Actively Recruiting
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
281 weeks
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
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.
CONDITIONS
Official Title
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants 60 weeks post-menstrual age or younger on the day of surgery
- Neonatal surgery for congenital abdominal or gastrointestinal malformations such as diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, or necrotizing enterocolitis
- Neonatal surgery for congenital cystic adenomatoid or pulmonary airway malformation (CCAM/CPAM)
- Neonatal surgery for esophageal or tracheoesophageal fistula (EF/TEF)
- Neonatal surgery for spinal malformations including myelomeningocele or sacrococcygeal teratoma
- The same patient may be enrolled multiple times for repeat or different qualifying procedures
- Parental or guardian permission must be given
You will not qualify if you...
- Patients with hydrocephalus limiting frontal-parietal brain volume
- Patients with interventricular hemorrhage grade 3 or 4
- Patients with malformation or cerebral infarction of frontal-parietal brain
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
P
Paula Hu, RN, MSPH
CONTACT
E
Elizabeth Ramsay
CONTACT
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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