Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Arkansas Children's Hospital Research Institute; Children's National Research Institute; Children's Research Institute; Kaiser Permanente; Seattle Children's Hospital; Stanford University; Thrasher Research Fund; Washington University School of Medicine
• Treatments: Epoetin Alfa

Criteria

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.