Monitoring carbon dioxide levels in newborns with brain injury receiving cooling treatment
Official title: Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
Run by Brigham and Women's Hospital · NCT04603547 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new way to monitor carbon dioxide levels in newborns with brain injury who are receiving cooling treatment to see if it works as well as the usual methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 3 Days |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04603547 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are neonates with neonatal encephalopathy who are admitted for therapeutic hypothermia.
✕Probably not a fit
Patients with major birth defects or those in extremis with a focus on palliative care may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the feasibility of using transcutaneous carbon dioxide monitoring (tcPCO2) in neonates undergoing therapeutic hypothermia for neonatal encephalopathy. It aims to quantify the agreement between tcPCO2 and traditional PCO2 measurements in this vulnerable population, which may include infants with or without respiratory support. Given the high incidence of hypocarbia in these patients, the study seeks to optimize their intensive care and potentially improve neurodevelopmental outcomes. The research is particularly significant as tcPCO2 has not been systematically evaluated in this context before.
Why it matters
Potential benefit: If successful, this study could enhance monitoring techniques and improve outcomes for infants with neonatal encephalopathy receiving therapeutic hypothermia.
How similar studies have gone: While the use of tcPCO2 monitoring is common, this specific application in neonates with encephalopathy undergoing hypothermia has not been previously tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria Any neonates with neonatal encephalopathy admitted to receive therapeutic hypothermia will be a candidate for this study. Current criteria for therapeutic hypothermia at BWH include the following: 1. ≥34 weeks' gestation + 2. Any one of the followings 1. Sentinel event prior to delivery 2. Apgar score ≤ 5 at 10 min 3. Requires PPV, Intubation or CPR at 10 min 4. 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) + 3. Any one of the followings: 1. Neonatal Encephalopathy Scale Exam Score ≥4 2. Seizure or clinical concern for seizure Exclusion criteria 1. Infants with major birth defect, genetic or metabolic syndrome 2. Neonates in extremis with possibility of redirection to palliative care
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Mohamed El-Dib, MD — Brigham and Women's Hospital
- Study coordinator: Mohamed El-Dib, MD
- Email: mel-dib@bwh.harvard.edu
- Phone: 6177326902
Similar studies
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Using breast milk to treat brain injury in newborns
This study is testing if giving breast milk through the nose can help newborns with brain injuries feel better and develop normally while they are being treated with cooling therapy.
-
Using intranasal breast milk to improve outcomes in newborns with brain injury
This study is testing if giving fresh breast milk through the nose can help newborns with brain injury do better in the long run compared to standard care.
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This study is testing if sildenafil can help newborns with brain injuries from lack of oxygen at birth recover better after treatment with cooling therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.