Fetal DevelopmentNCT00256906
Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome
An observational study of Fetal Development, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Isolated mild fetal ventriculomegaly is a common finding in fetal ultrasound examinations. When the ventricular diameter is more than 15 mm it is usually considered as severe and connected to other malformations. Most of these children will be severely affected later in life. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Fetal Development
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2006to Jan 2012
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children up to the age of 10 years who were diagnosed with isolated mild ventriculomegaly as fetuses
Who may be able to join
- All children who were or are diagnosed with isolated fetal mild ventriculomegaly
Who cannot join
- Anatomic malformations
- IVH
- Hydrocephalus
- Metabolic disorder
- CNS infection
Trial locations and contacts
1 site in 1 country.
About this study
Isolated mild fetal ventriculomegaly is a common finding in fetal ultrasound examinations.
When the ventricular diameter is more than 15 mm it is usually considered as severe and connected to other malformations. Most of these children will be severely affected later in life. Less than 10 mm ventricular width considered as normal.
Read more
The current medical knowledge can not answer questions regarding future development of children who were diagnosed to suffer from mild (10-14.9 mm) brain ventriculomegaly during the pregnancy.
We would like to assess the development and neurological status of all children who were diagnosed as "mild ventriculomegaly" during the pregnancy in the last 6 years and to prospectively follow up all the children who will be diagnosed from the beginning of the study on for 6 years.
We hypothesized that the course of their development is different than of other children.
Read the detailed description
Study design:
Patients:
- All children who are currently 5-6 year-old who suffered from isolated fetal mild brain ventriculomegaly during the pregnancy.
- All children who will be diagnosed with isolated fetal mild brain ventriculomegaly during the pregnancy from the beginning of the study for 6 years.
Methods:
- All children will be examined by a pediatric neurologist who will perform a neuro-developmental assessment appropriate for age. The neurologist will decide individually whether there is a need for more medical tests.
- All children will be assessed by a psychologist who will perform WIPPSI or BAYLEY tests according to age.
- Conditions
- Fetal Development
- Keywords
- lateral ventricles, fetal ventriculomegaly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startJan 2006
- Primary completionDec 2010
- Study completionJan 2012
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DevelopmentStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Itai Berger, MD, Principal investigator, Hadassah University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256906
- Sponsor's protocol ID
- IB1205-HMO-CTIL
- Status last verified
- Jun 2007
- First submitted
- 20 Nov 2005
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome
- ClinicalTrials.gov ID
- NCT00256906
- Acronym / sponsor ID
- IB1205-HMO-CTIL
- Conditions
- Fetal Development
- Keywords
- lateral ventricles, fetal ventriculomegaly
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Nov 2005 (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.
Isolated mild fetal ventriculomegaly is a common finding in fetal ultrasound examinations.
When the ventricular diameter is more than 15 mm it is usually considered as severe and connected to other malformations. Most of these children will be severely affected later in life. Less than 10 mm ventricular width considered as normal.
The current medical knowledge can not answer questions regarding future development of children who were diagnosed to suffer from mild (10-14.9 mm) brain ventriculomegaly during the pregnancy.
We would like to assess the development and neurological status of all children who were diagnosed as "mild ventriculomegaly" during the pregnancy in the last 6 years and to prospectively follow up all the children who will be diagnosed from the beginning of the study on for 6 years.
We hypothesized that the course of their development is different than of other children.
Detailed description
Study design:
Patients:
- All children who are currently 5-6 year-old who suffered from isolated fetal mild brain ventriculomegaly during the pregnancy.
- All children who will be diagnosed with isolated fetal mild brain ventriculomegaly during the pregnancy from the beginning of the study for 6 years.
Methods:
- All children will be examined by a pediatric neurologist who will perform a neuro-developmental assessment appropriate for age. The neurologist will decide individually whether there is a need for more medical tests.
- All children will be assessed by a psychologist who will perform WIPPSI or BAYLEY tests according to age.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children up to the age of 10 years who were diagnosed with isolated mild ventriculomegaly as fetuses
Key inclusion criteria (1 listed)
- All children who were or are diagnosed with isolated fetal mild ventriculomegaly
Key exclusion criteria (5 listed)
- Anatomic malformations
- IVH
- Hydrocephalus
- Metabolic disorder
- CNS infection
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 stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
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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.
Itai Berger, MD principal investigator
Hadassah University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Development, run by Hadassah Medical Organization at 1 site in Israel.
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 5 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: stopped early, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: lack of funding). Results are not available in the source record.
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 6 Mar 2018.