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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00799721
First received: November 28, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Development of ROP [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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.


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.

  Eligibility

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • absent written consent by parents
  • connatal eye malformation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799721

Contacts
Contact: Anke Reinhold, Doctor +49/177/2950661 anke.reinhold@charite.de
Contact: Anja Pohl-Schickinger, Doctor +49/30/450566122 anja.pohl@charite.de

Locations
Germany
Charité Virchow-Hospital Recruiting
Berlin, Germany, 13353
Contact: Anke Reinhold, Doctor         anke.reinhold@charite.de    
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Dr. Anke Reinhold, Charité University Berlin
ClinicalTrials.gov Identifier: NCT00799721     History of Changes
Other Study ID Numbers: EA2/072/08-1
Study First Received: November 28, 2008
Last Updated: November 28, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
ROP
VLBW
Epo
IUGR
VEGF
 sFLT-1
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

ClinicalTrials.gov processed this record on May 16, 2013