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Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity

This study is currently recruiting participants.
Verified by Sheba Medical Center, June 2006

Sponsored by: Sheba Medical Center
Information provided by: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00339001
  Purpose

To evaluate the possibility that erythropoietin with early iron supplementation may induce retinopathy of prematurity or worsen this disease. In addition risk factors for the development of ROP will be checked.


Condition Intervention
Retinopathy of Prematurity
Drug: erythropoietin and early iron supplements

MedlinePlus related topics:   Dietary Supplements    Retinal Disorders   

ChemIDplus related topics:   Epoetin alfa    Erythropoietin    Ferrous sulfate   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Longitudinal, Defined Population, Retrospective Study
Official Title:   The Possible Influence of Erythropoietin and Early Iron Supplements on the Prevalence and Severity of Retinopathy of Prematurity and Other Short Term Outcome of Prematurity

Further study details as provided by Sheba Medical Center:

Estimated Enrollment:   400
Study Start Date:   April 2006
Estimated Study Completion Date:   December 2006

  Eligibility
Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • all premature infants with birth weight of 1250 grams or less

Exclusion Criteria:

  • none
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339001

Contacts
Contact: Jacob Kuint, MD     972-3-5303030 ext 2227     kuint-j@sheba.health.gov.il    
Contact: Irit Eisen, MD     972-3-5303030 ext 2227    

Locations
Israel
Neonatal Department, Sheba Medical Center     Recruiting
      Ramat-Gan, Israel, 52621
      Contact: Jacob Kuint, MD     972-3-5303030 ext 2227     kuint-j@sheba.health.gov.il    
      Contact: Irit Eisen, MD     972-3-5303030 ext 2227        
      Principal Investigator: Irit Eisen, MD            
      Sub-Investigator: Robi Chaviv, med. student            

Sponsors and Collaborators
Sheba Medical Center

Investigators
Principal Investigator:     Jacob Kuint, MD     Sheba Medical Center    
  More Information


Study ID Numbers:   SHEBA-06-4128-JK-CTIL
First Received:   June 19, 2006
Last Updated:   June 19, 2006
ClinicalTrials.gov Identifier:   NCT00339001
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Erythropoietin  
Iron  
Retinopathy of prematurity  

Study placed in the following topic categories:
Epoetin Alfa
Eye Diseases
Retinopathy of prematurity
Infant, Newborn, Diseases
Infant, Premature, Diseases
Retinopathy of Prematurity
Iron
Retinal Diseases

Additional relevant MeSH terms:
Hematinics
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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