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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Oct 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a method called transcutaneous carbon dioxide monitoring (tcPCO2) in newborns who have a condition known as neonatal encephalopathy and are receiving a treatment called therapeutic hypothermia. Neonatal encephalopathy can occur when a baby's brain doesn't get enough oxygen at birth, and therapeutic hypothermia is a cooling treatment that helps protect the brain. The goal of the trial is to see if tcPCO2 can safely and accurately measure carbon dioxide levels in these babies without needing more invasive procedures.

If your baby is between 0 and 3 years old and has neonatal encephalopathy that requires therapeutic hypothermia, they may be eligible to participate in this study. To join, your baby should be at least 34 weeks old at birth and meet certain medical criteria, such as having a low Apgar score or showing signs of seizures. Participation in the trial will involve monitoring your baby closely during their treatment, and researchers will compare the tcPCO2 readings with other methods of measuring carbon dioxide. This study is a chance to help improve care for infants with this condition, and your baby's safety will always be the top priority.

Gender

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Eligibility 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