New study tracks newborn brain health during surgery
NCT ID NCT05673499
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
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About 900 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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Up to 60 weeks
- Sex
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Anyone
Show the full entry requirements Hide 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.
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.
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The places running it
15 sites in 7 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants
NOT_YET_RECRUITINGBordeaux, France
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Children's Hospital at Montefiore/Albert Einstein College of Medicine
NOT_YET_RECRUITINGNew York, New York, 10467, United States
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Children's Medical Center Dallas
NOT_YET_RECRUITINGDallas, Texas, 75235, United States
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Children's Memorial Hermann Hospital
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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Christian Medical College Hospital
NOT_YET_RECRUITINGVellore, India
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Great Ormond Street Hospital for Children
NOT_YET_RECRUITINGLondon, United Kingdom
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Guangzhou women and children's medical center
NOT_YET_RECRUITINGGuangzhou, China
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Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
RECRUITINGSão Paulo, Brazil
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Perth Children's Hospital
RECRUITINGNedlands, Australia
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Post Graduate Institute of Medical Education and Research
NOT_YET_RECRUITINGChandigarh, India
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Royal Children's Hospital
NOT_YET_RECRUITINGParkville, Australia
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Shanghai Children's Medical Center
NOT_YET_RECRUITINGShanghai, China
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Shengjing Hospital of China Medical University
NOT_YET_RECRUITINGShenyang, China
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West China Hospital and West China Second University Hospital
NOT_YET_RECRUITINGSichuan, China
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