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| Tracking Information | |||||
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| First Received Date ICMJE | November 20, 2005 | ||||
| Last Updated Date | May 12, 2008 | ||||
| Start Date ICMJE | January 2006 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00256906 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome | ||||
| Official Title ICMJE | Isolated Mild Fetal Ventriculomegaly and Neurodevelopmental Outcome | ||||
| 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. |
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| Detailed Description | Study design: Patients:
Methods:
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Retrospective | ||||
| Condition ICMJE | Fetal Development | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | January 2012 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Year to 10 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00256906 | ||||
| Responsible Party | Itai Berger, MD, Hadassah Medical Organization | ||||
| Study ID Numbers ICMJE | IB1205-HMO-CTIL | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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