Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome - Full Text View

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00256906

Purpose

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.

Condition
Fetal Development

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment:	200
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	1 Year to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children up to the age of 10 years who were diagnosed with isolated mild ventriculomegaly as fetuses

Criteria

Inclusion Criteria:

All children who were or are diagnosed with isolated fetal mild ventriculomegaly

Exclusion Criteria:

Anatomic malformations
IVH
Hydrocephalus
Metabolic disorder
CNS infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256906

Locations

Israel
Itai Berger
Jerusalem, Israel, 91240

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Itai Berger, MD

Hadassah University Medical Center

More Information

No publications provided

Responsible Party:	Itai Berger, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00256906 History of Changes
Other Study ID Numbers:	IB1205-HMO-CTIL
Study First Received:	November 20, 2005
Last Updated:	May 12, 2008
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

lateral ventricles
fetal ventriculomegaly

Additional relevant MeSH terms:

Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on February 13, 2012