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RECRUITING
NCT05673499

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

Sponsor: Children's Hospital of Philadelphia

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 60 Weeks

Study Type

OBSERVATIONAL

Enrollment

900

Start Date

2022-08-12

Completion Date

2027-12-31

Last Updated

2025-04-17

Healthy Volunteers

Not specified

Interventions

DEVICE

NIRS/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