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Can a new guideline help mothers breastfeed babies with heart defects?

NCT ID NCT07582848

Knowledge-focused Sponsor: Carelon Research 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests a special breastfeeding guideline for infants born with congenital heart disease (CHD). Researchers want to see if the guideline helps more mothers breastfeed directly and reduces stress. About 266 mother-infant pairs will take part across multiple hospitals, with some hospitals using the new guideline and others providing usual care.

What this could mean

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

Active substance
breastfeeding clinical practice guideline
What this could lead to
If successful, this could provide a proven approach to help more mothers directly breastfeed infants with congenital heart disease, potentially improving health outcomes for both.
What could go wrong
This is a behavioral intervention study, not a drug trial, so results may vary by hospital and family adherence. The study hasn't started yet, and benefits are uncertain.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 266 people

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

Started

Jul 2026

Expected to finish

Aug 2030

An estimate. End dates often move.

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

18 years and older

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.

Both mothers and infants are study participants. Inclusion criteria: 1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period. 2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life. 3. Admission to the ICU (either CICU or NICU) at participating center in 1st week of life and for whom cardiac surgical or transcatheter intervention is anticipated in the first 30 days of life. 4. Willing to comply with protocol and provide written informed consent Exclusion Criteria: 1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation. 2. Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial. 3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent. 4. Infant birthweight \<3rd percentile for gestational age 5. Infant gestational age \< 36 weeks 6. Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate 7. Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

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

Congenital heart disease (CHD)

How to take part

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

  1. The places running it

    17 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

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Los Angeles

    NOT_YET_RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of New York

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Children's Mercy Hospital

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Golisano Children's at UK

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40502, United States

  • Icahn School of Medicine at Mount Sinai

    NOT_YET_RECRUITING

    New York, New York, 10029, United States

  • Le Bonheur Children's Hospital

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • Lurie Children's Hospital

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Phoenix Children's Hospital

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85016, United States

  • Primary Children's Medical Center

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84113, United States

  • University of Michigan Health System, Ann Arbor

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Washington University School of Medicine

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

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