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Heart drug may shield tiny babies from deadly Post-Surgery syndrome

NCT ID NCT06679855

Prevention 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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 2 times

Summary

This study tests if the drug milrinone can prevent a serious heart complication called post-ligation cardiac syndrome (PLCS) in very preterm infants after surgery to close a heart vessel. About 316 babies born before 28 weeks will receive either milrinone or standard care. The goal is to see if milrinone reduces death or PLCS within a week and improves survival and brain development at age two.

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

About 316 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2029

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

Up to 3 months

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: * Gestational age at birth ≤27 weeks (and 6 days) and postnatal age \< 3 months at intervention * Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula) * Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention * Decision by clinical team to proceed with PDA closure via surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features of hemodynamic significance. Exclusion Criteria: * Any major congenital malformation * Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (\<3mm) atrial septal defect) * Acute renal failure defined by urine output \< 0.5 mL/kg/hour OR rise of serum creatinine by 0.3 mg/dL within 48 hours OR rise of serum creatinine more than 40% above baseline serum creatinine within prior 72 hours. * Systemic administration of vasodilator/inodilator agents * Prior history of arrhythmia

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Conditions

The condition(s) this trial relates to.

patent ductus arteriosus

As listed by the trial registrant

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

Post-ligation cardiac syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Case Western Reserve University

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Children's Hospital of Orange County

    NOT_YET_RECRUITING

    Orange, California, 92868, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Le Bonheur Children's Hospital

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • Northwestern Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Sharp Mary Birch Hospital for Women & Newborns

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • University of Alabama - Birmingham

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35249, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Mississippi Medical Center

    NOT_YET_RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of Oklahoma Health Sciences

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Texas at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.