Armanian 2014.
Methods | Study design: single‐center RCT Setting: tertiary NICU Duration: March 2013 to January 2014 |
|
Participants | Infants with birth weight ≤ 1500 grams and/or gestational age ≤ 34 weeks with respiratory distress, including x‐ray diagnosis. Infants with major congenital anomalies, asphyxia, cyanotic heart defects, cardiovascular instability, and orofacial anomalies were excluded. | |
Interventions | NIPPV was provided by a ventilator (exact ventilator not specified) and short binasal prongs. Settings: rate 40‐50, PIP 16‐20 cmH2O, PEEP 5‐6 cmH2O; nonsynchronized CPAP was provided via bubble CPAP, 5‐6 cmH2O. |
|
Outcomes | Primary outcomes: need for intubation due to respiratory failure (defined) within 48 hours of life, duration of noninvasive respiratory support Secondary outcomes: need for INSURE, oxygen days, chronic lung disease, length of hospital stay, air leaks |
|
Notes | IRCT2014021410026N4; quasi‐randomized trial | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Assigned by "file" number |
Allocation concealment (selection bias) | High risk | |
Blinding (performance bias and detection bias) All outcomes | High risk | Intervention cannot be blinded. All outcomes with the exception of long‐term follow‐up would be potentially biased. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3/98 lost to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Stated secondary outcome of need for INSURE surfactant treatment; chronic lung disease not reported |