NCT00945789

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
Last Updated

September 28, 2009

Status Verified

September 1, 2009

Enrollment Period

1.2 years

First QC Date

July 23, 2009

Last Update Submit

September 24, 2009

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Asphyxia neonatorumInfantsEEGBrain MRINitric oxide

Outcome Measures

Primary Outcomes (3)

  • Neurodevelopmental outcomes

    6 months

  • EEG changes

    2-3 weeks

  • MRI of the brain

    3 weeks

Secondary Outcomes (1)

  • Nitric oxide concentrations in the plasma

    2 weeks

Study Arms (3)

EPO HIE Group

EXPERIMENTAL

Infants with hypoxic ischemic encephalopathy receive human recombinant erythropoietin

Drug: Human recombinant erythropoietinProcedure: EEG and Brain MRIBiological: Nitric oxide measurement in the blood

Control HIE

NO INTERVENTION

Infants with hypoxic ischemic encephalopathy who do not receive treatment drug (EPO)

Procedure: EEG and Brain MRIBiological: Nitric oxide measurement in the blood

Healthy Controls

OTHER

Healthy newborn without hypoxic ischemic encephalopathy

Biological: Nitric oxide measurement in the blood

Interventions

Human recombinant erythropoietinDRUG

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

EPO HIE Group
EEG and Brain MRIPROCEDURE

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

Control HIEEPO HIE Group
Nitric oxide measurement in the bloodBIOLOGICAL

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

Control HIEEPO HIE GroupHealthy Controls

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Inborn infants at term gestation (38-42 weeks)
  • Apgar score ≤ 3 at 5 minutes and/or delayed first breath beyond five minutes after birth
  • Profound metabolic or mixed acidosis with serum bicarbonate \<12 mMol/L in initial arterial blood gas
  • Evidence of encephalopathy such as stupor, coma, seizures, or hypotonia in the immediate neonatal period

You may not qualify if:

  • Twin gestation
  • Maternal diabetes
  • Congenital malformations of the central nervous system
  • Chromosomal abnormalities
  • Chorioamnionitis and congenital infections
  • Intrauterine growth restriction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Faculty of Medicine

Tanta, Egypt

Location

Related Publications (1)

  • Elmahdy H, El-Mashad AR, El-Bahrawy H, El-Gohary T, El-Barbary A, Aly H. Human recombinant erythropoietin in asphyxia neonatorum: pilot trial. Pediatrics. 2010 May;125(5):e1135-42. doi: 10.1542/peds.2009-2268. Epub 2010 Apr 12.

    PMID: 20385632DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, BrainAsphyxia Neonatorum

Interventions

Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Vasodilator AgentsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

September 28, 2009

Record last verified: 2009-09

Locations

EG(1)