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Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00339001
First received: June 19, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Retrospective
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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

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

Additional relevant MeSH terms:
Infant, Newborn, Diseases
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Epoetin Alfa
Iron
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013