Meneses 2011.
Methods | Study design: randomized controlled prospective clinical trial Setting: single‐center study in Brazil Duration of study: 2007‐2009 |
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Participants | Inclusion criteria: infants from 26‐33 and 6/7 weeks' gestational age with clinical evidence of RDS Exclusion criteria: infants with major congenital anomalies, cardiovascular instability, intubation at admission to NICU, refusal of consent, or unavailability of ventilator Number randomized: 200 infants total (100 males, 100 females) |
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Interventions | Interventions were performed with the continuous‐flow neonatal ventilator and Bubble CPAP systems (InterMed Inc, São Paulo, Brazil) via binasal prongs. NCPAP (n = 100) was administered at 5‐6 cmH2O, and NIPPV (n = 100) was administered at PEEP 4‐6 cmH2O and PIP 15‐20 cmH2O with initial flow rate of 8‐10 L/min and rate of 20‐30 breaths/min. NIPPV was nonsynchronized. | |
Outcomes | Primary outcome: need for intubation in the first 72 hours of life Secondary outcomes: total duration of ETT ventilation, total duration on NCPAP, total duration on supplemental oxygen, pneumothorax, BPD, PDA, necrotizing enterocolitis, IVH (grade III/IV), ROP (≥ stage 3), time to full feeds, length of hospital stay |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number computer‐generated protocol |
Allocation concealment (selection bias) | Low risk | Sequentially numbered sealed opaque envelopes containing intervention assignments |
Blinding (performance bias and detection bias) All outcomes | High risk | Blinding was impossible owing to the nature of the interventions. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study authors reported no incomplete outcome data. |
Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes originally listed on ClinicalTrials.gov were the same as those reported in the published study. |
Other bias | Unclear risk | Unclear from information provided |