Neonatal Erythropoietin in Asphyxiated Term Newborns

Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00719407

Acronym

NEAT

Enrollment

Registered

2008-07-21

Start date

2010-01-31

Completion date

2012-11-30

Last updated

2012-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic-ischemic Encephalopathy

Keywords

birth asphyxia, neonatal encephalopathy, hypoxic-ischemic encephalopathy, neuroprotection, neonate

Brief summary

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.

Detailed 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.

Interventions

DRUGerythropoietin

250 U/kg/dose x 6 doses (n=3); 500 U/kg/dose x 6 doses (n=6); 1,000 U/kg/dose x 6 doses (n=7) 2,500 U/kg/dose x 6 doses (n=8)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 24 Hours

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

Design outcomes

Primary

Measure	Time frame
Serious adverse event	14 days of life

Secondary

Measure	Time frame
Pharmacokinetic parameters	1 to 11 days of life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026