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Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study

Details

This phase I/II clinical trial is designed to demonstrate:

  1. The feasibility of recruiting, enrolling and following 50 patients with moderate to severe HIE at 5 sites, while meeting specified recruitment and follow-up target goals.
  2. The safety of high-dose Epo therapy in neonates with HIE with respect to systemic organ function and general growth parameters.
  3. The value of brain MRI/MRS performed at 4-7 days of age as a biomarker of motor function at 12 months of age.

Keywords

Hypoxic-ischemic Encephalopathy Neonatal Encephalopathy Birth Asphyxia erythropoietin therapeutic hypothermia Hypothermia Brain Diseases Brain Ischemia Hypoxia-Ischemia, Brain Asphyxia Asphyxia Neonatorum Epoetin Alfa

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSF
    San Francisco, California, 94143, United States
  • Stanford University
    Palo Alto, California, United States
  • Kaiser Permanente, Santa Clara
    Santa Clara, California, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT01913340
Phase
Phase 1/2
Lead Scientist
Yvonne Wu
Study Type
Interventional
Last Updated
March 2016