Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Medical University of South Carolina65 enrolled

Overview

This study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.

The trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers, and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by Bayley II or Vineland tests between normothermic and hypothermic groups. This trial identified potential safety outcomes, compared the adverse effects of hypothermia among hypoxic-ischemic encephalopathy (HIE) infants in the normothermic and hypothermic treatment groups, and obtained rates of adverse outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Neonatal Asphyxial Encephalopathy Hypoxic Ischemic Encephalopathy

Interventions

hypothermiaOTHER

Systemic hypothermia by Cincinnati Sub-Zero Blanketrol II®, servo-controlled to 33.0 degrees C rectal temperature, started within 6hours of hypoxic ischemic birth, and continued for 48hours

normothermiaOTHER

Rectal temperatures in neonates receiving normothermia were maintained at 37.0+or -0.5 degrees C, using overhead warmer or Cincinnati Sub-Zero Blanketrol II®, servo-controlled to rectal temperature of 37.0 degrees C.

Eligibility

Sex: ALLMin age: 35 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: One clinical indication of hypoxic-ischemic injury * cord gas pH ≤ 7.0 or base deficit ≥13, * initial infant gas pH \< 7.1, * Apgar score ≤5 at 10 minutes, * continued resuscitation after 5 min, * fetal bradycardia with heart rate \< 80 beats per minute lasting ≥15 min, * postnatal event O2 sat \<70% or arterial O2\<35 for 20 min with ischemia And two neurologic findings of neonatal encephalopathy, abnormalities of: * tone, * reflexes, * state of consciousness, * seizures, * posturing, * autonomic dysfunction Exclusion Criteria: * Maternal chorioamnionitis, * sepsis at birth, * birth weight or head circumference \<10%, * presumed chromosomal abnormality

Outcomes

Primary Outcomes

Death or severely abnormal Psychomotor Development Index scores on Bayley II

Death or severe outcomes

Time frame: 12 months

Secondary Outcomes

bradycardia

number of patients with heart rate \< 80 bpm

Time frame: 0-96 hours

Data from ClinicalTrials.gov

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