Recruiting

Observational Study

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05673499

Conditions

Congenital Disorders

Cerebral Desaturation

Neonatal Surgery

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

NIRS/EEG monitoring

Study Details

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.

Conditions

Congenital Disorders

Cerebral Desaturation

Neonatal Surgery

Study ID

NCT05673499

Start date

Aug 12, 2022

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

Infants

Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformations

Interventions

NIRS/EEG monitoring

The study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.

Primary outcome measure

  • Percentage of participants with perioperative cerebral desaturation [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Paula Hu, RN, MSPH

267-426-2961hup@chop.edu

Elizabeth Ramsay

267-270-5087ramsaye2@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Charles Dean Kurth, MD

215-590-1866KURTHCD@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Electroencephalography
  • Near-infrared spectroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-04-23.