Monitoring carbon dioxide levels in newborns with brain injury receiving cooling treatment
Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 0 Days to 3 Days |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04603547 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates with neonatal encephalopathy who are admitted for therapeutic hypothermia.
Not a fit: Patients with major birth defects or those in extremis with a focus on palliative care may not benefit from this study.
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 performed: While the use of tcPCO2 monitoring is common, this specific application in neonates with encephalopathy undergoing hypothermia has not been previously tested.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.