Schmölzer 2018.
Methods | Prospective randomised parallel controlled trial Pilot (5 infants randomised to each group) Setting: Royal Alexandra Hospital, Edmonton, Alberta, Canada |
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Participants | Inclusion criteria: inborn infants between 23+0 and 32+6 weeks of postmenstrual age who required chest compressions in the delivery room Exclusion criteria: congenital abnormality or condition that might have an adverse effect on breathing or ventilation (e.g. congenital pulmonary or airway anomalies, congenital diaphragmatic hernia, congenital heart disease requiring intervention in neonatal period) |
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Interventions |
Default settings for airway pressures: PIP of 24 cmH₂O and PEEP of 6 cmH₂O |
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Outcomes | Primary outcome: return of spontaneous circulation Secondary outcomes (we obtained the following information directly from trial authors): all mortality before discharge from hospital, delivery room interventions (rate of intubation, use of epinephrine), mechanical ventilation, use of inotropic agents, NEC, moderate to severe BPD, ROP, brain injury as indicated by abnormal neuroimaging |
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Notes | Trial was registered at ClinicalTrials.gov: NCT02083705 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Low risk | A sequentially numbered, brown, sealed envelope contained a folded card box with treatment allocation |
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 | Both data collector and outcome assessor were unaware of group allocation |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not reported |
Selective reporting (reporting bias) | High risk | Trial was registered at ClinicalTrials.gov: NCT02083705. However, secondary outcomes were not specified |
Other bias | Low risk | Appears free of other bias |