Neonatal Encephalopathy Clinical Trial
Official title:
Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 0 Days to 3 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Medtronic |
United States,
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Sorensen LC, Brage-Andersen L, Greisen G. Effects of the transcutaneous electrode temperature on the accuracy of transcutaneous carbon dioxide tension. Scand J Clin Lab Invest. 2011 Nov;71(7):548-52. doi: 10.3109/00365513.2011.590601. Epub 2011 Jul 6. — View Citation
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement between the tcPCO2 and PCO2 | We will obtain both the measurement of transcutaneous carbon dioxide (tcPCO2) and PCO2 in neonates receiving therapeutic hypothermia. The agreement between the PCO2 and tcPCO2 values will be analyzed using Bland-Altman Plot, where the mean and standard deviation of differences between two measurements will be calculated. | 3 years | |
Primary | Correlation between cerebral oxygen saturation and tcPCO2 | We will assess the correlation between cerebral oxygen saturation as a marker for cerebral perfusion and tcPCO2, as a marker of PCO2 in neonates receiving therapeutic hypothermia. | 3 years |
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