Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome

March 4, 2018 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

Study design:

Patients:

  1. All children who are currently 5-6 year-old who suffered from isolated fetal mild brain ventriculomegaly during the pregnancy.
  2. 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:

  1. 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.
  2. All children will be assessed by a psychologist who will perform WIPPSI or BAYLEY tests according to age.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91240
        • Itai Berger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Anatomic malformations
  • IVH
  • Hydrocephalus
  • Metabolic disorder
  • CNS infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Itai Berger, MD, Hadassah University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 20, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 4, 2018

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IB1205-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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