NCT00256906

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 6, 2018

Status Verified

June 1, 2007

Enrollment Period

4.9 years

First QC Date

November 20, 2005

Last Update Submit

March 4, 2018

Conditions

Fetal Development

Keywords

lateral ventriclesfetal ventriculomegaly

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Itai Berger

Jerusalem, 91240, Israel

Location

Study Officials

  • Itai Berger, MD

    Hadassah University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2005

First Posted

November 22, 2005

Study Start

January 1, 2006

Primary Completion

December 1, 2010

Study Completion

January 1, 2012

Last Updated

March 6, 2018

Record last verified: 2007-06

Locations

IL(1)