NCT03456336

Management of the PDA Trial

Management of the Patent Ductus Arteriosus in Premature Infants Trial (PDA Trial)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 836 (estimated)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 48 Hours – 21 Days
• Healthy volunteers: Not accepted

Summary

Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.

Detailed description

This is a pragmatic randomized multicenter, effectiveness study comparing active treatment of a symptomatic patent ductus arteriosus (sPDA) to expectant management. We hypothesize in premature infants with a sPDA, expectant management reduces the incidence proportion of death or BPD by 10% (from 50% to 40%) when compared to active treatment. Participants with a sPDA allocated to the active treatment arm will receive intravenous administration of indomethacin or ibuprofen (depending on center preference). The decision to ligate 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's discretion and will receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise. The decision to ligate 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).

Conditions

• Infant, Premature
• Patent Ductus Arteriosus
• Infant, Newborn, Diseases
• Patent Ductus Arteriosus After Premature Birth

Interventions

Type	Name	Description
OTHER	Active Treatment	Infants assigned to the active treatment group will receive indomethacin or ibuprofen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other. If the infant receives both, it will be considered a protocol violation.
OTHER	Expectant Management	Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.

Timeline

• Start date: 2019-02-22
• Primary completion: 2025-03-02
• Completion: 2027-05-30
• First posted: 2018-03-07
• Last updated: 2025-09-15

Locations

19 sites across 1 country: United States