Actively Recruiting
Cool Prime Comparative Effectiveness Study for Mild HIE
Led by University of Texas Southwestern Medical Center · Updated on 2026-05-05
460
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
U
University of California, San Francisco
Collaborating Sponsor
AI-Summary
What this Trial Is About
To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family. Determine heterogeneity of the treatment effect across key subgroups obtained in the first 6 hours after birth prior to the decision to initiate therapy.
CONDITIONS
Official Title
Cool Prime Comparative Effectiveness Study for Mild HIE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates born at 36 0/7 weeks gestation or later
- Mild encephalopathy on neonatal neurologic exam within 6 hours after birth, defined as at least 2 signs of mild, moderate, or severe encephalopathy with no more than 2 signs in moderate or severe category
- Perinatal acidosis based on at least one of the following: pH 64 7.00 in any cord or first infant blood gas within 60 minutes; or base deficit 65 16 in any cord or first infant blood gas within 60 minutes
- If pH is between 7.01 and 7.15, or base deficit between 10 and 15.9, or blood gas unavailable, an acute perinatal event must be present such as Apgar score at 10 min 64 5, continued resuscitation at 10 min, uterine rupture, placental abruption, cord accident, maternal trauma, hemorrhage or arrest, fetal exsanguination, shoulder dystocia, or other evidence of acute perinatal event
- Infants remain eligible if cord or first blood gas is obtained more than 60 minutes after birth
You will not qualify if you...
- Gestational age at birth less than 36 0/7 weeks
- Birth weight less than 1800 grams
- Head circumference less than 30 cm
- Congenital or chromosomal anomalies associated with abnormal neurodevelopment or death
- Moderate or severe HIE defined by 3 or more moderate or severe abnormalities on Sarnat exam within 6 hours of life
- Any seizures within first six hours of life
- Consideration of redirection of care
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75208
Actively Recruiting
Research Team
L
Lina Chalak, MD
CONTACT
P
Pollieanna Sepulveda, MSN, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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