NCT00339001

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 20, 2006

Status Verified

June 1, 2006

First QC Date

June 19, 2006

Last Update Submit

June 19, 2006

Conditions

Retinopathy of Prematurity

Keywords

ErythropoietinIronRetinopathy of prematurity

Interventions

erythropoietin and early iron supplementsDRUG

Eligibility Criteria

Age2 Weeks - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Department, Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Jacob Kuint, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Kuint, MD

CONTACT

972-3-5303030kuint-j@sheba.health.gov.il

Irit Eisen, MD

CONTACT

972-3-5303030

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 20, 2006

Study Start

April 1, 2006

Study Completion

December 1, 2006

Last Updated

June 20, 2006

Record last verified: 2006-06

Locations

IL(1)