Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy
Neonatal Asphyxial Encephalopathy, Hypoxic Ischemic Encephalopathy
About this trial
This is an interventional treatment trial for Neonatal Asphyxial Encephalopathy focused on measuring hypothermia treatment
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Hypothermia
Normothermia
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.
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.