Use the Back button in your browser to see the other results of your search or to select another record.
Biphasic positive airway pressure or continuous positive airway pressure: a randomized trial [with consumer summary] |
Victor S, Roberts SA, Mitchell S, Aziz H, Lavender T, on behalf of the Extubate Trial Group |
Pediatrics 2016 Aug;138(2):e20154095 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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 to 1.56; p = 0.97). 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.
|