At a glance
ClinicalIndex Comparison Record- ✓Gestational age ≥36 completed weeks
- ✓At least one sign of perinatal distress: Apgar ≤5 at 10 min, continued resuscitation at 10 min, umbilical/arterial/capillary pH <7.00 within 60 min, or base deficit ≥16 mmol/L within 60 min
- ✓Moderate to severe encephalopathy: altered consciousness (lethargy, stupor, or coma) AND at least one neurological sign (hypotonia, abnormal reflexes/oculomotor or pupillary abnormalities, absent/weak suck, or clinical seizures)
- ✓Abnormal aEEG within 30+ minutes of recording showing normal background with seizure activity, moderately abnormal activity, suppressed activity, or continuous seizure activity
- ✕Expected age >6 hours at time of randomization
- ✕Major congenital abnormalities such as diaphragmatic hernia requiring ventilation or chromosomal/syndromic abnormalities with brain dysgenesis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy
In Brief
A clinical study evaluating Whole body mild induced hypothermia for Asphyxia Neonatorum and 3 related conditions. Completed, enrolled 325 participants across 1 site.
Detailed Summary
Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability. This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.
Study Details
Timeline
Interventions
Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia