NCT05673499 International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
| NCT ID | NCT05673499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Congenital Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2022-08-12 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2022-08-12 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Charles Dean Kurth, MD
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT05673499 clinical trial?
This trial is open to participants of all sexes, up to 60 Weeks, studying Congenital Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05673499 currently recruiting?
Yes, NCT05673499 is actively recruiting participants. Contact the research team at hup@chop.edu for enrollment information.
Where is the NCT05673499 trial being conducted?
This trial is being conducted at New York, United States, Philadelphia, United States, Dallas, United States, Houston, United States and 11 additional locations.
Who is sponsoring the NCT05673499 clinical trial?
NCT05673499 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Charles Dean Kurth, MD at Children's Hospital of Philadelphia. The trial plans to enroll 900 participants.