Education and Training

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

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.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: Erythropoietin
  • drug: Normal saline

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.

Ages Eligible for Study

30 Minutes - 24 Hours

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Krisa Van Meurs, MD
6507235711
Not Recruiting