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Urine VEGF Levels in Very Low Birth Weight (VLBW) Infants

NCT ID: NCT00799721

Last Updated: 2008-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-12-31

Brief Summary

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VLBW infants are at risk of developing retinopathy of prematurity (ROP). In the first phase of ROP there is a down-regulation of retinal VEGF-expression because of postnatal relative hyperoxia, followed by an upregulation of VEGF mediated through retinal hypoxia, which leads to pathologic vessel formation. VEGF acts through binding to the specific receptor FLT-1, the soluble form sFLT-1 is a specific antagonist of VEGF action. Erythropoietin, given to VLBW infants to prevent anemia, may stimulate VEGF-production in neuronal cells. Currently, there are no data published about VEGF urine-levels in VLBW infants and it is not known, if urine VEGF-levels may serve as a non-invasive marker of ROP-risk. Further shall be investigated, if erythropoietin-therapy increases urine VEGF-levels and if there is a correlation with ROP-development.

Detailed Description

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Conditions

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Infant, Very Low Birth Weight

Keywords

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ROP VLBW Epo IUGR VEGF sFLT-1 very low birth weight infants retinopathy of prematurity erythropoietin therapy and risk of ROP

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

VLBW infants with erythropoietin therapy

No interventions assigned to this group

2

VLBW infants without erythropoietin therapy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* gestational age \< 32 weeks
* birth weight \<1500g

Exclusion Criteria

* absent written consent by parents
* connatal eye malformation
Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charité University Berlin

Locations

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Charité Virchow-Hospital

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Anke Reinhold, Doctor

Role: CONTACT

Phone: +49/177/2950661

Email: [email protected]

Anja Pohl-Schickinger, Doctor

Role: CONTACT

Phone: +49/30/450566122

Email: [email protected]

Facility Contacts

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Anke Reinhold, Doctor

Role: primary

Other Identifiers

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EA2/072/08-1

Identifier Type: -

Identifier Source: org_study_id