Erythropoietin and Early Iron Supplement and Retinopathy... | NCT00339001

Studies
Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity

NCT00339001

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jun 20, 2006Estimated

Enrollment

400

Phase

Not provided

Conditions

Retinopathy of Prematurity

Interventions

erythropoietin and early iron supplements

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Jun 19, 2006

First Submission Date that Met QC Criteria

Jun 19, 2006

First Posted Date

Jun 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2006

Last Update Posted Date

Jun 20, 2006Estimated

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400

Name	Type	Description	Arm Group Labels	Other Names
erythropoietin and early iron supplements	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all premature infants with birth weight of 1250 grams or less

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

3 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jacob Kuint, MD	Contact	972-3-5303030	2227	kuint-j@sheba.health.gov.il
Irit Eisen, MD	Contact	972-3-5303030	2227

Overall Officials

Name	Affiliation	Role
Jacob Kuint, MD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neonatal Department, Sheba Medical Center	Recruiting	Ramat Gan		52621	Israel

Condition Browse Module

MeSH Terms

ID	Term
D012178	Retinopathy of Prematurity

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004921	Erythropoietin

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided