Mazmanyan 2016.
Study characteristics | ||
Methods | RCT | |
Participants | 125 preterm neonates (< 37 weeks') with respiratory distress treated with nasal CPAP 4 to 6 cm H₂O (as primary support) | |
Interventions | Bubble (Fisher & Paykel): N = 66 Infant Flow Driver: N = 59 Short binasal prongs were used for Infant Flow Driver CPAP, and pliable long anatomically curved prongs for bubble CPAP. |
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Outcomes | CPAP failure (receipt of mechanical ventilation) Death before discharge Duration of CPAP use Duration of supplemental oxygen Pneumothorax Nasal injury (excoriation) Retinopathy of prematurity Periventricular haemorrhage/leucomalacia Necrotising enterocolitis |
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Notes | Setting: Yerevan, Armenia (2012 to 2014) Funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Low risk | Serially numbered, sealed, and opaque envelopes |
Blinding (performance bias and detection bias) All outcomes | High risk | Open‐label |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome reporting complete. |
Selective reporting (reporting bias) | Low risk | Unlikely (comprehensive) |
Other bias | Low risk | No evidence of an imbalance in baseline demographics |