Urine VEGF Levels in Very Low Birth Weight (VLBW) Infants
1 other identifier
observational
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 28, 2008
CompletedFirst Posted
Study publicly available on registry
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 1, 2008
August 1, 2008
1.5 years
November 28, 2008
November 28, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of ROP
4 months
Study Arms (2)
1
VLBW infants with erythropoietin therapy
2
VLBW infants without erythropoietin therapy.
Eligibility Criteria
Pretarem infants of less than 32 weeks of gestation or birth weight below 1500g.
You may qualify if:
- gestational age \< 32 weeks
- birth weight \<1500g
You may not qualify if:
- absent written consent by parents
- connatal eye malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité Virchow-Hospital
Berlin, State of Berlin, 13353, Germany
Biospecimen
Urine samples that are centrifugated to get rid of any cells where stored at -80°C until ELISA is done.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 28, 2008
First Posted
December 1, 2008
Study Start
August 1, 2008
Primary Completion
February 1, 2010
Study Completion
December 1, 2010
Last Updated
December 1, 2008
Record last verified: 2008-08