Neonatal Asphyxial Encephalopathy, Hypoxic Ischemic Encephalopathy
Conditions
Keywords
hypothermia treatment
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.
Interventions
OTHERhypothermia
Systemic hypothermia by Cincinnati Sub-Zero Blanketrol II®, servo-controlled to 33.0 degrees C rectal temperature, started within 6hours of hypoxic ischemic birth, and continued for 48hours
OTHERnormothermia
Rectal temperatures in neonates receiving normothermia were maintained at 37.0+or -0.5 degrees C, using overhead warmer or Cincinnati Sub-Zero Blanketrol II®, servo-controlled to rectal temperature of 37.0 degrees C.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Weeks to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death or severely abnormal Psychomotor Development Index scores on Bayley II | 12 months | Death or severe outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bradycardia | 0-96 hours | number of patients with heart rate \< 80 bpm |
Other
| Measure | Time frame | Description |
|---|---|---|
| coagulopathy | 1-4 days of life | Mean Prothrombin time |
| Death | by 12 months of age | numbers of patients who are withdrawn from support or die from multiorgan system failure |
Outcome results
None listed