An observational study in Congenital Disorders, Cerebral Desaturation and Neonatal Surgery, sponsored by Children's Hospital of Philadelphia. Recruiting at 15 sites in 7 countries. Open to participants aged Up to 60 Weeks. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Children's Hospital of Philadelphia · Observational
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:
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.
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:
22 studies on the registry are indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 14 are open to participants now.
Browse Congenital, Hereditary, and Neonatal Diseases and Abnormalities studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
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Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformat
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.
Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformations
Device: 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.
Percentage of participants with perioperative cerebral desaturation
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
Time frame: 24 hours
Isoelectric EEG
Determined by EEG amplitude ≤ 10mV for ≥ 2 secs
Time frame: up to 24 hours
Perioperative outcomes
Medical record review
Time frame: up to 100 days
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Congenital, Hereditary, and Neonatal Diseases and Abnormalities→
Children's Hospital of Philadelphia