RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-12
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05673499

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.

Ages Eligible for Study:Not specified to 60 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Infants ≤ 60 weeks post-menstrual age on day of surgery.
  2. 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. 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. 4. Parental/guardian permission.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Paula Hu, RN, MSPH
CONTACT
267-426-2961
hup@chop.edu
Elizabeth Ramsay
CONTACT
267-270-5087
ramsaye2@chop.edu

Principal Investigator

Ian Yuan, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital at Montefiore/Albert Einstein College of Medicine
New York, New York, 10467
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Medical Center Dallas
Dallas, Texas, 75235
United States
Children's Memorial Hermann Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Ian Yuan, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

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 Registration Dates

Study Start Date2022-08-12
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-08-12
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Electroencephalography
  • Near-infrared spectroscopy

Additional Relevant MeSH Terms

  • Congenital Disorders
  • Cerebral Desaturation
  • Neonatal Surgery