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

• Conditions: Infant, Very Low Birth Weight

• Registration Number: NCT00799721
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-08
• Study First Submitted: 2008-11-28
• Study First Submitted QC: 2008-11-28
• Last Update Submitted: 2008-11-28
• Study First Posted: 2008-12-01
• Last Update Posted: 2008-12-01
• Primary Completion: 2010-02
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• gestational age < 32 weeks
• birth weight <1500g

Exclusion Criteria

• absent written consent by parents
• connatal eye malformation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of ROP	4 months

Trial Locations

Locations (1)

Charité Virchow-Hospital; 🇩🇪 Berlin, Germany