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

Drug Information available for: 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
Study 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 January 14, 2009