Neonatal hypoxic-ischemic encephalopathy Neonatal Diseases Hypoxic ischaemic encephalopathy of newborn
Conditions
Interventions
A combination therapy with erythropoietin (300 mg/kg every other day for 2 weeks), magnesium sulfate (250 mg/kg for 3 days) and hypothermia was started within 6 hours of birth in neonates who met the
Sponsors
Osaka City General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Neonates admitted to the Osaka City General Hospital Neonatal Intensive Care Unit (NICU) and diagnosed with HIE, meeting institutional criteria for therapeutic hypothermia
Exclusion criteria
Exclusion criteria: 1. Infants older than 6 hours of birth at the time of initiation of hypothermia therapy 2. Infants with major congenital abnormalities 3. Infants with severe growth restriction with birth weight less than 1800 g 4. Infants who were considered critically ill and unlikely to bene?t from neonatal intensive care by the attending neonatologist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality and morbidity in neonatal period, measured by clinical records regarding in-hospital death, establishment of oral feeding, establishment of spontaneous respiration and brain MRI findings at 1 month of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Neurodevelopmental outcome measured using the Kyoto Scale of Psychological Development (KSPD) at 18 months of age | — |
Countries
Japan
Outcome results
None listed