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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00799721
Recruitment Status : Unknown
Verified August 2008 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : December 1, 2008
Last Update Posted : December 1, 2008
Information provided by:
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.

Condition or disease
Infant, Very Low Birth Weight

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2008
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : December 2010

VLBW infants with erythropoietin therapy
VLBW infants without erythropoietin therapy.

Primary Outcome Measures :
  1. Development of ROP [ Time Frame: 4 months ]

Biospecimen Retention:   Samples Without DNA
Urine samples that are centrifugated to get rid of any cells where stored at -80°C until ELISA is done.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pretarem infants of less than 32 weeks of gestation or birth weight below 1500g.

Inclusion Criteria:

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

Exclusion Criteria:

  • absent written consent by parents
  • connatal eye malformation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00799721

Contact: Anke Reinhold, Doctor +49/177/2950661
Contact: Anja Pohl-Schickinger, Doctor +49/30/450566122

Charité Virchow-Hospital Recruiting
Berlin, Germany, 13353
Contact: Anke Reinhold, Doctor   
Sponsors and Collaborators
Charite University, Berlin, Germany

Responsible Party: Dr. Anke Reinhold, Charité University Berlin Identifier: NCT00799721     History of Changes
Other Study ID Numbers: EA2/072/08-1
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: December 1, 2008
Last Verified: August 2008

Keywords provided by Charite University, Berlin, Germany:
very low birth weight infants
retinopathy of prematurity
erythropoietin therapy and risk of ROP

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Epoetin Alfa