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. 2020 Mar 18;2020(3):CD004953. doi: 10.1002/14651858.CD004953.pub4

Jiravisitkul 2017.

Methods Prospective randomised parallel controlled trial
Setting: delivery room of Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
Conducted: November 2013 to March 2015
Participants Included: 81 preterm infants (25 to 32 weeks of gestational age) requiring positive‐pressure ventilation or continuous positive airway pressure
Exclusion criteria: major congenital anomalies, hydrops foetalis, prenatal diagnosis of upper airway obstruction, meconium‐stained amniotic fluid
Interventions
  • SLI group (n = 43): SLI at 25 cmH₂O for 15 seconds with neonatal mask via a T‐piece resuscitator, followed by delivery of CPAP at 6 cmH₂O via a face mask for 5 to 10 seconds. Cardiorespiratory status was then re‐evaluated. If HR was ≥ 100 beats/min and respiratory effort was improved, CPAP was continued via face mask. If HR was < 60 beats/min, PPV was initiated. If HR was 60 to 100 beats/min and/or respiratory effort was poor, a second SLI manoeuvre similar to the first SLI manoeuvre was initiated. If HR was < 100 beats/min or gasping/apnoea was present during the second SLI manoeuvre, PPV was initiated and additional resuscitation steps performed. If HR was ≥ 100 beats/min and no apnoea/gasping was present during the second SLI manoeuvre, CPAP was performed via face mask

  • Non‐SLI group (n = 38): standard resuscitation alone. PPV was given via a T‐piece resuscitator with PIP of 15 to 20 cmH₂O and PEEP of 5 cmH₂O for 30 seconds. Infants were placed on CPAP at 6 cmH₂O via face mask if breathing was still laboured


All enrolled infants were resuscitated with an initial fraction of inspired oxygen (FiO₂) of 0.3, which was adjusted by 0.1 every 30 seconds to achieve the target SpO₂. Criteria for intubation included 1 of the following: remaining apnoeic after PPV; HR of 30 seconds before the start of chest compressions; or SpO₂ < 80% despite CPAP via mask with FiO₂ of 1.0 for 5 to 10 minutes
Infants of multiple gestations were enrolled in the same intervention group
Outcomes Primary outcomes: change in oxygen requirements, HR, and SpO₂ during resuscitation; proportion of infants on room air during first 10 minutes after birth; rate of intubation in the delivery room
Secondary outcomes: survival at discharge, duration of hospitalisation, proportion of infants on MV within first 72 hours of life, duration of MV, duration of oxygen supplementation, rate of surfactant, rate of postnatal steroids, pneumothorax within first 48 hours after NICU admission, moderate to severe BPD as defined by Jobe and Bancalari, Apgar score at 5 minutes, PDA and rate of surgical closure, grade 3 to 4 IVH, cystic periventricular leukomalacia, stage > 2 ROP, ROP requiring treatment
Notes Study was registered in the Thai Clinical Trials Registry (TCTR20140418001)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block of 4 randomisation stratified by GA: 25 to 28 weeks and 29 to 32 weeks. Random sequence was generated by computer random number generator (information provided by study authors)
Allocation concealment (selection bias) Low risk Sequence numbers were kept in opaque sealed envelopes that were opened just before birth in the delivery room by a person not involved in resuscitation of infants
Blinding (performance bias and detection bias) 
 All outcomes High risk Assigned intervention could not be blinded to the resuscitation team
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information provided
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear why 43 infants in SLI group and 38 in control group
Selective reporting (reporting bias) Unclear risk According to the Thai Clinical Trials Registry (TCTR20140418001), the only primary outcome was intubation in DR; only a key secondary outcome was specified: BPD
Other bias Unclear risk Planned sample size: 40 infants in each group; however, only 38 in control group