Urine VEGF Levels in Very Low Birth Weight (VLBW) Infants | NCT00799721

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

NCT00799721

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Dec 1, 2008Estimated

Enrollment

160Estimated

Phase

Not provided

Conditions

Infant, Very Low Birth Weight

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Feb 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Nov 28, 2008

First Submission Date that Met QC Criteria

Nov 28, 2008

First Posted Date

Dec 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2008

Last Update Posted Date

Dec 1, 2008Estimated

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		VLBW infants with erythropoietin therapy
2		VLBW infants without erythropoietin therapy.

Interventions

Not provided

Measure	Description	Time Frame
Development of ROP		4 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

gestational age < 32 weeks
birth weight <1500g

Exclusion Criteria:

absent written consent by parents
connatal eye malformation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

32 Weeks

Standard Ages

Child

Study Population

Pretarem infants of less than 32 weeks of gestation or birth weight below 1500g.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anke Reinhold, Doctor	Contact	+49/177/2950661		anke.reinhold@charite.de
Anja Pohl-Schickinger, Doctor	Contact	+49/30/450566122		anja.pohl@charite.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Virchow-Hospital	Recruiting	Berlin	State of Berlin	13353	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012178	Retinopathy of Prematurity

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases

Browse Leaves

Not provided

Browse Branches

Not provided