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Management of the PDA Trial

NCT03456336 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2026-05-12

Study results available
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Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • NICHD Neonatal Research Network

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
48 Hours
Max Age
21 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2025-03-02
Completion
2027-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03456336 on ClinicalTrials.gov