Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome

Fetal Development Clinical Trial

Official title:

Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00256906
• Other study ID #: IB1205-HMO-CTIL
• Status: Terminated
• Phase: N/A
• First received: November 20, 2005
• Last updated: March 4, 2018
• Start date: January 2006
• Est. completion date: January 2012

Study information

• Verified date: June 2007
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Anatomic malformations

• IVH

• Hydrocephalus

• Metabolic disorder

• CNS infection

Related Conditions & MeSH terms

• Fetal Development
• Hydrocephalus

Locations

Country	Name	City	State
Israel	Itai Berger	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel,