Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome

NCT ID: NCT00256906

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2012-01-31

Brief 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. 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:

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.

Conditions

Fetal Development

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Itai Berger, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Medical Center

Locations

Itai Berger

Jerusalem, , Israel

Countries

Israel

Other Identifiers

IB1205-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id