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Biphasic Positive Airway Pressure or Continuous Positive Airway Pressure: A Randomized Trial
Suresh Victor1, Stephen A Roberts2, Simon Mitchell3
1Newborn ICU, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Sciences Centre, School of Biomedicine, Neonatology Center of Excellence, Sidra Medical and Research Center, Doha, Qatar; and suresh.victor@kcl.ac.uk.
Background:
There is currently no clear evidence that nasal-biphasic positive airway pressure (n-BiPAP) confers any advantage over nasal-continuous positive airway pressure (n-CPAP). Our hypothesis was that preterm infants born before 30 weeks' gestation and <2 weeks old when extubated onto n-BiPAP will have a lower risk of extubation failure than infants extubated onto n-CPAP at equivalent mean airway pressure.
Methods:
We conducted an unblinded multicenter randomized trial comparing n-CPAP with n-BiPAP in infants born <30 weeks' gestation and <2 weeks old. The primary outcome variable was the rate of extubation failure within 48 hours after the first attempt at extubation. Block randomization stratified by center and gestation (<28 weeks or ≥28 weeks) was performed.
Results:
A total of 540 infants (270 in each group) were eligible to be included in the statistical analysis; 57 (21%) of n-BiPAP group and 55 (20%) of n-CPAP group failed extubation at 48 hours postextubation (adjusted odds ratio 1.01; 95% confidence interval 0.65-1.56; P = .97). Subgroup analysis of infants born before and after 28 weeks' gestation showed no significant differences between the 2 groups. There were no significant differences between arms in death; oxygen requirement at 28 days; oxygen requirement at 36 weeks' corrected gestation; or intraventricular hemorrhage, necrotizing enterocolitis requiring surgery, or pneumothorax.
Conclusions:
This trial shows that there is no added benefit to using n-BIPAP over n-CPAP at equivalent mean airway pressure in preventing extubation failures in infants born before 30 weeks' gestation and <2 weeks old.
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