Ensayos clínicos
Search for actively enrolling clinical trials
COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants with Mild Encephalopathy
Study ID: STU-2022-0714
Summary
This study leverages practice variation within and across 15 participating sites to compare the effectiveness of TH versus normothermia for mild Hie on neurodevelopmental outcomes at 2 years of age. after standardizing all aspects of clinical care for mild Hie (except for TH vs. normothermia) we will enroll 460 infants with mild Hie into the longitudinal, observational comparative effectiveness study. The central aim of the comparative longitudinal cohort of mild Hie is (1) to compare the effectiveness of hypothermia to normothermia on neurodevelopmental outcomes at 2 years, (2) to determine the adverse effects of TH on the infant and his/her family (3) determine the heterogeneity of treatment effects (moderating effect) across mild Hie subgroups as determined by physiological biomarkers obtained during the 6 hours window to initiate hypothermia. The decision to apply TH or normothermia will be entirely determined by practice parameters at each site.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- LINA FAHD CHALAK
PATIENT-CENTERED OUTCOMES RESEARCH INST
Brain and Nervous System
To Determine the effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild Hie. To determine the adverse effects of TH in mild Hie on the neonate and his/her family. adverse neonatal effects include prolonged length of hospital stay, bleeding, or coagulopathy during hospitalization. adverse effects on the family include parental stress, impaired parent-infant bonding, and reduced breastfeeding using validated surveys assessed at 4 months of age. Determine heterogeneity of the treatment effect across key subgroups. We will assess the treatment effect as a function of the total Sarnat Score, and aeeG/eeG abnormalities (background and sleep-wake cycling) obtained in the first 6 hours after birth prior to the decision to initiate therapy.
