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NCT00799721 Clinical Trial

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

Infant, Very Low Birth Weight Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00799721
Other study ID # EA2/072/08-1
Secondary ID
Status Recruiting
Phase N/A
First received November 28, 2008
Last updated November 28, 2008
Start date August 2008
Est. completion date December 2010

Study information
Verified date August 2008
Source Charite University, Berlin, Germany
Contact Anke Reinhold, Doctor
Phone +49/177/2950661
Email anke.reinhold@charite.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date December 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 32 Weeks
Eligibility Inclusion Criteria:

- gestational age < 32 weeks

- birth weight <1500g

Exclusion Criteria:

- absent written consent by parents

- connatal eye malformation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Charité Virchow-Hospital Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development of ROP 4 months No
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