Neonatal Erythropoietin in Asphyxiated Term Newborns - Full Text View

Neonatal Erythropoietin in Asphyxiated Term Newborns (NEAT)

This study is not yet open for participant recruitment.

Verified by University of California, San Francisco, July 2008

Sponsors and Collaborators:	University of California, San Francisco Thrasher Research Fund Children's Hospital & Research Center Oakland University of Washington Santa Clara Valley Health & Hospital System
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00719407

Purpose

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

Condition	Intervention	Phase
Hypoxic-Ischemic Encephalopathy	Drug: erythropoietin	Phase I

Drug Information available for: Epoetin alfa Erythropoietin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Serious adverse event [ Time Frame: 14 days of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic parameters [ Time Frame: 1 to 4 days of life ] [ Designated as safety issue: No ]

Estimated Enrollment:	26
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental All enrolled patients will be in this single arm, who will receive experimental drug treatment.	Drug: erythropoietin 1,000 U/kg/dose x 3 daily doses (n=3); 2,500 U/kg/dose x 3 daily doses (n=3); 5,000 U/kg/dose x 3 daily doses (n=20)

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 phase I multi-center trial will test the safety and pharmacokinetics of acute high-dose Epo as a neuroprotective agent 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.

Eligibility

Ages Eligible for Study:	up to 24 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719407

Contacts

Contact: Yvonne W Wu, MD, MPH	415-353-3678	wuy@neuropeds.ucsf.edu
Contact: Jeanette Asselin, RT	(510) 528-3763	JAsselin@mail.cho.org

Sponsors and Collaborators

University of California, San Francisco

Thrasher Research Fund

Children's Hospital & Research Center Oakland

University of Washington

Santa Clara Valley Health & Hospital System

Investigators

Principal Investigator:

Yvonne W Wu, MD, MPH

University of California, San Francisco

More Information

Responsible Party:	University of California, San Francisco ( Yvonne Wu, MD, MPH )
Study ID Numbers:	H9299-32566-01, Thrasher 02827-0
Study First Received:	July 17, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00719407
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:

birth asphyxia
neonatal encephalopathy
hypoxic-ischemic encephalopathy
neuroprotection
neonate

Study placed in the following topic categories:

Epoetin Alfa
Asphyxia Neonatorum
Hypoxia-Ischemia, Brain
Hypoxia, Brain
Vascular Diseases
Central Nervous System Diseases

Brain Ischemia
Asphyxia neonatorum
Ischemia
Brain Diseases
Cerebrovascular Disorders
Asphyxia

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents

Nervous System Diseases
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 10, 2009