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Can a gas added to Heart-Lung machines shield Newborns' kidneys?

NCT ID NCT04216927

Prevention Sponsor: Children's Hospital Medical Center, Cincinnati 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether adding nitric oxide gas to the heart-lung machine during surgery can prevent acute kidney injury in newborns with congenital heart defects. Up to 60% of these babies experience kidney damage after surgery, which can lead to serious complications. The study will compare babies who receive nitric oxide during bypass with those who receive oxygen alone, monitoring for signs of kidney injury in the first 72 hours after surgery.

What this could mean

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

Active substance
Nitric oxide gas administered during cardiopulmonary bypass
What this could lead to
If effective, this simple addition to bypass could prevent acute kidney injury in newborns after heart surgery, reducing complications and improving recovery.
What could go wrong
This is a small, early-phase trial, and the benefit is not yet proven. Nitric oxide may not reduce kidney injury, and there are always risks with any intervention in fragile neonates.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 40 people

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

Started

Jan 2023

Expected to finish

Jun 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

1 day to 31 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 (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment. Exclusion Criteria: 1. Failure to obtain informed consent from parent/guardian 2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance, 3. Emergency surgery, 4. Episode of cardiac arrest within 1 week before surgery, 5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB), 6. Use of inhaled NO (iNO) immediately prior to surgery, 7. Structural renal abnormalities by ultrasound, 8. Preoperative AKI, 9. Use of other investigational drugs, 10. Weight less than \<2 kg, 11. Gestational age \<36 weeks, 12. Major extracardiac congenital anomalies, 13. Non-English speakers.

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Conditions

The condition(s) this trial relates to.

congenital heart disease acute kidney injury prevention target

As listed by the trial registrant

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

AKI CHD - congenital heart disease Surgery

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

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

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