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Could early heart support protect Brain-Injured newborns?

NCT ID NCT07406477

Disease control Sponsor: University of Alberta 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

Some newborns with HIE, a brain injury from lack of oxygen at birth, also develop heart problems. This pilot trial tests whether starting a heart medication called dobutamine early, before heart failure signs appear, is feasible and safe. Forty babies receiving cooling therapy will be randomly assigned to early dobutamine or a placebo. The goal is to see if this approach can be reliably done and to gather initial data for a larger future study.

What this could mean

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

Active substance
Dobutamine
What this could lead to
If this pilot succeeds, it could lead to a larger trial that may show early heart support improves outcomes for babies with HIE.
What could go wrong
This is a very small, early-phase pilot study with only 40 babies. It is designed to test feasibility, not effectiveness, so it may not lead to a proven treatment.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 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

1 to 1 day

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: * Newborns with hypoxemic ischemic encephalopathy (HIE) receiving therapeutic hypothermia (TH). Exclusion Criteria: 1. Congenital abnormality 2. known contraindication of dobutamine * Left ventricular outflow tract dynamic obstruction * Hypersensitivity to dobutamine * Uncorrected tachyarrhythmias or ventricular fibrillation 3. Newborns who are already started on inotropes at the time of randomization. 4. Parental refusal to consent to participate

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia perinatal asphyxia

As listed by the trial registrant

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

Hypoxic-ischemic encephalopathy (HIE)

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

  • Royal Alexandra Hospital

    Edmonton, Alberta, Canada

More trials for these conditions

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