CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 482 enrolled
Drug / intervention
Active Treatment +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03456336
NCT03456336Phase 3Active
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Management of the Patent Ductus Arteriosus in Premature Infants Trial (PDA Trial)

NICHD Neonatal Research Network·interventional·Posted Mar 7, 2018·Updated May 12, 2026

In Brief

A Phase 3 clinical trial evaluating Active Treatment and Expectant Management for Infant, Premature and 3 related conditions. Active but no longer recruiting, targeting 482 participants across 19 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Premature, Patent Ductus Arteriosus, Infant, Newborn, Diseases, Patent Ductus Arteriosus After Premature Birth
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3Active
2018201920202021202220232024202520262027
First PostedMar 7, 2018
Enrollment StartFeb 22, 2019
Primary CompletionMar 2, 2025
Study CompletionMay 30, 2027
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 8.3 years ago

Interventions

Active Treatmentother

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.

Expectant Managementother

Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.