Monitoring brain oxygen and electrical activity in newborns during major surgery
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
Children's Hospital of Philadelphia · NCT05673499
This study looks at how brain oxygen levels and electrical activity change in newborns during major surgery to see if it affects their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | N/A to 60 Weeks |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia (other) |
| Locations | 15 sites (New York, New York and 14 other locations) |
| Trial ID | NCT05673499 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include infants up to 60 weeks post-menstrual age undergoing specific neonatal surgeries for congenital malformations.
Not a fit: Patients with severe brain conditions such as hydrocephalus or significant brain injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of cerebral desaturation in neonates, potentially leading to better monitoring and outcomes during major surgeries.
How similar studies have performed: Other studies have shown success in monitoring cerebral activity during surgeries, but this specific approach is novel in its focus on neonates.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York and 14 other locations
- Children's Hospital at Montefiore/Albert Einstein College of Medicine — New York, New York, United States (NOT_YET_RECRUITING)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (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)
- Perth Children's Hospital — Nedlands, Australia (RECRUITING)
- Royal Children's Hospital — Parkville, Australia (NOT_YET_RECRUITING)
- Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo — São Paulo, Brazil (RECRUITING)
- Guangzhou women and children's medical center — Guangzhou, China (NOT_YET_RECRUITING)
- Shanghai Children's Medical Center — Shanghai, China (NOT_YET_RECRUITING)
- Shengjing Hospital of China Medical University — Shenyang, China (NOT_YET_RECRUITING)
- West China Hospital and West China Second University Hospital — Sichuan, China (NOT_YET_RECRUITING)
- Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants — Bordeaux, France (NOT_YET_RECRUITING)
- Post Graduate Institute of Medical Education and Research — Chandigarh, India (NOT_YET_RECRUITING)
- Christian Medical College Hospital — Vellore, India (NOT_YET_RECRUITING)
- Great Ormond Street Hospital for Children — London, United Kingdom (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Disorders, Cerebral Desaturation, Neonatal Surgery, Electroencephalography, Near-infrared spectroscopy