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Cool Prime Comparative Effectiveness Study for Mild HIE | Clinical Trials | Clareo Health

RECRUITING

Cool Prime Comparative Effectiveness Study for Mild HIE

COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy

NCT04621279•University of Texas Southwestern Medical Center

Summary

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.

Detailed Description

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) determine the adverse effects of TH on the infant and his/her family; and (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.

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Neonates born at ≥ 36 0/7 weeks
•2. Mild Encephalopathy on neonatal neurologic exam within 6 hours after birth: defined as presence of at least 2 signs of mild, moderate, or severe encephalopathy with no more than 2 signs in the moderate or severe category.
•3. Perinatal Acidosis based on at least one of the following (A or B):
•1. pH ≤ 7.00 in any cord or first infant gas (arterial, venous, or capillary) within ≤ 60 min OR base deficit ≥ 16 in any cord or first infant gas (arterial, venous or capillary) within ≤ 60 min
•2. If pH is between 7.01 and 7.15, OR base deficit is between 10 and 15.9 mmol/liter, OR blood gas is not available, an acute perinatal event is an additional criteria required (see below definition)
•An acute perinatal event is defined by at least one of the following:
•1. Apgar score at 10 min ≤ 5
•2. Continued need for resuscitation at 10 min (chest compressions, bag mask ventilation, or positive pressure ventilation)
•3. Uterine rupture, placental abruption, cord accident (prolapse, rupture, knot or tight nuchal cord)
•4. maternal trauma, maternal hemorrhage, or cardiorespiratory arrest
+3 more criteria

Exclusion Criteria

•1. Gestational age at birth \< 36 0/7 weeks
•2. Birth weight \< 1800gm
•3. Head circumference \<30cm
•4. Congenital or chromosomal anomaly associated with abnormal neurodevelopment or death
•5. Moderate or Severe HIE of 3 or more moderate or severe abnormalities on COOLPRIME Sarnat exam within 6 hours of life
•6. Any seizures within first six hours of life
•7. Redirection of care is being considered

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Start Date

July 19, 2023

Primary Completion Date

October 31, 2026

Completion Date

January 1, 2029

Last Updated

December 8, 2025

Enrollment

460

ESTIMATED participants

Conditions

Mild Hypoxic Ischemic Encephalopathy of Newborn

Interventions

Normothermia

PROCEDURE

Whole body therapeutic hypothermia

PROCEDURE

Contacts

Lina Chalak, MD

CONTACT

214-648-3903 lina.chalak@utsouthwestern.edu

Pollieanna Sepulveda, MSN, RN

CONTACT

214-648-3698 pollieanna.sepulveda@utsouthwestern.edu