Suresh Victor1, Stephen A Roberts2, Simon Mitchell3, Huma Aziz4, Tina Lavender5. 1. Newborn 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. 2. Centre for Biostatistics, and. 3. Newborn ICU, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Sciences Centre, School of Biomedicine, College of Health and Social Care, University of Salford, Manchester, United Kingdom. 4. Newborn ICU, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Sciences Centre, School of Biomedicine. 5. School of Nursing, Midwifery, and Social Work, University of Manchester, Manchester, United Kingdom;
Abstract
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.
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.
Authors: Leeann R Pavlek; Brian K Rivera; Charles V Smith; Joanie Randle; Cory Hanlon; Kristi Small; Edward F Bell; Matthew A Rysavy; Sara Conroy; Carl H Backes Journal: J Pediatr Date: 2021-04-21 Impact factor: 6.314