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

April 12, 2024 updated by: Children's Hospital of Philadelphia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The NIRS EEG sensors will be placed about an hour before surgery. The recording will start once sensors are placed, continue throughout the duration of surgery, and end 8-24 hours after end of surgery. Sensors will be removed at the end of recording. No additional anesthesia and/or sedation will be required for the preoperative and postoperative recordings. The EEG and NIRS monitors will be blinded to clinical staff. EEG and NIRS monitoring will not prolong anesthesia or the duration of the surgical repair, and should not interfere with routine patient care. NIRS and EEG data will be downloaded from the monitors at the end of recording for analysis.

Medical record review will be conducted at 100 days postop or hospital discharge (whichever is sooner). The information below will be extracted:

  • Respiratory record
  • Post-op recovery, ICU, and discharge records
  • Cardiac and Neurologic records
  • Neurologic test such as radiology and lab tests
  • Mortality status

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Paula Hu, RN, MSPH
  • Phone Number: 267-426-2961
  • Email: hup@chop.edu

Study Contact Backup

Study Locations

  • Australia
      • Nedlands, Australia
      • Parkville, Australia
        • Not yet recruiting
        • Royal Children's Hospital
        • Contact:
  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
        • Contact:
  • China
      • Guangzhou, China
        • Not yet recruiting
        • Guangzhou Women and Children's Medical Center
        • Contact:
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Children's Medical Center
        • Contact:
      • Shenyang, China
        • Not yet recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
      • Sichuan, China
        • Not yet recruiting
        • West China Hospital and West China Second University Hospital
        • Contact:
  • France
      • Bordeaux, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants
        • Contact:
  • India
      • Chandigarh, India
        • Not yet recruiting
        • Post Graduate Institute of Medical Education and Research
        • Contact:
      • Vellore, India
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Great Ormond Street Hospital for Children
        • Contact:
  • United States
    • New York
      • New York, New York, United States, 10467
        • Not yet recruiting
        • Children's Hospital at Montefiore/Albert Einstein College of Medicine
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Children's Memorial Hermann Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformat

Description

Inclusion Criteria:

  1. Infants ≤ 60 weeks post-menstrual age on day of surgery.
  2. Neonatal surgery for congenital abdominal/gastrointestinal malformations (diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, necrotizing enterocolitis), congenital cystic adenomatoid/pulmonary airway malformation (CCAM/CPAM), esophageal/tracheoesophageal fistula (EF/TEF), and spinal malformations (myelomeningocele, sacrococcygeal teratoma).
  3. The same patient may be enrolled multiple times for repeat or different procedures that meet the above criteria. These subjects will be counted more than once towards the enrollment goal.
  4. Parental/guardian permission.

Exclusion Criteria:

1) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants
Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformations
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with perioperative cerebral desaturation
Time Frame: 24 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
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isoelectric EEG
Time Frame: up to 24 hours
Determined by EEG amplitude ≤ 10mV for ≥ 2 secs
up to 24 hours
Perioperative outcomes
Time Frame: up to 100 days
Medical record review
up to 100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

Masimo Corporation

Investigators

  • Principal Investigator: Ian Yuan, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-019679

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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