Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Hadassah Medical Organization.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00256906
First received: November 20, 2005
Last updated: May 12, 2008
Last verified: June 2007

November 20, 2005
May 12, 2008
January 2006
December 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00256906 on ClinicalTrials.gov Archive Site
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Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome
Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome

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 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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

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

Fetal Development
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
January 2012
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Anatomic malformations
  • IVH
  • Hydrocephalus
  • Metabolic disorder
  • CNS infection
Both
1 Year to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00256906
IB1205-HMO-CTIL
No
Itai Berger, MD, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Itai Berger, MD Hadassah University Medical Center
Hadassah Medical Organization
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP