RecruitingNCT05673499

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


Sponsor

Children's Hospital of Philadelphia

Enrollment

900 participants

Start Date

Aug 12, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are: 1. The perioperative factors associated with occurrence of cerebral desaturation 2. The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions. Participants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.


Eligibility

Max Age: 60 Weeks

Plain Language Summary

Simplified for easier understanding

This international study monitors brain oxygen levels and electrical activity in newborns undergoing major surgery for congenital conditions — including diaphragmatic hernia, gastroschisis, bowel problems, and spinal defects. Surgery in newborns carries risks of brain injury. By attaching non-invasive brain monitors during surgery, researchers aim to detect early signs of brain stress and find ways to protect newborn brains during these procedures. **You may be eligible if...** - Your baby is 60 weeks postmenstrual age or younger at the time of surgery - Your baby is undergoing neonatal surgery for a listed congenital condition (including diaphragmatic hernia, gastroschisis, intestinal atresia, esophageal fistula, or spina bifida) - Parents or guardians have given permission **You may NOT be eligible if...** - Your baby has hydrocephalus limiting the frontal-parietal brain area, severe brain bleeding (grade 3 or 4), brain malformation, or cerebral infarction in the area where monitoring sensors are placed **Talk to your neonatologist or neonatal surgeon if** your newborn is scheduled for surgery and you want to know about brain monitoring research during the procedure.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICENIRS/EEG monitoring

The study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.


Locations(15)

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

New York, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Children's Memorial Hermann Hospital

Houston, Texas, United States

Perth Children's Hospital

Nedlands, Australia

Royal Children's Hospital

Parkville, Australia

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

São Paulo, Brazil

Guangzhou women and children's medical center

Guangzhou, China

Shanghai Children's Medical Center

Shanghai, China

Shengjing Hospital of China Medical University

Shenyang, China

West China Hospital and West China Second University Hospital

Sichuan, China

Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants

Bordeaux, France

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Christian Medical College Hospital

Vellore, India

Great Ormond Street Hospital for Children

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05673499


Related Trials