteria: between 1 month and 12 years of age)
NCT02834156	Wrong population: not in newborns
NCT04070144	Wrong population: not in newborns
NCT04828746	Compares LP with ultrasound vs without ultrasound, not different positions
Zhuang 2022	Wrong population: not in newborns

LP = lumbar puncture.

Characteristics of studies awaiting classification [ordered by study ID]

Hanson 2013.

Methods	Randomized controlled trial (according to the title of this conference abstract)
Participants	Infants undergoing lumbar puncture (according to the title of this conference abstract)
Interventions	Information not available.
Outcomes	Information not available.
Notes	Abstract not available.

Characteristics of ongoing studies [ordered by study ID]

CTRI/2015/10/006280.

Study name	Lumbar puncture in sitting versus lateral recumbent position with or without use of topical anesthetic agent in neonates: a factorial randomized control trial
Methods	RCT, 2 x 2 factorial design
Participants	Total sample size: 236 newborn infants, up to 30 days old, in India. Inclusion criteria: all neonates admitted to NICU who are planned to undergo lumbar puncture as decided by the treating physician. Exclusion criteria: intraventricular hemorrhage, mechanical ventilation, neonatal encephalopathy, congenital anomaly, neural tube defects, vertebral defects, other gross congenital anomalies, local skin inflammation or infection or exudative skin lesion, cardiovascular instability, surgery in preceding 7 days, received muscle relaxants, sedatives, and analgesia during previous 24 hours, failure to obtain consent.
Interventions	Lumbar puncture in sitting or lateral recumbent position, with topical anesthetic EMLA (1 g) or placebo. EMLA or placebo to be applied over lumbar area, once per baby in a 48‐hour period, duration for 1 hour under tight occlusion.
Outcomes	Primary outcome: successful lumbar puncture defined as obtaining a non‐hemorrhagic CSF (grossly clear CSF or CSF RBC count 1000/mm3, or both). Time point: immediately at end of lumbar puncture—0 min at end of lumbar puncture. Secondary outcomes: Physiological parameters: heart rate, transcutaneous oxygen saturation, and PCO2 Pain scores assessed as per PIPP score Occurrence of adverse skin reaction like blanching, rashes, erythema, purpuric lesion at site of application Number of attempts taken for successful lumbar puncture. Time point: 24 hour after end of procedure
Starting date	5 October 2014
Contact information	Dr Satish Saluja, satishsaluja@gmail.com Dr Susanta Kumar Badatya, satishsaluja@gmail.com
Notes

CSF = cerebral spinal fluid; EMLA = eutectic mixture of local anesthesia; NICU = neonatal intensive care unit; PCO₂ = partial pressure of carbon dioxide; PIPP = Premature Infant Pain Profile; RBC = red blood cell count; RCT = randomized controlled trial.

Differences between protocol and review

We made the following changes to the protocol (Pessano 2023b):

• Marcus Prescott co‐authored the review but not the protocol;

• in the protocol we planned to include a summary of findings table for each of the specified comparisons in Types of interventions. In the review we did not create a summary of findings table for sitting versus prone position, as no studies were included in this comparison.

Contributions of authors

SP: developed, contributed to writing and editing, made an intellectual contribution to, advised on and approved the final version prior to submission.

MB: conceived the review question; made an intellectual contribution to, advised on and approved the final version of the review prior to submission; is a guarantor of the review.

MP: developed, contributed to writing and editing, made an intellectual contribution to, advised on and approved the final version prior to submission.

OR: produced the first draft of the protocol; contributed to writing and editing; made an intellectual contribution to and approved the final version prior to submission.

Sources of support

Internal sources

• Institute for Clinical Sciences, Lund University, Lund, Sweden

  MB and OR are employed by this organization.

External sources

• Vermont Oxford Network, USA

  Cochrane Neonatal Reviews are produced with support from Vermont Oxford Network, a worldwide collaboration of health professionals dedicated to providing evidence‐based care of the highest quality for newborn infants and their families.

• Region Skåne, Skåne University Hospital, Lund University and Region Västra Götaland, Sweden

  Cochrane Sweden is supported from Region Skåne, Skåne University Hospital, Lund University and Region Västra Götaland

Declarations of interest

SP has no interest to declare.

MB is an Associate Editor for the Cochrane Neonatal Group. However, his participation in the editorial group has not impacted this review.

MP has no interest to declare.

OR has no interest to declare.

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