Correlation of Volumetric Brain Analysis With Development... | NCT00194831

Studies
Correlation of Volumetric Brain Analysis With Development at 18 Months

NCT00194831

Sponsor

Weill Medical College of Cornell University

Status

Withdrawn

Last Update Posted

Jun 15, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Child Development

Interventions

Not provided

Countries

United States

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No data. Study never completed.

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 19, 2005Estimated

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

Jun 11, 2015

Last Update Posted Date

Jun 15, 2015Estimated

Description Module

Brief Summary

The study will correlate the volumes of the brain obtained from magnetic resonance imaging (MRI) scans done at term gestation for infants born prematurely who weighed less than 1000 grams at birth with their corresponding development at 18 months corrected age.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All premature infants born < 1000 grams who had MRI scans of the brain at term gestation

Exclusion Criteria:

Any known genetic or chromosomal abnormalities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

2 Years

Standard Ages

Child

Study Population

Premature infants < 1000 gram birthweight who are followed post discharge as part of standard clinical care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey M Perlman, MB	New York Presbyterian Hospital Weill Cornell	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Presbyterian Hospital Weill Cornell		New York	New York	10021	United States