Management of the PDA Trial

Last updated: January 28, 2025
Sponsor: NICHD Neonatal Research Network
Overall Status: Active - Not Recruiting

Phase

3

Condition

Heart Defect

Treatment

Expectant Management

Active Treatment

Clinical Study ID

NCT03456336
NICHD-NRN-0059
UG1HD112079
UG1HD112100
UG1HD112097
  • Ages 48-21
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Postnatal age 48 hours -21 days

  • Infant 22 0/7 to 28 6/7 weeks gestation at birth

  • sPDA, as defined as:

  1. Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA onechocardiogram

  2. Mild or Moderate Clinical Criteria with Large PDA on echocardiogram

Exclusion

Exclusion Criteria:

  • Cardiopulmonary compromise

  • Known congenital heart disease (besides atrial septal defect or ventricular septaldefect)

  • Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonaryadenomatous malformation)

  • Any condition which, in the opinion of the investigator, would preclude enrollment

Study Design

Total Participants: 836
Treatment Group(s): 2
Primary Treatment: Expectant Management
Phase: 3
Study Start date:
February 22, 2019
Estimated Completion Date:
May 30, 2027

Study 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).

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California 92123
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Mississippi Medical Center - Children's of Mississippi

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • RTI International

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Case Western Reserve University, Rainbow Babies and Children's Hospital

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Research Institute at Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Brown University - Women and Infants Hospital of Rhode Island

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75235
    United States

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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