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Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE)

NCT00945789 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2009-09-28

No results posted yet for this study

Summary

In this prospective trial the investigators plan to study the efficacy of erythropoietin as a therapeutic agent in neonates who suffer from brain injury following perinatal asphyxia.

Conditions

  • Hypoxic Ischemic Encephalopathy

Interventions

DRUG

Human recombinant erythropoietin

Epo dse is 2500 IU/kg subcutaneous daily for 5 days.

PROCEDURE

EEG and Brain MRI

EEG to be done twice in hte first 48 hours and at 2-3 weeks. MRI to be done at 3 weeks of age.

BIOLOGICAL

Nitric oxide measurement in the blood

Concentration of nitric oxide is measured in the blood at enrollment. For the 2 groups with asphyxia, measurement to be repeated in 2 weeks.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-12-31
Completion
2009-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00945789 on ClinicalTrials.gov