Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Conditions
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Neonatal Asphyxial Encephalopathy, Hypoxic Ischemic Encephalopathy

Intervention / Treatment
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* Other: hypothermia
* Other: normothermia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypothermia<br>If randomized to hypothermia, plastic bags filled with ice wrapped in a washcloth were applied to the head and body for approximately 2 hours, then the infant was placed on an adult-size, water-circulating, cooling blanket (Cincinnati Sub-Zero Blanketrol II®, Cincinnati, OH), servo-controlled to rectal temperature to 33 ± 0.5 °C for 48 hours at the participating tertiary care center. Rewarming by 0.5°C per hour was begun after 48 hours of hypothermia. | Other: hypothermia<br>* 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<br>* Other names: whole body cooling;|
| Placebo Comparator: Normothermia<br>If randomized to normothermia, rectal temperatures were maintained at 37 ± 0.5 °C per standard neonatal intensive care unit practice, using adult-size, water-circulating, cooling blanket (Cincinnati Sub-Zero Blanketrol II®, Cincinnati, OH), servo-controlled to rectal temperature of 37 ± 0.5 if baby was febrile. | Other: normothermia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or severely abnormal Psychomotor Development Index scores on Bayley II | Death or severe outcomes | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bradycardia | number of patients with heart rate < 80 bpm | 0-96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothermia treatment