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Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00339001
First Posted: June 20, 2006
Last Update Posted: June 20, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  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:


Further study details as provided by Sheba Medical Center:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00339001     History of Changes
Other Study ID Numbers: SHEBA-06-4128-JK-CTIL
First Submitted: June 19, 2006
First Posted: June 20, 2006
Last Update Posted: June 20, 2006
Last Verified: June 2006

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

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Iron
Epoetin Alfa
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics