Ngan 2017.
Methods | Prospective randomised parallel controlled trial Setting: Delivery Room, NICU, Royal Alexandra Hospital (RAH), Edmonton, Canada Conducted: June 2013 to August 2014 |
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Participants | Inclusion criteria: infants between 23+0 and 32+6 weeks of gestation who require respiratory support for resuscitation in the delivery room Exclusion criteria: congenital abnormality or condition that might have an adverse effect on breathing or ventilation; absence of parents' consent for inclusion in the study |
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Interventions |
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Outcomes | Primary outcome: BPD (rate of respiratory support or supplemental oxygen at corrected gestational age of 36 weeks) Secondary outcomes: rate of endotracheal intubation in the DR or the NICU, duration of MV and non‐invasive ventilation, neonatal death, air leak, PDA (medical or surgical), NEC, ROP, periventricular leukomalacia, abnormal cranial ultrasound (including IVH, parenchymal injury, and ventriculomegaly), surfactant administration, postnatal steroids, respiratory support or oxygen requirements at 28 days, neonatal death before discharge |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation scheme (1:1 ratio). Randomisation stratified according to gestational age (to infants 23+0 to 27+6 and 28+0 to 32+6 weeks). Twins and/or triplets were randomised as individuals |
Allocation concealment (selection bias) | Unclear risk | A sequentially numbered, brown, sealed envelope contained a folded card box with treatment allocation opened by the clinical team immediately before delivery. Timing of randomisation resulted in many post‐randomisation exclusions with the potential of inadequate allocation concealment, as more post‐randomisation exclusions occurred in the SLI group than in the control group |
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 | Low risk | After admission into the NICU, the clinical team was not made aware of treatment allocation. In addition, both data collector and outcome assessor were unaware of group allocation. The research team was not involved in clinical care of the infants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Post‐randomisation exclusion (27%) resulted in fewer included infants in the SLI group; this discrepancy might have yielded different results |
Selective reporting (reporting bias) | Low risk | Protocol was registered at ClinicalTrials.gov (NCT01739114) |
Other bias | Unclear risk | Planned sample size of 93 infants in each group was not achieved. Moreover, incidence of the primary outcome in the control group was lower than assumed for the sample size calculation, further underpowering the trial to detect the desired effect size |