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Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Not Recruiting
Trial ID: NCT01913340
Purpose
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a
baby's brain near the time of birth, may cause death or neurologic disability. Cooling
therapy (hypothermia) provides some protection, but about half of affected infants still have
a poor outcome. This clinical trial will determine if the drug erythropoietin, given with
hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic
deficits after HIE.
Official Title
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study
Eligibility
Inclusion Criteria:
- Newborns ≥ 36 weeks gestation, < 23 hours of age at time of consent, must meet all 3
Inclusion Criteria to be eligible for the study:
1. Perinatal depression = at least one of the following: a) Apgar ≤5 at 10 min or b)
required resuscitation (endotracheal or mask ventilation, or chest compressions)
at 10 min or c) pH < 7.0 or base deficit ≥15 in cord, arterial, or venous blood
obtained at <60 min of age;
2. Moderate to severe encephalopathy = at least 3 of 6 modified Sarnat criteria
present between 1-6 h of birth: a) reduced level of consciousness; b) decreased
spontaneous activity; c) hypotonia; d) decreased suck; e) decreased Moro reflex;
or f) respiratory distress including periodic breathing or apnea; and
3. Hypothermia = passive or active cooling begun by 6 hours of age.
Exclusion Criteria:
- Intrauterine growth restriction (BW <1800 g);
- Major congenital malformation; suspected genetic syndrome, metabolic disorder or TORCH
infection;
- Head circumference < 2 SD for gestation;
- Infant for whom withdrawal of supportive care is being considered; or
- Anticipated inability to collect primary endpoint at 12 months of age.
Intervention(s):
drug: Erythropoietin
drug: Normal saline
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Krisa Van Meurs, MD
6507235711