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New study weighs risks of treating vs. watching heart defect in preemies

NCT ID NCT03456336

Disease control Sponsor: NICHD Neonatal Research Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether actively treating a heart condition called patent ductus arteriosus (PDA) in premature babies is better than simply monitoring it. About 482 infants born between 22 and 28 weeks of pregnancy will be followed to see which approach reduces the risk of death or long-term lung problems. The goal is to help doctors make safer decisions for these fragile newborns.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

482 people

The number who actually took part.

Started

Feb 2019

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

48 hours to 21 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 on echocardiogram 2. Mild or Moderate Clinical Criteria with Large PDA on echocardiogram Exclusion Criteria: * Cardiopulmonary compromise * Known congenital heart disease (besides atrial septal defect or ventricular septal defect) * Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary adenomatous malformation) * Any condition which, in the opinion of the investigator, would preclude enrollment

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Conditions

The condition(s) this trial relates to.

Infant, Newborn, Diseases patent ductus arteriosus perinatal disease Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infant, newborn, diseases Infant, premature Patent ductus arteriosus Patent ductus arteriosus after premature birth

Contacts and locations

Locations

  • Brown University - Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905, United States

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

    Cleveland, Ohio, 44106, United States

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45267, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30303, United States

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • RTI International

    Durham, North Carolina, 27705, United States

  • Research Institute at Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

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

    Jackson, Mississippi, 39216, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

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