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Special baby formula may boost growth in heart defect infants

NCT ID NCT07087782

Disease control Sponsor: Driscoll Children's Hospital Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a high-calorie formula called Fortini helps babies born with a serious heart condition (single ventricle) grow better after their first heart surgery. About 100 infants will be randomly assigned to receive either Fortini or standard high-calorie formula after leaving the hospital. Researchers will track weight gain, feeding tolerance, and hospital readmissions until the babies' next surgery, aiming to improve nutrition and reduce stress for families.

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 100 people

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

Started

Jul 2025

Expected to finish

Jun 2029

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

0 to 6 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: 1. Infants with single ventricle physiology who have undergone Stage 1 surgical palliation (e.g., Norwood, hybrid, or BT shunt) 2. Medically stable and ready for discharge from the hospital 3. Feeding via oral, nasogastric (NG), or gastrostomy tube 4. Age \< or = 6 months at time of discharge 5. Parent or legal guardian able to provide informed consent Exclusion Criteria: 1. Preexisting gastrointestinal condition contraindicating formula use (e.g. NEC, short gut, malabsorption) 2. Contraindication to Fortini (e.g. proven cow's milk protein allergy) 3. Current enrollment in another interventional feeding or nutrition study 4. Social circumstances likely to preclude safe outpatient follow up

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Conditions

The condition(s) this trial relates to.

univentricular cardiopathy univentricular heart

As listed by the trial registrant

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

Single-ventricle

How to take part

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

  1. The places running it

    1 site. 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

  • Driscoll Children's Hospital

    RECRUITING

    Corpus Christi, Texas, 78411, United States

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