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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00339001
Other study ID # SHEBA-06-4128-JK-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received June 19, 2006
Last updated June 19, 2006
Start date April 2006
Est. completion date December 2006

Study information

Verified date June 2006
Source Sheba Medical Center
Contact Jacob Kuint, MD
Phone 972-3-5303030
Email kuint-j@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal


Intervention

Drug:
erythropoietin and early iron supplements


Locations

Country Name City State
Israel Neonatal Department, Sheba Medical Center Ramat-Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

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