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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
At a glance
Conditions
Where it's being run
15 sites across 9 statesStudy leadership
- Charles Dean Kurth, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
Who to contact
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What this trial measures
- 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