NCT00491413

Brief Summary

Erythropoietin (Epo) is a hormone normally found in the body that may protect brain cells from damage due to lack of oxygen. This study will evaluate the safety of high-dose Epo in infants who did not get enough oxygen during birth.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
Last Updated

June 26, 2007

Status Verified

August 1, 2003

First QC Date

June 22, 2007

Last Update Submit

June 22, 2007

Conditions

Asphyxia

Keywords

neurodevelopmental outcomes

Interventions

epoetinDRUG

Eligibility Criteria

AgeUp to 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infant 6 hours of age or less
  • Apgar scores less than or equal to 3 at 1 and 5 minutes
  • Weight greater than 2500 grams (5.5 lbs)
  • Central venous line in place

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Asphyxia

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Robert D. Christensen, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

June 22, 2007

First Posted

June 26, 2007

Last Updated

June 26, 2007

Record last verified: 2003-08

Locations

US(1)