International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

Recruiting

• Conditions: Congenital Disorders; Cerebral Desaturation; Neonatal Surgery
• Interventions: Device: NIRS/EEG monitoring

• Registration Number: NCT05673499
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Detailed Description

The NIRS EEG sensors will be placed about an hour before surgery. The recording will start once sensors are placed, continue throughout the duration of surgery, and end 8-24 hours after end of surgery. Sensors will be removed at the end of recording. No additional anesthesia and/or sedation will be required for the preoperative and postoperative recordings. The EEG and NIRS monitors will be blinded to clinical staff. EEG and NIRS monitoring will not prolong anesthesia or the duration of the surgical repair, and should not interfere with routine patient care. NIRS and EEG data will be downloaded from the monitors at the end of recording for analysis.

Medical record review will be conducted at 100 days postop or hospital discharge (whichever is sooner). The information below will be extracted:

* Respiratory record

* Post-op recovery, ICU, and discharge records

* Cardiac and Neurologic records

* Neurologic test such as radiology and lab tests

* Mortality status

Study Timeline

• Study Start: 2022-08-12
• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants	NIRS/EEG monitoring	Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformations

Primary Outcome Measures

Name	Time	Method
Percentage of participants with perioperative cerebral desaturation	24 hours	The incidence of cerebral desaturation in participants will be assessed by the Near-infrared Spectroscopy (NIRS) data recording of \<70% and/or \>10% decrease from baseline for \> 3 minutes

Secondary Outcome Measures

Name	Time	Method
Perioperative outcomes	up to 100 days	Medical record review
Isoelectric EEG	up to 24 hours	Determined by EEG amplitude ≤ 10mV for ≥ 2 secs

Trial Locations

Locations (15)

Christian Medical College Hospital; 🇮🇳 Vellore, India

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India

Children's Hospital at Montefiore/Albert Einstein College of Medicine; 🇺🇸 New York, New York, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Medical Center Dallas; 🇺🇸 Dallas, Texas, United States

Children's Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States

Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo; 🇧🇷 São Paulo, Brazil

Perth Children's Hospital; 🇦🇺 Nedlands, Australia

Royal Children's Hospital; 🇦🇺 Parkville, Australia

Guangzhou women and children's medical center; 🇨🇳 Guangzhou, China

Shanghai Children's Medical Center; 🇨🇳 Shanghai, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, China

West China Hospital and West China Second University Hospital; 🇨🇳 Sichuan, China

Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants; 🇫🇷 Bordeaux, France

Great Ormond Street Hospital for Children; 🇬🇧 London, United Kingdom