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New blood pressure strategy aims to protect newborns during heart surgery

NCT ID NCT07221721

Disease control Sponsor: Jennie E Minnich Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Updated 2 times

Summary

This pilot study tests whether actively managing blood pressure during heart surgery in newborns can reduce dangerous low blood pressure episodes. About 130 newborns will be randomly assigned to either standard care or a new approach using a special monitor to keep blood pressure above a safe level. The goal is to see if this method is feasible and safe.

What this could mean

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

Active substance
Active mean arterial pressure (MAP) management using a novel autoregulation monitoring device
What this could lead to
If successful, this approach could reduce the risk of low blood pressure during and after heart surgery in newborns, potentially improving outcomes.
What could go wrong
This is a small, early pilot study, so results may not be conclusive. The monitoring device is new and may not work as expected in all cases.

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.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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

30 to 30 days

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 neonates (\<30 days of age) * Undergoing cardiothoracic surgery with cardiopulmonary bypass Exclusion Criteria: * Less than full term (\<37 weeks gestation) * Weight \< 2.50kg * Genetic abnormality or syndrome except heterotaxy syndrome * Major non-cardiac anomalies (e.g. congenital diaphragmatic hernia, - omphalocele, holoprosencephaly, anencephaly)

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Conditions

The condition(s) this trial relates to.

congenital heart disease hypotensive disorder

As listed by the trial registrant

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

Hypotension during surgery Hypotension postprocedural

Contacts and locations

Locations

  • The Cleveland Clinic

    Cleveland, Ohio, 44195, United States

More trials for these conditions

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