Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Phase 2

Completed

• Conditions: Neonatal Asphyxial Encephalopathy; Hypoxic Ischemic Encephalopathy
• Interventions: Other: hypothermia; Other: normothermia

• Registration Number: NCT02826941
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 1999-06
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2016-05-23
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-05
• Last Update Submitted: 2016-07-05
• Study First Posted: 2016-07-11
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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Exclusion Criteria

• Maternal chorioamnionitis,
• sepsis at birth,
• birth weight or head circumference <10%,
• presumed chromosomal abnormality

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypothermia	hypothermia	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.
Normothermia	normothermia	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.

Primary Outcome Measures

Name	Time	Method
Death or severely abnormal Psychomotor Development Index scores on Bayley II	12 months	Death or severe outcomes

Secondary Outcome Measures

Name	Time	Method
bradycardia	0-96 hours	number of patients with heart rate \< 80 bpm