This trial is active, not recruiting.

Conditions hypoxic-ischemic encephalopathy, neonatal encephalopathy, birth asphyxia
Treatments erythropoietin, normal saline
Phase phase 1/phase 2
Sponsor University of California, San Francisco
Collaborator Thrasher Research Fund
Start date September 2013
End date January 2016
Trial size 50 participants
Trial identifier NCT01913340, P0055603-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
1000 U/kg/dose x 5 doses
erythropoietin Procrit
1000 U/kg/dose IV x 5 doses
(Placebo Comparator)
normal saline
placebo: NS IV x 5 doses

Primary Outcomes

Markers of organ function
time frame: Participants will be followed for the duration of hospital stay, an expected averaged of 2 weeks

Secondary Outcomes

Alberta Infant Motor Score (AIMS)
time frame: 12 months

Eligibility Criteria

Male or female participants up to 24 hours old.

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.

Additional Information

Official title Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes Study
Principal investigator Yvonne W Wu, MD, MPH
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.