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Infant lung injury after bypass: scientists probe immune cell role

NCT ID NCT04296071

Knowledge-focused Sponsor: Sophia Koutsogiannaki 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study looks at why some infants develop lung injury after heart surgery that uses a heart-lung machine. Researchers will collect blood and fluid from the lungs of 56 babies under 1 year old to study how their immune cells (neutrophils) behave. The goal is to better understand the causes of this serious complication, not to test a new 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.

Participants

About 56 people

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

Started

Oct 2022

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.

Who is studied

We will enroll patients \< 12 months of age who undergo CPB surgery. This patient population is associated with the highest incidence of morbidity and mortality following cardiac surgery, due to often prolonged period of CPB. Patients will be categorized into two groups: Group 1: patients who tend to have longer CPB (\> 3 h), (ASO, Stage 1, IAA repair, Truncus repair, TAPVR) and Group 2: Patients who have shorter CPB (\< 3hrs VSD, TOF, ASD).

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: * Are \< 12months of age * Scheduled for cardiac surgical needing CPB * Preoperative SpO2 \> 90% Exclusion Criteria: * Lack of parental (or legal guardian's) consent * Preoperative SpO2 \< 90% * Preoperative oxygen therapy

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Conditions

The condition(s) this trial relates to.

acute lung injury Lung Injury

As listed by the trial registrant

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

Cardiopulmonary bypass Lung injury

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

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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