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Design: Unblinded multicentre randomised trial.
Allocation: Web-based block randomisation stratified by centre and gestation, either above or below 28 weeks.
Setting: Eight neonatal intensive care units in the northwest of England.
Patients: Five hundred forty-four infants born before 30 weeks’ gestation and aged less than 2 weeks old were randomised at first extubation attempt to nasal continuous positive airway pressure (nCPAP) (272 infants) or nasal biphasic positive airway pressure (nBiPAP) (272 infants). Two infants per arm were excluded after randomisation as they did not meet the eligibility criteria. All received surfactant postintubation. Infants with major congenital malformations, upper respiratory tract abnormalities, neuromuscular disease, significant cranial ultrasound abnormalities and those extubated within 7 days of laparoscopy were excluded from the study. All infants were required to be loaded with caffeine and show respiratory effort persistently above the ventilator rate and satisfactory blood gases on minimal ventilation prior to extubation.
Intervention: Participants were randomised between extubation to nBiPAP or nCPAP at equivalent mean airway pressures (MAPs) of 6 cm H2O. For biphasic positive airway pressure (BiPAP), that was a baseline pressure of 4 cm H2O, peak 8 cm H2O, I-time of 1 s and a rate of 30. After 48 hours of stability, MAP was weaned by 1 cm H2O per 48 hours until a MAP of 4 cm H2O was reached. Time off pressure support was allowed once 4 cm H2O was reached, and no fixed weaning regime was followed.
Outcomes: The primary outcome measure was extubation failure in the first 48 hours postextubation. No crossover was allowed, and rescue treatment was provided by increasing MAP pressure back to 6 cm H2O or by reintubation.
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