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New study tracks newborn brain health during surgery

NCT ID NCT05673499

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study monitors brain oxygen levels and electrical activity in 900 newborns undergoing surgery for birth defects. Using special sensors, researchers track changes before, during, and after surgery to understand when the brain may not get enough oxygen. The goal is to identify factors that lead to low brain oxygen and improve safety for future surgeries.

What this could mean

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

What this could lead to
If successful, this could help doctors better protect newborns' brains during surgery by identifying when oxygen levels drop and what causes it.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly change care yet. Results may not apply to all newborns or surgeries.

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 900 people

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

Started

Aug 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

Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformat

Ages

Up to 60 weeks

Sex

Anyone

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 ≤ 60 weeks post-menstrual age on day of surgery. 2. Neonatal surgery for congenital abdominal/gastrointestinal malformations (diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, necrotizing enterocolitis), congenital cystic adenomatoid/pulmonary airway malformation (CCAM/CPAM), esophageal/tracheoesophageal fistula (EF/TEF), and spinal malformations (myelomeningocele, sacrococcygeal teratoma). 3. The same patient may be enrolled multiple times for repeat or different procedures that meet the above criteria. These subjects will be counted more than once towards the enrollment goal. 4. Parental/guardian permission. Exclusion Criteria: 1\) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.

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Conditions

The condition(s) this trial relates to.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 7 countries. 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

  • Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants

    NOT_YET_RECRUITING

    Bordeaux, France

  • Children's Hospital at Montefiore/Albert Einstein College of Medicine

    NOT_YET_RECRUITING

    New York, New York, 10467, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Medical Center Dallas

    NOT_YET_RECRUITING

    Dallas, Texas, 75235, United States

  • Children's Memorial Hermann Hospital

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Christian Medical College Hospital

    NOT_YET_RECRUITING

    Vellore, India

  • Great Ormond Street Hospital for Children

    NOT_YET_RECRUITING

    London, United Kingdom

  • Guangzhou women and children's medical center

    NOT_YET_RECRUITING

    Guangzhou, China

  • Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo

    RECRUITING

    São Paulo, Brazil

  • Perth Children's Hospital

    RECRUITING

    Nedlands, Australia

  • Post Graduate Institute of Medical Education and Research

    NOT_YET_RECRUITING

    Chandigarh, India

  • Royal Children's Hospital

    NOT_YET_RECRUITING

    Parkville, Australia

  • Shanghai Children's Medical Center

    NOT_YET_RECRUITING

    Shanghai, China

  • Shengjing Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, China

  • West China Hospital and West China Second University Hospital

    NOT_YET_RECRUITING

    Sichuan, China

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