| Registry | NCT02826941 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 65 (Actual) |
| Sponsor | Medical University of South Carolina (Other); collaborators: National Institute of Neurological Disorders and Stroke (NINDS) |
| Conditions | Neonatal Asphyxial Encephalopathy, Hypoxic Ischemic Encephalopathy |
| Interventions | hypothermia, normothermia (Other) |
| Dates | start 1999-06-01, primary completion 2004-06-01, completion 2004-06-01, first posted 2016-07-11, last updated 2016-07-11 |
Related Papers Related Patents Related Grants Related Experts
All trials for Neonatal Asphyxial Encephalopathy All trials for Hypoxic Ischemic Encephalopathy All trials of hypothermia All trials of normothermia
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Hypothermia | Experimental | Other: 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 | Placebo comparator | Other: 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. |
Sex: All, ages: 35 Weeks to any
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
NIH grants: R01NS038062