Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Charite University, Berlin, Germany |
---|---|
Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00799721 |
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.
Condition |
---|
Infant, Very Low Birth Weight |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Urine samples that are centrifugated to get rid of any cells where stored at -80°C until ELISA is done.
Estimated Enrollment: | 160 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
---|
1
VLBW infants with erythropoietin therapy
|
2
VLBW infants without erythropoietin therapy.
|
Ages Eligible for Study: | up to 32 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Pretarem infants of less than 32 weeks of gestation or birth weight below 1500g.
Inclusion Criteria:
Exclusion Criteria:
Contact: Anke Reinhold, Doctor | +49/177/2950661 | anke.reinhold@charite.de |
Contact: Anja Pohl-Schickinger, Doctor | +49/30/450566122 | anja.pohl@charite.de |
Germany | |
Charité Virchow-Hospital | Recruiting |
Berlin, Germany, 13353 | |
Contact: Anke Reinhold, Doctor anke.reinhold@charite.de |
Responsible Party: | Charité University Berlin ( Dr. Anke Reinhold ) |
Study ID Numbers: | EA2/072/08-1 |
Study First Received: | November 28, 2008 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00799721 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
ROP VLBW Epo IUGR VEGF |
sFLT-1 very low birth weight infants retinopathy of prematurity erythropoietin therapy and risk of ROP |
Epoetin Alfa Body Weight Birth Weight Signs and Symptoms |
Retinopathy of prematurity Retinopathy of Prematurity Retinal Diseases |