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NCT05673499 Clinical Trial

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

Congenital Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05673499
Other study ID # 22-019679
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 12, 2022
Est. completion date December 2025

Study information
Verified date April 2024
Source Children's Hospital of Philadelphia
Contact Paula Hu, RN, MSPH
Phone 267-426-2961
Email hup@chop.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

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Study Design

Related Conditions & MeSH terms

Intervention

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.
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Sponsors (2)
Lead Sponsor Collaborator
Children's Hospital of Philadelphia Masimo Corporation

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  China,  France,  India,  United Kingdom, 

References & Publications (20)

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Outcome
Type Measure Description Time frame Safety issue
Primary 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 24 hours
Secondary Isoelectric EEG Determined by EEG amplitude = 10mV for = 2 secs up to 24 hours
Secondary Perioperative outcomes Medical record review up to 100 days
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