NICHD Neonatal Research Network
The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at 36 weeks' PMA.
Inclusion Criteria: * Gestational age \<29 weeks at birth * PMA \<32 weeks at study entry * On treatment with CPAP without a rate in FiO2 \<0.25 and PEEP of 4-5 cmH2O * Meet stability criteria: * If previously intubated must be extubated ≥ 72 hours * \<3 self-resolving apneas (≤ 20 s) and/or bradycardia (\<100 bpm) in any hour over previous 6 hours * No episodes of apnea or bradycardia requiring intervention (oxygen/stimulation/bag and mask) for 24 hours * Parents/legal guardians consent for enrollment Exclusion Criteria: * Major malformation * Neuromuscular condition that affects respirati…
Prior to study entry, the CPAP interface (includes RAM cannula, Optiflow, large bore cannulas, mask, prongs) and mode (bubble, variable-flow, ventilator-derived) used is at the discretion of the provider and center. After study entry, CPAP will be provided via mask or binasal prongs to maintain a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery whenever available.
HFNC at 4 L/min will be used initially in the control group. Flow should be titrated down by 1 L/min per day until ≤0.5 L/kg among infants in the nasal cannula group if not meeting pre-specified failure criteria to reduce the risk of inadvertent positive end-expiratory pressure (PEEP). Flow can also be increased (up to 6 L/min maximum) if needed among infants on NC who meet the pre-specified failure criteria. Infants in the control group placed back on CPAP may use an interface at provider discretion.