Observational Study of Brain Oxygen and Electrical Activity During Neonatal Surgery

This study is looking at babies (neonates) who are having surgery for certain birth defects, such as problems with their abdomen, lungs, or esophagus. Researchers want to understand how often a baby's brain oxygen levels drop too low (cerebral desaturation) during and after surgery. They will use special monitors called NIRS (Near-infrared spectroscopy) and EEG (electroencephalogram) to measure brain oxygen and electrical activity. These monitors will be placed on your baby's head for about an hour before surgery, during the surgery itself, and for up to 24 hours afterward. The study aims to find out what factors might lead to low brain oxygen and how this relates to your baby's recovery and hospital stay. This is an observational study, meaning no new treatments are being tested, only monitoring is involved.

Study design
This is an observational study involving about 900 infants. It is not testing a new treatment, but rather monitoring brain activity and oxygen levels.
What's involved
Your baby will have NIRS and EEG sensors placed on their head for about an hour before surgery, during surgery, and for 8-24 hours after surgery. Medical records will also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
Medical record review will be conducted at 100 days post-operation or hospital discharge, whichever comes first.

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NCT05673499

International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

Recruiting
Not specifiedUp to 60Observational
Children's Hospital of Philadelphia
~900 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:NIRS/EEG monitoring

At a glance

Recruiting sites
3 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with perioperative cerebral desaturation
Measured over 24 hours
Congenital Disorders
Cerebral Desaturation
Neonatal Surgery
15 sites across 9 states
China4
Texas2
Australia2
India2
New York1
Pennsylvania1
Brazil1
France1
  • Charles Dean Kurth, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

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  • Percentage of participants with perioperative cerebral desaturation24 hours

    The incidence of cerebral desaturation in participants will be assessed by the Near-infrared Spectroscopy (NIRS) data recording of \<70% and/or \>10% decrease from baseline for \> 3 minutes