Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Neonatal Asphyxial Encephalopathy; Hypoxic Ischemic Encephalopathy

Treatments: Other: normothermia; Other: hypothermia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02826941

R01NS038062 (U.S. NIH Grant/Contract)

NS38062

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 35+ weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups, including a placebo group

Hypothermia

Experimental group

Description:

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.

Treatment:

Other: hypothermia

Normothermia

Placebo Comparator group

Description:

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.

Treatment:

Other: normothermia