Abstract
This is a protocol for a Cochrane Review (Overview). The objectives are as follows:
The aim of this study is to evaluate the benefits and harms of different interventions used in the management of TTN of the newborn.
Background
Description of the condition
Transient tachypnoea of the newborn (TTN) is a respiratory disorder that occurs in full‐term (≥ 37 weeks' gestation) or late preterm (34 to 36 weeks' gestation) infants. TTN consists of tachypnoea, defined as respiratory rate above 60/min that is self‐limiting and usually lasts up to a couple of days. Although the diagnosis is based on clinical symptoms and signs of respiratory distress (chest wall retractions, flaring of nostrils, grunting), chest X‐ray may support the differential diagnosis (Edwards 2013).
TTN is caused by inadequate clearance of lung fluid after the transition from living in the womb to breathing air (Avery 1966; McGillick 2017). The pathophysiology may involve a dysregulation in the change from a secretive to an absorptive function of the lungs. TTN is associated with factors that hasten this transition, such as elective caesarean section and fast delivery (Cohen 1985; Hansen 2008). Risk factors include macrosomia, maternal diabetes, twin pregnancy, and family history of asthma (Edwards 2013; Liem 2007). TTN is the most common cause of respiratory distress among infants (Clark 2005), with an overall incidence around 0.5% to 2.8%, which may reach up to 30% in term infants delivered by elective caesarean section with its inherent lack of initiation of labor and subsequent changes in reabsorptive processes in the lungs (Hansen 2008; Hibbard 2010; Kumar 1996; Morrison 1995). Respiratory distress is a common reason for admission of term infants to neonatal units, and TTN is the reason for approximately 10% of all admissions of term infants to neonatal units (Edwards 2013).
Although TTN is a self‐limiting condition that usually leaves no sequelae, tachypnoea may interfere with enteral feeding; may require testing and close monitoring along with oxygen therapy; and may be a cause of great concern for parents (Hack 1976). Studies have shown an association between TTN and asthma, bronchiolitis, and other wheezing syndromes later in life (Liem 2007), as well as persistent pulmonary hypertension in rare cases (Miller 1980;Tudehope 1979).
TTN may be confused with the early stages of other, more significant respiratory conditions such as early‐onset pneumonia or respiratory distress syndrome, and to some extent is a diagnosis of exclusion.
Description of the interventions
Beta‐agonists (β‐agonists)
β‐Agonists are drugs that activate β‐adrenergic receptors. These receptors play a vital role in the switch from secretion to absorption that takes place in the foetal lung epithelium at birth. The surge of endogenous catecholamines during labor leads to lung fluid resorption through increased expression of epithelial sodium channels and increased activity of sodium‐potassium adenosine triphosphatase (Na+/K+–ATPase) (Barker 2002).
This is consistent with the observation that TTN is more common with caesarean sections, which might not induce this rise of adrenaline in the foetal circulation (Irestedt 1982). Given that deficiency of catecholamines is one of the causes of TTN, exogenous β‐agonists may serve as potentially effective treatment (Hansen 2008). β‐Agonists have been shown to reduce lung fluid (Perkins 2006; Sakuma 1997; Sartori 2002). Examples of β‐agonists are salbutamol (albuterol), adrenaline (epinephrine), and noradrenaline (norepinephrine). These are administered mainly as inhalation therapy and intravenous injection/infusion. β‐Agonists are associated with adverse effects such as tachycardia, other arrhythmias, and vasoconstriction leading to hypertension. Dosage, type of drug, and route of administration (inhalation, intravenous, oral) are factors that might affect these risks; adrenaline for instance seems to have greater effects on systemic circulation as compared with salbutamol (Becker 1983).
Postnatal steroids
Plasma cortisol is important for the development of correct epithelial sodium channel (ENaC) expression in the lung epithelia (Barker 2002), and exogenous steroids might accelerate lung maturity when this process does not develop naturally.
Antenatal administration of corticosteroids reduces the risk of TTN in near‐term foetuses (Saccone 2016); this treatment has also been shown to reduce the risk of respiratory distress (Roberts 2017). However, the harms of corticosteroid treatment may outweigh the benefits because TTN is such a benign disorder. Moreover, a large proportion of women would be exposed to this prophylactic measure when only a few of them would have a newborn with TTN, thus leading to over‐treatment (Saccone 2016).
Many types of corticosteroids, such as betamethasone, hydrocortisone, budesonide, and dexamethasone, may be used. Routes of administration include inhalation, infusion, injection, and dermal and enteral routes.
Possible harms associated with corticosteroid treatment include neonatal hypoglycaemia, gastrointestinal bleeding, infection, and, possibly, impaired neurological development, although evidence for the latter is limited to studies in very preterm infants (Linsell 2016; Saccone 2016; Stark 2001).
Diuretics
Diuretics are drugs that affect fluid regulation, usually through inhibition of electrolyte reabsorption in the kidney, which leads to increased loss of salts and fluids. Diuretics that have been used to treat patients with TTN include furosemide and bumetanide, both of which inhibit chlorine/sodium channels in the looping nephron.
Furosemide has been shown to be an effective treatment for other pathologies involving lung fluids in adults such as lung oedema after myocardial infarction (Biddle 1979). In neonatology, diuretics are often used for management of chronic lung disease in newborns who are born extremely preterm, although this approach is not supported by appropriate evidence. Besides providing a diuretic effect, furosemide has been shown to confer beneficial direct effects in the newborn lung, although this benefit appears to be temporary (Bland 1978).
Adverse effects associated with furosemide include dehydration, hypotension, hypochloraemia, hypokalaemia, hyponatraemia, and kidney injury (Spino 1978).
Fluid restriction
Restricting the amount of fluid available to the newborn seems a reasonable, feasible, and cheap intervention, as TTN is caused by an increased amount of fluids in the lungs. Mild fluid restriction has been reported to be safe for term and late preterm neonates with TTN (Dehdashtian 2014; Stroustrup 2012).
Fluid intake of the infant is calculated as a combination of intravenous and enteral fluid intake. Normally, babies receive about 60 to 80 mL/kg/d of fluids on the first day of life, and on each day following that day, the amount is increased by about 20 mL until a dosage of about 150 mL/kg/d is reached. Fluid restriction as practised in the cited study means that the infant receives 40 to 60 mL/kg/d at first, and after that, the same ratio of increase is applied (Stroustrup 2012).
Adverse effects associated with fluid restriction include electrolyte imbalance, dehydration, and jaundice (Stroustrup 2012). Fluid restriction might limit the possibility of breast‐feeding or parenteral nutrition, and this can cause stress for both parents and healthcare personnel and discomfort for the baby.
Non‐invasive respiratory support
Non‐invasive respiratory support includes any respiratory support with no endotracheal or tracheostomy tube. This approach decreases the risk of damage to larynx and trachea, preserves newborn laryngeal function (adduction of the vocal cords during expiration), and may reduce the risk of nosocomial infection. Non‐invasive respiratory support is used to decrease respiratory distress and discomfort in the tachypnoeic infant (Alexiou 2016; Cordero 1997).
The type of respiratory support used depends mainly on the severity of TTN and on the availability of equipment in the neonatal unit. Modes of ventilation include:
high‐flow nasal cannula (HFNC) – a nasal cannula that provides heated and humidified gas at a flow of 1 litre/min or higher (Wilkinson 2016);
continuous positive airway pressure (CPAP) – a system that delivers continuous positive pressure that prevents collapse of respiratory ducts and alveoli. Can be used with a variety of systems, including face mask, nasal mask, or prongs (De Paoli 2003);
nasal intermittent positive‐pressure ventilation (NIPPV) ‐ a system by which nasal mask or prongs are used for delivery. Similar to CPAP but adds on inflations to a peak pressure. Some machines can synchronise, to some extent, with the patient's own attempts at breathing (Lemyre 2017); and
nasal high‐frequency (oscillation) ventilation (NHFV) ‐ a newer form of respiratory support that has been suggested to be effective for quicker clearing of carbon dioxide (Fischer 2015).
Long exposure to positive pressures can lead to barotrauma and volume injury, which are seen primarily in preterm infants (Zielinska 2014). However the lungs of late preterm and full‐term infants are likely to be less vulnerable.
How the intervention might work
Given that the main issue in TTN is delayed clearance of lung fluid, the aim of most treatments is to remove this excess fluid. Drugs such as catecholamines and steroids facilitate the natural absorption of lung fluid by increasing the number of ENaC membrane channels in the alveolar cells. Diuretics eliminate salt via urine and therefore lead to more osmolar blood, which in turn draws water from the interstitium into the vascular system. Diuretics such as furosemide have also been shown to have a local effect in improving pulmonary dynamics directly. Fluid restriction seems to be the most straightforward approach and can help with fluid regulation through increased clearance of free water from the lung. Respiratory support is seen as a way to support the child through a period of impaired breathing and as a triggering event by which to clear fluid from the lungs. Animal studies suggest that oxygen itself might lead to increased clearance of lung fluid through increased expression of certain membrane channels (Barker 2002). Oxygen is provided mainly to support the infant while lung fluid is cleared via normal physiological mechanisms.
Why it is important to do this overview
Although TTN usually resolves within 48 hours, the infant may benefit from neonatal care with respiratory support provided during this time. This intensive care might be traumatic for parents, can limit parent‐child bonding, and might delay the first breast‐feeding (Dehdashtian 2018). In addition, unnecessary and ineffective treatments for TTN could cause harm through adverse effects. Neonatal care with respiratory support is resource and personnel intensive. Shortening of treatment time in TTN can save resources ‐ especially nowadays, when caesarean sections are becoming more common in some countries (Stroustrup 2012).
Several factors are associated with an increased incidence of TTN, including caesarean section, macrosomia (birth weight greater than two standard deviations for gestational age), maternal diabetes, family history of asthma, and twin pregnancy (Hansen 2008). Because these prenatal risk factors are widespread, most cases of TTN occur in level 1 neonatal units, where resources for immediate respiratory support may be suboptimal and expertise for its use might be lower. Therefore, it would be advantageous to identify effective and safe interventions that can be applied in this setting, which would improve the management of TTN and subsequently reduce the need for intensive care with or without transfer to a level 3 neonatal intensive care unit.
This overview aims to provide a coherent up‐to‐date summary of the totality of evidence, without the need to access many individual systematic reviews. It is hoped that this may prove helpful to clinicians, policy makers, childbirth educators, and consumers.
Objectives
The aim of this study is to evaluate the benefits and harms of different interventions used in the management of TTN of the newborn.
Methods
Criteria for considering reviews for inclusion
Type of studies
We will include all published Cochrane Reviews on management of TTN.
Types of participants
We will include Cochrane Reviews studying patients who are born at term (> 37 weeks' gestation) or late preterm (34 to 36 weeks' gestation).
Transient tachypnoea will be defined as a respiratory rate above 60 breaths/min and might have characteristics of respiratory distress such as grunting, flaring, and chest wall retraction. Other causes of respiratory distress, such as pneumonia and pneumothorax, must not be present (Reuter 2014). We will also accept slightly different definitions of TTN if it is clear that studies are describing the same condition.
Types of interventions
We will assess the following categories of interventions: steroids, β‐agonists, non‐invasive respiratory support, diuretics, and fluid restriction (see Description of the interventions).
Interventions must be started within the first 48 hours of life as onset of TTN occurs within the very first hours of life.
This is an overview of systematic reviews and is not a review of primary studies: because of the large number of possible comparisons among these interventions, we do not plan to specify in advance the comparisons to be included. We expect to retrieve reviews comparing the above mentioned interventions to:
placebo;
no treatment; or
other interventions.
Types of outcome measures
Primary outcomes
Duration (hours) of tachypnoea
Need for mechanical ventilation (yes/no)
Secondary outcomes
Time (hours) to established breast‐feeding or bottle‐feeding
Duration (hours) of hospital stay
Clinical assessment of respiratory distress as quantified by Silverman or Downes' score > 6 (indicative of impending respiratory failure) (yes/no) 24 and 48 hours after study entry (Silverman 1956; Wood 1972)
Neonatal mortality (within 28 days of life)
Any adverse events as reported in the included reviews, including the following: pneumothorax (for non‐invasive respiratory support), tachycardia (for epinephrine and salbutamol), hyperglycaemia (for corticosteroids), gastrointestinal bleed (for corticosteroids), dehydration (for fluid restriction and diuretics), or electrolyte disturbances (for fluid restriction, β‐agonists, and diuretics)
Search methods for identification of reviews
We will conduct a search of the Cochrane Database of Systematic Reviews Library ‐ ongoing and published ‐ on the topic of TTN.
Data collection and analysis
Methods used here will be based on Chapter 22 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2019).
Selection of reviews
Reviews on management of TTN will be checked for inclusion by two independent review authors. We plan to resolve any disagreement through discussion or, if required, to consult a third review author.
Data extraction and management
Two overview authors will independently extract data from the reviews using a pre‐defined data extraction form. We will resolve disagreements by discussion with a third overview author.
We will extract the following from each review.
Review title and authors.
Objective and research question.
Date of publication.
Number of included trials.
Number of participants.
Interventions and comparisons.
Outcomes.
Effect measurements for the pre‐specified outcomes of this overview.
GRADE (Grading of Recommendations Assessment, Development and Evaluation) tables by which to judge evidence.
Strengths and limitations.
Assessment of methodological quality of included reviews
Two review authors will independently assess the methodological quality of included reviews using the AMSTAR‐2 (A MeaSurement Tool to Assess systematic Reviews) measurement tool (Shea 2017). This instrument has good inter‐rater agreement, test‐retest reliability, and face and construct validity (Shea 2017). Specifically, we will address the following questions.
Did the research questions and inclusion criteria for the review include the components of PICO?
Did the report of the review contain an explicit statement that review methods were established before conduct of the review?
Did the report justify any significant deviations from the protocol?*
Did review authors explain their selection of study designs for inclusion in the review?
Did review authors use a comprehensive literature search strategy?*
Did review authors perform study selection in duplicate?
Did review authors perform data extraction in duplicate?
Did review authors provide a list of excluded studies and justify exclusions?*
Did review authors describe the included studies in adequate detail?
Did review authors use a satisfactory technique for assessing risk of bias (RoB) in individual studies that were included in the review?*
Did review authors report on sources of funding for studies included in the review?
If meta‐analysis was performed, did review authors use appropriate methods for statistical combination of results?*
If meta‐analysis was performed, did review authors assess the potential impact of RoB of individual studies on results of the meta‐analysis or other evidence synthesis?
Did review authors account for RoB in individual studies when interpreting/discussing results of the review?*
Did review authors provide a satisfactory explanation for, and discussion of, any heterogeneity observed in results of the review?
If they performed quantitative synthesis, did review authors carry out an adequate investigation of publication bias (small study bias) and discuss its likely impact on results of the review?*
Did review authors report any potential sources of conflict of interest, including any funding received for conducting the review?
Possible responses to each question are 'yes' and 'no'. A “partial yes” response is applicable in some instances (Shea 2017). We will provide rationale for judgments for each AMSTAR item. Seven of 16 domains (marked with an * in the list above) are defined as critical because they can 'critically' affect the validity of a review. We did not report a summary score, as recommend by developers of AMSTAR‐2 (Shea 2017). However, the potential impact of an inadequate rating for each item will be considered.
Quality of the body of evidence in included reviews
We will create 'Summary of findings' tables for the primary outcomes. We will assess the quality of evidence for effects of interventions for TTN management by using the GRADE approach (Guyatt 2011). When 'Summary of findings' tables will not be available in the included reviews, or will not completely match the PICO of this overview, we plan to prepare them from scratch. When such tables are reported in the included reviews, we will 're‐grade' the quality of evidence of the three primary outcomes to ensure a homogeneous assessment. Potential discrepancies with original reviews will be discussed in this overview. We will grade the quality of evidence by considering the following criteria: study limitations (i.e. risk of bias), consistency of effect, imprecision, indirectness, and publication bias.
Data synthesis
We will provide a narrative summary of the methods and results of each of the included reviews and will summarise this information using tables and figures (e.g. characteristics of included reviews, summary of quality of evidence within individual systematic reviews, AMSTAR‐2 evaluation) for each systematic review.
For primary and secondary outcomes, we will report effect estimates and 95% confidence intervals (CIs) as reported in the meta‐analyses conducted by authors of the systematic reviews when available.
We will re‐format data in text, tables, and figures. A table on outcomes shows comparisons; numbers of participants and studies; measures of effect with 95% CIs; I²; and certainty of evidence (GRADE).
We will not pool data derived from different reviews in meta‐analyses, as we expect substantial heterogeneity. We will not draw inferences about the comparative effectiveness of multiple interventions (i.e. avoid any ranking that would require network meta‐analysis). However, we plan to classify interventions that are effective for the primary outcomes of this review and those that are not, according to effect estimates and 95% CIs as reported in the meta‐analyses conducted by authors of the systematic reviews. However, if some details needed for this overview will be available only from the original primary studies (e.g. gestational age), we plan to analyse reports of the studies included in each review to re‐calculate effect estimates and 95% CIs (fixed‐effect model) by using RevMan (Review Manager 2014). Whenever feasible, we will summarise data on primary outcomes in 'Summary of findings' tables, as described in Chapter 11 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2019). We will construct tables based on each comparison using the GRADE profiler (GRADEpro; http://tech.cochrane.org/revman/gradepro).
If data are available, we will report on the following subgroups.
Birth weight: ≤ 2500 grams; > 2500 grams.
Gestational age: term (> 37 weeks' gestation) or late preterm (34 to 36 weeks' gestation).
Antenatal steroid exposure.
For future updates of this overview, if the data allow, we may perform some indirect comparisons of interventions across reviews for the primary outcomes.
Acknowledgements
We thank Roger Soll and Colleen Ovelman for their valuable advice.
Contributions of authors
MB and KOH reviewed the literature and wrote the protocol.
LM and OR assisted in the review of literature and in writing of the protocol.
RB and MGC commented on and reviewed the protocol.
Sources of support
Internal sources
-
Institute for Clinical Sciences, Lund University, Lund, Sweden.
MB and OR are employed by this organisation
-
Istituto Giannina Gaslini, Genoa, Italy.
MGC is employed by this organisation
-
Pediatric and Neonatology Unit, Ospedale San Paolo, Savona, Italy.
LM is employed by this organisation
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.
Declarations of interest
MB has no interests to declare.
KOH has no interests to declare.
RB has no interests to declare.
MGC has no interests to declare.
LM has no interests to declare.
New
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