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. 2023 Mar 31;2023(3):CD015130. doi: 10.1002/14651858.CD015130

Jazexhiu‐Postoli 2015.

Study characteristics
Methods RCT
Participants 200 newborn infants (28 to 35 weeks' gestation) with respiratory distress up to 6 hours after birth treated with CPAP 6 cm H₂O (as primary support)
Interventions Bubble (Fisher & Paykel): N = 100
Infant Flow Driver (biphasic): N = 100
Short binasal prongs were used in both groups.
Outcomes CPAP failure (need for mechanical ventilation)
Death before discharge
Duration of CPAP use
Pneumothorax
Duration of hospitalisation (intensive care)
Intraventricular haemorrhage (grade I to IV)
Patent ductus arteriosus
"Nasal lesions"
Notes Setting: Tirana, Albania (2011 to 2013)
Funding: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated (corresponding author contacted September 2021)
Allocation concealment (selection bias) Unclear risk Not stated (corresponding author contacted September 2021)
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 Unclear risk Baseline characteristics data not reported.