Body Composition of Infants: Follow-up to Placenta and Co... | NCT01464684

Studies
Body Composition of Infants: Follow-up to Placenta and Cord Blood Analyses

NCT01464684

Sponsor

University of Arkansas

Status

Withdrawn

Last Update Posted

Apr 20, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Infant Body Composition and Metabolism

Interventions

Not provided

Countries

Not provided

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

determined not enough participants would be able to be enrolled and not enough data collected for good analyses

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Oct 31, 2011

First Submission Date that Met QC Criteria

Oct 31, 2011

First Posted Date

Nov 3, 2011Estimated

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

Apr 18, 2017

Last Update Posted Date

Apr 20, 2017Actual

Description Module

Brief Summary

Investigators will characterize the body composition and metabolism of infants born from lean, overweight or obese mothers from whom they had previously obtained a placenta and/or cord blood as part of the earlier placenta and cord blood study (#111576)

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

Retention

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mother's prior participation in study #111576 with successful collection of placenta
infant age 12 months (+/- 9 months)

Exclusion Criteria:

mother did not participate in study #111576
mother did participate in study #111576, but collection of placenta was not successful
infant not age 12 months (+/- 9 months)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

21 Months

Standard Ages

Child

Study Population

infants age 12 months (+/- 9 months)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aline Andres, PhD	University of Arkansas	Principal Investigator

Locations

Not provided