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

Conditions

• Cerebral Desaturation
• Congenital Disorders
• Neonatal Surgery

Eligibility Criteria

Sex

ALL

Age

N/A - 60 Weeks

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Aug 12, 2022

Status verified

Apr 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

900 participants (estimated)

Arms

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

Primary Outcome Measure

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

Central Contacts

• Paula Hu, RN, MSPH
  267-426-2961
  [email protected]
• Elizabeth Ramsay
  267-270-5087
  [email protected]

Locations (4)

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