Monitoring brain oxygen and electrical activity in newborns during major surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the incidence of cerebral desaturation in neonates undergoing surgery for congenital disorders. Participants will have Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring initiated one hour before surgery, continuing through the procedure and up to 24 hours post-surgery. The study will analyze perioperative factors associated with cerebral desaturation and its impact on hospital outcomes. Data will be collected from medical records at 100 days post-operation or upon hospital discharge.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Perth Children's Hospital
  Nedlands, Australia Recruiting
• Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
  São Paulo, Brazil Recruiting
• Children's Hospital at Montefiore/Albert Einstein College of Medicine
  New York, New York, United States Not yet recruiting
• Children's Medical Center Dallas
  Dallas, Texas, United States Not yet recruiting
• Children's Memorial Hermann Hospital
  Houston, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Charles Dean Kurth, MD — Children's Hospital of Philadelphia
• Study coordinator: Paula Hu, RN, MSPH
• Email: hup@chop.edu
• Phone: 267-426-2961

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.