Hypoxic Ischemic Encephalopathy
Conditions
Keywords
Hypoxic Ischemic Encephalopathy, Term neonate, Neuroprotection, erythropoietin
Brief summary
The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.
Detailed description
Hypoxic-ischemic encephalopathy remains the main cause of death or long term neurologic impairments in neonates. Yet, therapies for birth asphyxia are currently limited. Hypothermia when applied within 6 hours after birth demonstrate partial improvement in outcome of newborns specially those with moderate form. Erythropoietin and its receptors are upregulated after brain injury in ischemic conditions. Systemically administered erythropoietin is neuroprotective in animal models of birth asphyxia. To date, one study demonstrate improvement neurologic outcome in asphyxiated term newborn under erythropoietin treatment but no reports evaluating beneficial of erythropoietin associated with cooling. This is a large randomised controlled trial to evaluate the efficacy of high dose erythropoietin on outcome at two years of asphyxiated term newborns undergoing cooling.
Interventions
erythropoietin intravenous injection (5000 U/ 0.3 ml)1000 to 1500 U/kg/dose X 3 given every 24 hours with the first dose within 12 hours of delivery
DRUGPlacebo
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Hours
Healthy volunteers
No
Inclusion criteria
* Term or near-term newborn (\> = 36 weeks gestational age) * Moderate to severe encephalopathy * undergoing moderate controlled hypothermia started within 6 hours after delivery : rectal or esophageal temperature maintained at 33.5 ° C + / - 0.5 ° C before H6 * Beneficiary of social security plan * Informed consent parental authority
Exclusion criteria
* Impossibility of getting controlled hypothermia before H6 * Infant older than 12 hours of age * Chromosomal or significant congenital abnormality * Predictable surgery in the first 3 days of life * Uncontrolled collapse * Haemorrhagic syndrome unchecked * Head trauma with or without skull fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without neurologic sequelae | at 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rates | Within 24 months | number of dead patients |
| Rate of moderate and severe sequelae | at 24 months | Mental Developmental index (Brunet Lezine Test), motor, visual and hearing impairment |
| Aspect of brain lesions on MRI | at day 6 and day 12 after birth | Brain MRI performed between day 6 and day 12 after birth |
| Tolerance of treatment | at 24 months | — |
Countries
France
Outcome results
None listed