Management of the PDA Trial — PDA  

Infant, Premature Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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). ;

Related Conditions & MeSH terms

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

• NCT number: NCT03456336
• Study type: Interventional
• Source: NICHD Neonatal Research Network
• Contact: Matthew Laughon, MD, MPH
• Phone: 984-974-5063
• Email: matt_laughon@med.unc.edu
• Status: Recruiting
• Phase: Phase 3
• Start date: December 3, 2018
• Completion date: March 2029