Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

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.

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