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. 2016 Dec 15;2016(12):CD005384. doi: 10.1002/14651858.CD005384.pub2

Meneses 2011.

Methods Study design: randomized controlled prospective clinical trial
Setting: single‐center study in Brazil
Duration of study: 2007‐2009
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)
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
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