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Could a common numbing drug shield Babies' lungs after heart surgery?

NCT ID NCT07499154

Disease control Sponsor: The Children's Hospital of Zhejiang University School of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This study tests whether giving the numbing drug lidocaine during heart surgery can reduce lung damage in infants. 320 babies under 1 year old having heart surgery will receive either lidocaine or a placebo. The goal is to see if lidocaine lowers the severity of lung injury 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
lidocaine
What this could lead to
If it works, this could provide a simple, low-cost way to protect infants' lungs after heart surgery, reducing time on a ventilator and in the ICU.
What could go wrong
This is a Phase 4 trial, but lidocaine is already used for other purposes. The benefit for lung injury is not proven, and there is a risk of side effects like heart rhythm problems.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 320 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 12 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 aged 0 to 12 months. 2. Congenital heart disease requiring corrective, non-palliative cardiac surgery with cardiopulmonary bypass. 3. American Society of Anesthesiologists (ASA) physical status I to III. 4. Written informed consent provided by parent(s) or legal guardian(s). Exclusion Criteria: 1. Multiple malformations, chromosomal abnormalities, or immunodeficiency. 2. Known or suspected allergy to lidocaine. 3. Concomitant continuous infusion of another local anesthetic. 4. Conditions associated with increased risk of lidocaine accumulation or toxicity, including severe conduction block or severe bradycardia. 5. ASA physical status IV or higher. 6. Severe malnutrition expected to substantially impair postoperative recovery. 7. Severe hepatic or renal dysfunction. 8. Significant pre-existing pulmonary disease or markedly impaired preoperative pulmonary function. 9. Central nervous system disorders that may increase susceptibility to lidocaine neurotoxicity, including epilepsy or prior central nervous system infection. 10. Use of medications that may interact with lidocaine or constitute an exclusion, including class I or class III antiarrhythmic agents, cimetidine, or antiviral drugs, as determined by the clinical team. 11. Current or recent participation in another interventional clinical trial in its active intervention phase.

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Conditions

The condition(s) this trial relates to.

acute lung injury congenital heart disease Lung Injury

As listed by the trial registrant

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

Acute lung injury Congenital heart disease Postoperative pulmonary complications

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

  • Children's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052, China

More trials for these conditions

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