Preterm Infants With White Matter DamageNCT00564161
VEGF as a Prognostic Factor for White Matter Damage in Preterm Infants
An observational study of Preterm Infants With White Matter Damage and Preterm Infants Developing Normally, run by Hadassah Medical Organization.
Trial summary
We hypothesize that misexpression of vascular endothelial growth factor (VEGF) in the Cerebrospinal fluid of preterm infants can be used as a biomarker to predict the risk for developing white matter damage. Read more about this study
- Who is it for?
- Ages 25 to 40 weeks
- Conditions the study is for
- Preterm Infants With White Matter Damage, Preterm Infants Developing Normally
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Study population: preterm infants.
Who may be able to join
- Preterm infants undergoing lumbar puncture.
Who cannot join
- Preterm with IVH or known infection or meningitis.
About this study
We hypothesize that misexpression of vascular endothelial growth factor (VEGF) in the Cerebrospinal fluid of preterm infants can be used as a biomarker to predict the risk for developing white matter damage.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startJan 2008
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Infants With White Matter DamageStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Talya Dor, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564161
- Sponsor's protocol ID
- 606060-HMO-CTIL
- Other IDs
- 606060-HMO-CTIL
- Status last verified
- Nov 2007
- First submitted
- 25 Nov 2007
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEGF as a Prognostic Factor for White Matter Damage in Preterm Infants
- ClinicalTrials.gov ID
- NCT00564161
- Acronym / sponsor ID
- 606060-HMO-CTIL
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2008
- Study completion
- Jan 2009 (estimated)
- First posted
- 27 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that misexpression of vascular endothelial growth factor (VEGF) in the Cerebrospinal fluid of preterm infants can be used as a biomarker to predict the risk for developing white matter damage.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 25 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- preterm infants.
Key inclusion criteria (1 listed)
- Preterm infants undergoing lumbar puncture.
Key exclusion criteria (1 listed)
- Preterm with IVH or known infection or meningitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talya Dor, MD principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infants With White Matter Damage and Preterm Infants Developing Normally, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.