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Completed

NCT Number: NCT00719407

Neonatal Erythropoietin in Asphyxiated Term Newborns

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.

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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Asphyxia Neonatorum Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Infant, Newborn, Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Erythropoietin

Drug

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)

Other names: Procrit

Primary outcomes

  1. Serious adverse event

    Time frame: 14 days of life

Secondary outcomes

  1. Pharmacokinetic parameters

    Time frame: 1 to 11 days of life

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Santa Clara Valley Health & Hospital System
  • Thrasher Research Fund
  • UCSF Benioff Children's Hospital Oakland
  • University of Washington

Registry information

Official study title

Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial

Acronym: NEAT

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 21, 2008
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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