Bhatti 2015.
Study characteristics | ||
Methods | RCT | |
Participants | 170 preterm neonates (< 34 weeks') with respiratory distress within 6 hours after birth treated with CPAP 5 to 7 cm H₂O (as primary support) | |
Interventions | Bubble ("stand‐alone" system with Fisher & Paykel interface): N = 90 Ventilator (Jet‐CPAP, Phoenix Medical Systems): N = 80 Short binasal prongs were the nasal interface. |
|
Outcomes | CPAP failure within 72 hours (persistent hypoxia with FiO₂ > 0.6 requiring endotracheal intubation and mechanical ventilation or nasal intermittent positive pressure ventilation) Receipt of surfactant Death before discharge Duration of CPAP use Pneumothorax Bronchopulmonary dysplasia Retinopathy of prematurity Intraventricular haemorrhage (grade II to IV) Necrotising enterocolitis Nasal trauma (moderate‐severe as per "Nasal Injury Score") |
|
Notes | Setting: Chandigarh, India (2011 to 2012) Funding: not stated |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated ("web‐based") |
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 |