Abd 2017.
Methods | Prospective randomised parallel controlled trial Setting: delivery room of Maternity Hospital, Mansoura University Children's Hospital, Egypt Conducted: March 2013 to June 2016 |
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Participants | Inclusion criteria: preterm infants born ≤ 32 weeks' gestation with RDS. Exclusion criteria: major congenital anomalies. |
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Interventions |
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Outcomes | Primary outcome: rate of endotracheal intubation in the delivery room. Secondary outcomes: rate of MV (within 72 hours), duration of MV, duration of CPAP support, rate of surfactant (within 72 hours), death before hospital discharge, BPD (within 90 days), IVH (within 14 days), ROP (within 50 days), NEC (within 40 days), hospital stay, air‐leak syndrome (within 14 days), pneumothorax or pneumomediastinum. The following outcomes were reported in the manuscript but not in the protocol: mortality within 90 days, requirement for oxygen therapy more than 30% by 36 weeks' corrected gestational age, length of NICU stay. |
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Notes | Study was registered at ClinicalTrials.gov (Identifier: NCT02846597) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote "using internet based random table technique" |
Allocation concealment (selection bias) | Low risk | Quote "opaque sealed envelopes" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote "The clinical pathologist who performed the laboratory measures and the nursing staff responsible for the care of preterm infants in the NICU were blinded to groups of intervention". Not specified for the attending neonatologists |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All infants accounted for |
Selective reporting (reporting bias) | Low risk | All outcomes specified in the protocol were reported in the manuscript |
Other bias | Low risk | Appears free of other bias |