Management of the Patent Ductus Arteriosus in Premature Infants (PDA Trial)
Study ID: STU-2019-0784
Summary
sPDA and cardiopulmonary compromise will be defined by this protocol, requiring both clinical and echocardiographic evidence. Participants with a sPDA allocated to the active treatment arm will receive intravenous administration of indomethacin or ibuprofen (depending on center preference). The decision for further treatment (e.g., ligation or cardiac catheterization) will be left to the clinical team. Participants with a sPDA allocated to the expectant management arm will receive supportive care at the clinical team[Single Quote]s discretion and will receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise. The decision for further treatment (e.g., ligation or cardiac catheterization) will be left to the clinical team. The primary endpoint for the study will be death or BPD (as assessed by the physiologic definition) at 36 weeks postmenstrual age (PMA). Secondary outcomes will be death and Bronchopulmonary Dysplasia(BPD) (separately), sever[See protocol for complete text]
This is a pragmatic randomized multicenter, effectiveness study comparing active treatment of a sPDA (symptomatic patent ductus arteriosus) to expectant management.