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Which breathing aid works best for tiny hearts after surgery?

NCT ID NCT05869825

Disease control Sponsor: Emory University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This study looks at 200 infants under 1 year old who had heart surgery for congenital heart disease. After their breathing tube is removed, they will get one of two standard breathing supports: High Flow Nasal Cannula or Non-Invasive Positive Pressure Ventilation. The goal is to see which method helps them breathe better and avoids needing the breathing tube again.

What this could mean

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

Active substance
High Flow Nasal Cannula (HFNC) and Non-Invasive Positive Pressure Ventilation (NIPPV)
What this could lead to
If this trial succeeds, it could identify which breathing support method is safer and more effective for infants recovering from heart surgery, potentially reducing the need for re-intubation.
What could go wrong
This is a relatively small, single-center study comparing two standard methods, so results may not apply to all hospitals or infants. The trial is not testing a new drug or cure, so the impact is limited to improving post-surgery care.

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 200 people

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

Started

Feb 2025

Expected to finish

Mar 2027

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

Up to 1 year

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: * All patients admitted to the CICU following cardiac surgery for CHD who are \</= 1 year of age and/or weight \</= 10 kg Exclusion Criteria: * Patients who remain intubated for \>/= 4 weeks * Patients who have a tracheostomy prior to their cardiac surgery * Patient enrolled in a competing research study * Patients requiring extracorporeal membrane oxygenation (ECMO) support preoperatively * Patients with birth weight \< 2 Kg. * Gestational age \< 35 weeks at birth. * Patients with extracardiac anomalies more than minor severity.

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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

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

  • Arthur M. Blank Hospital | Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

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