Neonatal Erythropoietin in Asphyxiated Term Newborns (NEAT)

November 7, 2012 updated by: Yvonne Wu, University of California, San Francisco

Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
All enrolled patients will be in this single arm, who will receive experimental drug treatment.
Drug: 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)
Other Names:
  • Procrit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serious adverse event
Time Frame: 14 days of life
14 days of life

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters
Time Frame: 1 to 11 days of life
1 to 11 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 17, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 7, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H9299-32566-01
  • Thrasher 02827-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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