Summary

Dates
study started
estimated completion

Description

Summary

To determine 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. Determine heterogeneity of the treatment effect across key subgroups obtained in the first 6 hours after birth prior to the decision to initiate therapy.

Official Title

COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy

Details

This study leverages practice variation within and across 12 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.

Keywords

Mild Hypoxic Ischaemic Encephalopathy of Newborn mild HIE neonatal encephalopathy brain ischemia brain hypoxia Brain Diseases Hypoxia-Ischemia, Brain Normothermia Whole body therapeutic hypothermia Mild Hypoxic Ischemic Encephaolpathy

Eligibility

You can join if…

  • Infant ≥ 36 0/7 weeks with evidence of BOTH
  • Perinatal depression as defined by NICHD based on at least one of the following; pH <7.00 in a cord gas or Base deficit ≥15 mmol/L in a gas (arterial or venous) obtained at <60 min of age, Apgar score <5 at 10 minutes, or Need for resuscitation at 10 minutes (i.e., chest compressions, or positive pressure respiratory support including endotracheal, mask ventilation, or CPAP).
  • Mild encephalopathy, as defined by PRIME-study 1-6 hours after birth:

At least 1 of 6 Sarnat criteria is scored as a mild, moderate, or severe abnormality, and Fewer than 3 of 6 Sarnat criteria are scored as a moderate or severe abnormality

You CAN'T join if...

  1. Birthweight <1800g (i.e., intrauterine growth restriction)
  2. Head circumference <30cm
  3. Confirmed clinical or EEG seizures in the first 6 hours of life
  4. Congenital malformation or genetic syndrome

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Texas Southwestern Medical Center
ID
NCT04621279
Study Type
Observational
Last Updated