Retinopathy of PrematurityNCT00339001
Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity
An observational study of Retinopathy of Prematurity, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 2 weeks to 3 months
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- erythropoietin and early iron supplements
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2006to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all premature infants with birth weight of 1250 grams or less
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Irit Eisen, MD contact
Israel1 site, 1 recruiting
- Recruiting
Neonatal Department, Sheba Medical Center
Ramat Gan, 52621
Jacob Kuint, MD, 972-3-5303030 ext. 2227, kuint-j@sheba.health.gov.il
Irit Eisen, MD, 972-3-5303030 ext. 2227
About this study
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
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.
- Conditions
- Retinopathy of Prematurity
- Being tested
- erythropoietin and early iron supplements
- Keywords
- Erythropoietin, Iron, Retinopathy of prematurity
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietin and early iron supplementsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startApr 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Jacob Kuint, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339001
- Sponsor's protocol ID
- SHEBA-06-4128-JK-CTIL
- Status last verified
- Jun 2006
- First submitted
- 19 Jun 2006
- Last updated
- 20 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00339001
- Acronym / sponsor ID
- SHEBA-06-4128-JK-CTIL
- Conditions
- Retinopathy of Prematurity
- Keywords
- Erythropoietin, Iron, Retinopathy of prematurity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2006
- Study completion
- Dec 2006
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all premature infants with birth weight of 1250 grams or less
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erythropoietin and early iron supplements | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irit Eisen, MD contact
Jacob Kuint, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Kuint, MD (972-3-5303030 ext. 2227, kuint-j@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2006.