Outcome of Babies With Asymetry of Lateral Brain Ventricles | NCT01724281

Studies
Outcome of Babies With Asymetry of Lateral Brain Ventricles

NCT01724281

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Nov 9, 2012Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Lateral Ventricles of Fetuses at Mid Trimester

Interventions

No intervention, only follow up

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Nov 6, 2012

First Submission Date that Met QC Criteria

Nov 8, 2012

First Posted Date

Nov 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2012

Last Update Posted Date

Nov 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will follow up on babies that had prenatal diagnosis at 2nd or 3rd trimester of normal width and asymetry of lateral brain ventricles

Detailed Description

Women who will attend 2nd or 3rd ultrasound prenatal scans will be included. Women where the fetus would be diagnosed with lateral ventricles that are normal width (<10 m"m) but discrepacy of >3 m"m will be followed up after delivery by head ultrasound and neurologic exam

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pregnant women between 19-30 weeks gestational age		No intervention, only follow up	Other: No intervention, only follow up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention, only follow up	Other		pregnant women between 19-30 weeks gestational age

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lateral ventricles width after delivery	The investigators will follow up on brain ultrasound of babies with normal width discrepant lateral brain ventricles	2 years

Secondary Outcomes

Measure	Description	Time Frame
Neurologic examination of babies with discrepant but normal lateral ventricles	After delivery, a neurologic examination will be carried out on all babies with discrepant but normal lateral ventricles	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy pregnant women between 19-30 weeks gestational age and asymetry of lateral ventricles

Exclusion Criteria:

Lateral ventricles >10 m"m

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

women at 19-30 weeks who attend ultrasound exam and diagnosed with asymetry of lateral brain ventricles.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alon Shrim, MD	Contact	+972506246988		alon.shrim@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38101	Israel