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Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT00339001
Recruitment Status : Unknown
Verified June 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : June 20, 2006
Last Update Posted : June 20, 2006
Sponsor:
Information provided by:
Sheba Medical Center

Tracking Information
First Submitted Date June 19, 2006
First Posted Date June 20, 2006
Last Update Posted Date June 20, 2006
Study Start Date April 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity
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
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Retinopathy of Prematurity
Intervention Drug: erythropoietin and early iron supplements
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: June¬†19,¬†2006)
400
Original Enrollment Same as current
Study Completion Date December 2006
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages up to 3 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00339001
Other Study ID Numbers SHEBA-06-4128-JK-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Sheba Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Jacob Kuint, MD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date June 2006