MedTrace Logo

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

NCT04603547 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2026-02-25

No results posted yet for this study

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.

Conditions

  • Neonatal Encephalopathy

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Mohamed El-Dib, MD · Brigham and Women's Hospital

Eligibility

Min Age
0 Days
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-28
Primary Completion
2024-10-30
Completion
2027-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04603547 on ClinicalTrials.gov