Jiravisitkul 2017.
Methods | Prospective randomised parallel controlled trial Setting: delivery room of Ramathibodi Hospital, Mahidol University, Bangkok, Thailand Conducted: November 2013 to March 2015 |
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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 |
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Interventions |
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 |
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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 |
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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 |