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ACTIVE NOT RECRUITING
NCT04603547

Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

Summary

The aim of our study is to evaluate the feasibility of applying transcutaneous CO2 monitoring (tcPCO2) in neonates receiving therapeutic hypothermia and to quantify the agreement between tcPCO2 and PCO2 in this population with or without respiratory support. Although, transcutaneous measurement of CO2 tension is the most commonly used non-invasive CO2 monitoring system in neonatal intensive care, to date tcPCO2 technique has not been evaluated systematically or used routinely in the intensive care of infants with neonatal encephalopathy receiving hypothermia treatment.

Key Details

Gender

All

Age Range

0 Days - 3 Days

Study Type

OBSERVATIONAL

Enrollment

53

Start Date

2019-09-28

Completion Date

2027-12-30

Last Updated

2026-02-25

Healthy Volunteers

Not specified

Interventions

DEVICE

Transcutaneous Carbon Dioxide Monitoring

Once an infant is identified as being eligible for TH treatment and hypothermia was initiated according to the department clinical practice guidelines, and written informed consent was obtained from one of the parents, tcPCO2 monitoring can be started. Transcutaneous CO2 will be measured by SenTec Digital Monitor (software version SW-V07.00; MPB SW-V05.00.12) with V-Sign™ Sensor (SenTec AG, Thervil, Switzerland). Also, we will use small blood samples (0.2 ml) from clinical blood draws up to 4 times following starting transcutaneous CO2 monitoring for measuring blood gas for research purposes.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States