RecruitingOBSERVATIONAL

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

This study is investigating babies undergoing major surgery for birth defects. The main goal is to understand if their brain oxygen levels drop during the operation and whether this affects their recovery. Researchers will use two types of harmless monitors: NIRS, which measures oxygen in the brain, and EEG, which records brain electrical activity. These monitors will be placed on the baby's head before, during, and after surgery for up to 24 hours. The study aims to identify factors contributing to low brain oxygen and how it might relate to the baby's health outcomes, like their hospital stay and overall recovery. This information could help improve care for babies needing surgery.

At a glance

Status

Recruiting

Sponsor

Children's Hospital of Philadelphia

Enrolment target

900

Start

12 Aug 2022

Estimated completion

31 Dec 2027

Congenital Disorders Cerebral Desaturation Neonatal Surgery

What is this study about?

This study is designed to help us better understand what happens to a baby's brain during and immediately after major surgery for conditions they are born with. These conditions include various problems with the gut, lungs, or spine. The research team is particularly interested in brain oxygen levels and electrical activity during this critical time.

They want to find out how often a baby's brain might experience a temporary drop in oxygen (this is called 'cerebral desaturation') during an operation. By using special, gentle monitoring equipment, they can track these changes. The study will also look at whether these changes in brain oxygen are linked to other factors during surgery or how well the baby recovers afterwards, including their time in the hospital.

Understanding these connections could be really important. It might help doctors identify babies who are at higher risk and potentially lead to new ways to support and protect babies' brains during and after surgery, ultimately improving their overall care and long-term health.

Key takeaways

The study investigates brain oxygen during major surgery in newborns.
Gentle, non-invasive monitors (NIRS and EEG) are used on the baby's head.
Monitoring happens before, during, and up to 24 hours after surgery.
It aims to link brain oxygen levels to recovery and hospital outcomes.
Participation involves minimal risk and does not alter routine care.
Results could improve care for babies needing complex surgeries.

Who may be eligible?

This study is looking for newborn babies up to 60 weeks old (this is calculated from the start of their mother's last period, not just their birth date) who are having surgery for certain birth defects. These include problems with their tummy or gut (like a hole in the tummy wall, or issues with how the gut developed), certain lung conditions, problems with the tube connecting the mouth to the stomach, or issues with their spine.

A baby might be included if they need more than one surgery for these conditions. The most important thing is that a parent or legal guardian gives their permission for the baby to take part. However, some babies will not be able to join the study. This includes those with certain severe brain conditions, such as major bleeding in the brain or specific types of brain abnormalities that would interfere with the monitoring.

Quick self-check

Is your baby up to 60 weeks old (from the start of the last menstrual period)?
Is your baby having major surgery for a birth defect like gut, lung, or spinal issues?
Are you able to provide consent for your baby to participate?
Does your baby *not* have severe brain conditions like major brain bleeds or specific brain abnormalities?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your baby takes part in this study, they will have two types of special, harmless monitors placed on their head. These are called NIRS and EEG sensors. They feel gentle and don't involve needles or shots. These sensors will be put on about an hour before surgery and will stay on throughout the operation, and then for 8 to 24 hours after the surgery has finished. No extra anaesthetic or sedation will be needed for the monitoring before or after the operation.

These monitors work quietly in the background and will not affect the length of the surgery, the anaesthetic your baby receives, or their routine care. The medical team looking after your baby won't see the readings from these research monitors during the surgery, so they won't influence their immediate medical decisions. After the monitoring period, the sensors will be removed. The research team will also look at your baby's hospital notes up to 100 days after surgery, or until they leave the hospital, to understand their recovery and progress.

Potential risks and benefits

Participating in this study involves very little extra risk for your baby, as the monitoring devices are non-invasive and won't interfere with their medical care. There are no direct benefits to your baby from taking part, but the information gathered could significantly help future babies by improving our understanding of brain health during surgery. You are free to withdraw your baby from the study at any time without giving a reason, and this will not affect the quality of care they receive.

Locations (15)

Children's Hospital at Montefiore/Albert Einstein College of Medicine
New York, United States· Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, United States· Recruiting
Children's Medical Center Dallas
Dallas, United States· Not yet recruiting
Children's Memorial Hermann Hospital
Houston, United States· Not yet recruiting
Perth Children's Hospital
Nedlands, Australia· Recruiting
Royal Children's Hospital
Parkville, Australia· Not yet recruiting
Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
São Paulo, Brazil· Recruiting
Guangzhou women and children's medical center
Guangzhou, China· Not yet recruiting
Shanghai Children's Medical Center
Shanghai, China· Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, China· Not yet recruiting
West China Hospital and West China Second University Hospital
Sichuan, China· Not yet recruiting
Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants
Bordeaux, France· Not yet recruiting

+3 more sites — see the official record for the full list.

Common questions

What exactly will the monitors do?

The monitors will gently sit on your baby's head to measure how much oxygen is getting to their brain (NIRS) and to record their brain's electrical activity (EEG). They are painless and harmless.

Will my baby get extra medicine for this study?

No, your baby will not receive any additional anaesthetic or sedation specifically for this study. The monitoring happens during their planned surgery and recovery.

Will the study make my baby's surgery longer?

No, the monitoring will not extend the time your baby is under anaesthetic or the duration of their surgery. It runs alongside their normal care.

Can I remove my baby from the study if I change my mind?

Yes, you have the right to withdraw your baby from the study at any time, for any reason. Their medical care will not be affected.

How will this study help babies in the future?

By understanding brain oxygen levels during neonatal surgery, researchers hope to find better ways to protect babies' brains and improve their recovery after these important operations.

How to find out more

Paula Hu, RN, MSPH

hup@chop.edu 267-426-2961 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.