24-hour and 30-day perioperative mortality in pediatric surgery.
Patrick C Bonasso, M Sidney Dassinger, Mark L Ryan...
https://pubmed.ncbi.nlm.nih.gov/30017066Actively Recruiting
Age: 0 - 60Weeks
All Genders
ID05673499
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
Led by Children's Hospital of Philadelphia · Updated on 2026-04-23
900
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
M
Masimo Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This observational study focuses on infants undergoing surgery for congenital malformations to understand how often cerebral desaturation occurs around the time of surgery. It aims to identify factors linked to cerebral desaturation and how this condition relates to outcomes during and after surgery. The study is particularly interested in infants up to 60 weeks post-menstrual age undergoing neonatal surgery for conditions such as diaphragmatic hernia and intestinal atresia. Participants will have Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) sensors placed about an hour before surgery. Monitoring starts when the sensors are placed, continues throughout surgery, and lasts up to 8 to 24 hours after surgery. These sensors will be removed after the monitoring period. The monitoring does not require extra anesthesia or sedation, will not extend surgery time, and the data collected will be blinded to clinical staff. During the study, medical records will be reviewed up to 100 days after surgery or until hospital discharge. Researchers will collect information on respiratory status, recovery, intensive care, cardiac and neurological records, neurological tests, and mortality. The primary measure is the percentage of infants who experience cerebral desaturation within 24 hours around surgery. Secondary measures include EEG patterns and perioperative outcomes up to 100 days post-surgery.
CONDITIONS
Brief Title
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
Who Can Participate
Age: 0 - 60Weeks
All Genders
Eligibility Criteria
You may qualify if you...
- Infants 60 weeks post-menstrual age or younger on the day of surgery
- Undergoing neonatal surgery for congenital abdominal or gastrointestinal malformations such as diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, or necrotizing enterocolitis
- Undergoing surgery for congenital cystic adenomatoid or pulmonary airway malformations (CCAM/CPAM), esophageal or tracheoesophageal fistula, or spinal malformations like myelomeningocele or sacrococcygeal teratoma
- Same patient may be enrolled multiple times for repeat or different eligible procedures
- Parental or guardian permission obtained
You will not qualify if you...
- Patients with hydrocephalus limiting frontal-parietal brain volume
- Patients with interventricular hemorrhage grades 3 or 4
- Patients with malformation or cerebral infarction of the frontal-parietal brain
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Implementation
Duration - Approximately 1 to 2 days including surgery and postoperative monitoring
Participants have NIRS and EEG sensors placed about one hour before surgery. Monitoring continues during surgery and for up to 8 to 24 hours after surgery, with sensors removed at the end of recording. This monitoring does not require additional anesthesia or sedation and does not interfere with routine patient care.
1 surgical visit with continuous monitoring before, during, and after surgery
Long-term Monitoring
Duration - Up to 100 days post surgery
Participants' medical records are reviewed up to 100 days after surgery or until hospital discharge, whichever occurs sooner, to collect postoperative recovery information including respiratory, cardiac, neurologic status, and mortality status.
No additional in-person visits; medical record review only
Trial Site Locations
Total: 15 locations
1
Children's Hospital at Montefiore/Albert Einstein College of Medicine
New York, New York, United States, 10467
Not Yet Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Not Yet Recruiting
4
Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
5
Perth Children's Hospital
Nedlands, Australia
Actively Recruiting
6
Royal Children's Hospital
Parkville, Australia
Not Yet Recruiting
7
Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
São Paulo, Brazil
Actively Recruiting
8
Guangzhou women and children's medical center
Guangzhou, China
Not Yet Recruiting
9
Shanghai Children's Medical Center
Shanghai, China
Not Yet Recruiting
10
Shengjing Hospital of China Medical University
Shenyang, China
Not Yet Recruiting
11
West China Hospital and West China Second University Hospital
Sichuan, China
Not Yet Recruiting
12
Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants
Bordeaux, France
Not Yet Recruiting
13
Post Graduate Institute of Medical Education and Research
Chandigarh, India
Not Yet Recruiting
14
Christian Medical College Hospital
Vellore, India
Not Yet Recruiting
15
Great Ormond Street Hospital for Children
London, United Kingdom
Not Yet Recruiting
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Research Team
P
Paula Hu, RN, MSPH
E
Elizabeth Ramsay
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Early development of children with major birth defects requiring newborn surgery.
Sharon Laing, Karen Walker, Judy Ungerer...
https://pubmed.ncbi.nlm.nih.gov/21091587Neurodevelopmental Outcomes After Neonatal Surgery for Major Noncardiac Anomalies.
Lisanne J Stolwijk, Petra Ma Lemmers, Marissa Harmsen...
https://pubmed.ncbi.nlm.nih.gov/26759411Punctate White Matter Lesions Associated With Altered Brain Development And Adverse Motor Outcome In Preterm Infants.
Nora Tusor, Manon J Benders, Serena J Counsell...
https://pubmed.ncbi.nlm.nih.gov/29038505Neonatal Surgery for Noncardiac Congenital Anomalies: Neonates at Risk of Brain Injury.
Lisanne J Stolwijk, Kristin Keunen, Linda S de Vries...
https://pubmed.ncbi.nlm.nih.gov/28043688Predictive value of perioperative near-infrared spectroscopy for neurodevelopmental outcomes after cardiac surgery in infancy.
Erica D Sood, Julie S Benzaquen, Ryan R Davies...
https://pubmed.ncbi.nlm.nih.gov/23219333Perioperative cerebral oxygen saturation in neonates with hypoplastic left heart syndrome and childhood neurodevelopmental outcome.
George M Hoffman, Cheryl L Brosig, Kathleen A Mussatto...
https://pubmed.ncbi.nlm.nih.gov/23317941The Role of Regional Oxygen Saturation Using Near-Infrared Spectroscopy and Blood Lactate Levels as Early Predictors of Outcome After Pediatric Cardiac Surgery.
Vladimiro L Vida, Chiara Tessari, Alessia Cristante...
https://pubmed.ncbi.nlm.nih.gov/26868838Neurodevelopmental outcomes at 5years of age in congenital diaphragmatic hernia.
Enrico Danzer, Casey Hoffman, Jo Ann D'Agostino...
https://pubmed.ncbi.nlm.nih.gov/27622588Complications in neonatal surgery.
Mauricio A Escobar, Michael G Caty
https://pubmed.ncbi.nlm.nih.gov/27989360