Active — Not RecruitingNot Applicable

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

United States53 participantsStarted 2019-09-28

Plain-language 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.

Who can participate

Age range0 Days – 3 Days

SexALL

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Inclusion criteria

✓. ≥34 weeks' gestation
✓. Any one of the followings
✓. Sentinel event prior to delivery
✓. Apgar score ≤ 5 at 10 min
✓. Requires PPV, Intubation or CPR at 10 min
✓. pH ≤ 7.1 (from cord or blood gas within 60 min of birth) e. Abnormal Base Excess ≤ - 10 mEq/L (from cord or blood gas within 60 min of birth) +
✓. Any one of the followings:
✓. Neonatal Encephalopathy Scale Exam Score ≥4

Exclusion criteria

✕. Infants with major birth defect, genetic or metabolic syndrome
✕. Neonates in extremis with possibility of redirection to palliative care

What they're measuring

Agreement between the tcPCO2 and PCO2

Timeframe: 3 years

Correlation between cerebral oxygen saturation and tcPCO2

Timeframe: 3 years

Trial details

NCT IDNCT04603547

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-30

View on ClinicalTrials.gov More Neonatal Encephalopathy trials