Neonatal Erythropoietin in Asphyxiated Term Newborns (NEAT)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 1

Conditions: Hypoxic-ischemic Encephalopathy

Treatments: Drug: erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT00719407

H9299-32566-01

Thrasher 02827-0

Details and patient eligibility

About

The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.

Full description

Newborn infants with birth asphyxia are at high risk of death or long-term neurologic disability; yet therapies for birth asphyxia are currently limited. Erythropoietin (Epo) is a FDA-approved drug that is an effective neuroprotective agent in animal models of birth asphyxia. This is a phase I dose finding multi-center trial that will test the safety and pharmacokinetics of Epo in human infants with birth asphyxia. The long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants who survive beyond the newborn period.

Enrollment: 24 patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 36 weeks gestational age
2. Perinatal depression (low Apgar score, need for resuscitation)
3. Moderate to severe encephalopathy

Exclusion criteria

1. Specific aEEG findings
2. Intrauterine growth restriction
3. Severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, TORCH infection
4. Microcephaly
5. Infant older than 23.5 hours of age at the time of consent
6. Infant judged by an attending physician to be likely to die due to the severity of illness
7. Polycythemia
8. Hypertension
9. No in-dwelling line

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

A

Experimental group

Description:

All enrolled patients will be in this single arm, who will receive experimental drug treatment.

Treatment:

Drug: erythropoietin