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Can a simple steroid help babies recover faster from heart surgery?

NCT ID NCT03229538

Disease control Sponsor: Kevin Hill 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether giving the steroid methylprednisolone before and during heart surgery could reduce dangerous inflammation in infants under one year old. Over 1,200 babies were randomly assigned to receive either the steroid or a placebo (salt water). Researchers tracked complications, length of hospital stay, and survival to see if the steroid made a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methylprednisolone (a steroid)
What this could lead to
If it works, this could reduce serious complications and shorten hospital stays for infants after heart surgery.
What could go wrong
This is a completed phase 3 trial, but steroids may not improve outcomes and could carry risks like infection or side effects. Results may not apply to all infants.

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

1,263 people

The number who actually took part.

Started

Oct 2017

Finished

Mar 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Up to 12 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: * Age \< 1 year at the time of surgery * Undergoing heart surgery with CPB as part of standard clinical care * Availability and willingness of the parent/legally authorized representative to provide written informed consent Exclusion Criteria: * \< 37 weeks adjusted gestational age at time of surgery * Any oral or intravenous steroid treatment within two days of surgery * Any patient receiving any of the following medications within 2 days of surgery: Amphotericin B, aminoglutethimide, anticholinesterases, warfarin, P450 3A4 inducers including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, bosentan and nafcillin or P450 3A4 inhibitors including (but not limited to) clarithromycin, voriconazole, itraconazole, ketoconazole, ciprofloxacin, diltiazem, fluconazole, erythromycin and verapamil. * Infection contraindicating steroid use * Preoperative mechanical circulatory support or active resuscitation at the time of randomization * Emergent surgery precluding steroid administration 8-12 hours before surgery

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Conditions

The condition(s) this trial relates to.

congenital heart disease inflammatory disease

As listed by the trial registrant

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

Congenital heart disease in children Inflammatory response

Contacts and locations

Locations

  • Advocate Children's Hospital

    Oak Lawn, Illinois, 60453, United States

  • Ann & Robert Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611-2605, United States

  • Baylor College of Medicine, Texas Children's Hospital

    Houston, Texas, 77030, United States

  • Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039, United States

  • Children's Hospital and Clinics of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Children's Hospital and Medical Center

    Omaha, Nebraska, 68114, United States

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Morgan Stanley Children's Hospital of New York Presbyterian

    New York, New York, 10032-3702, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9020, United States

  • University of Colorado, Denver

    Aurora, Colorado, 80045, United States

  • University of Florida Health - Shands Hospital

    Gainesville, Florida, 32608, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • Utah/Primary Children's Medical Center

    Salt Lake City, Utah, 84113, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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