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Neonatal Erythropoietin in Asphyxiated Term Newborns

NCT ID: NCT00719407

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Hypoxic-ischemic Encephalopathy

Keywords

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birth asphyxia neonatal encephalopathy hypoxic-ischemic encephalopathy neuroprotection neonate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type EXPERIMENTAL

erythropoietin

Intervention Type 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)

Interventions

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erythropoietin

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)

Intervention Type DRUG

Other Intervention Names

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Procrit

Eligibility Criteria

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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
Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thrasher Research Fund

OTHER

Sponsor Role collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Santa Clara Valley Health & Hospital System

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Yvonne Wu

Professor of Neurology and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yvonne W Wu, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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Rogers EE, Bonifacio SL, Glass HC, Juul SE, Chang T, Mayock DE, Durand DJ, Song D, Barkovich AJ, Ballard RA, Wu YW. Erythropoietin and hypothermia for hypoxic-ischemic encephalopathy. Pediatr Neurol. 2014 Nov;51(5):657-62. doi: 10.1016/j.pediatrneurol.2014.08.010. Epub 2014 Aug 27.

Reference Type DERIVED
PMID: 25439577 (View on PubMed)

Shankaran S. Outcomes of hypoxic-ischemic encephalopathy in neonates treated with hypothermia. Clin Perinatol. 2014 Mar;41(1):149-59. doi: 10.1016/j.clp.2013.10.008.

Reference Type DERIVED
PMID: 24524452 (View on PubMed)

Wu YW, Bauer LA, Ballard RA, Ferriero DM, Glidden DV, Mayock DE, Chang T, Durand DJ, Song D, Bonifacio SL, Gonzalez FF, Glass HC, Juul SE. Erythropoietin for neuroprotection in neonatal encephalopathy: safety and pharmacokinetics. Pediatrics. 2012 Oct;130(4):683-91. doi: 10.1542/peds.2012-0498. Epub 2012 Sep 24.

Reference Type DERIVED
PMID: 23008465 (View on PubMed)

Other Identifiers

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Thrasher 02827-0

Identifier Type: -

Identifier Source: secondary_id

H9299-32566-01

Identifier Type: -

Identifier Source: org_study_id