Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonat… (NCT04603547) | Clinical Trial Compass
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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 range
0 Days – 3 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement between the tcPCO2 and PCO2
Timeframe: 3 years
2
Correlation between cerebral oxygen saturation and tcPCO2