Biphasic positive airway pressure or continuous positive airway pressure: A randomized trial

TY - JOUR

T1 - Biphasic positive airway pressure or continuous positive airway pressure

T2 - A randomized trial

AU - Victor, Suresh

AU - Roberts, Stephen

AU - Mitchell, Simon

AU - Aziz, Huma

AU - Lavender, Tina

AU - Extubate Trial Group

PY - 2016/8

Y1 - 2016/8

N2 - 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.

AB - 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.

KW - Neonates

KW - PRETERM

KW - VENTILATED NEWBORN-INFANTS

KW - CPAP

KW - RANDOMIZED CLINICAL-TRIAL

U2 - 10.1542/peds.2015-4095

DO - 10.1542/peds.2015-4095

M3 - Article

SN - 0031-4005

VL - 138

JO - Pediatrics

JF - Pediatrics

IS - 2

M1 - e20154095

ER -