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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00256906 |
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.
Condition |
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Fetal Development |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome |
Estimated Enrollment: | 200 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Study design:
Patients:
Methods:
Ages Eligible for Study: | 1 Year to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Children up to the age of 10 years who were diagnosed with isolated mild ventriculomegaly as fetuses
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hadassah Medical Organization ( Itai Berger, MD ) |
Study ID Numbers: | IB1205-HMO-CTIL |
Study First Received: | November 20, 2005 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00256906 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
lateral ventricles fetal ventriculomegaly |
Pseudotumor Cerebri Infant, Newborn, Diseases Central Nervous System Diseases Hydrocephalus |
Brain Diseases Intracranial Hypertension Hypertension |
Nervous System Diseases Infant, Newborn, Diseases Central Nervous System Diseases |
Hydrocephalus Brain Diseases Intracranial Hypertension |