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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01464684
Recruitment Status : Withdrawn (determined not enough participants would be able to be enrolled and not enough data collected for good analyses)
First Posted : November 3, 2011
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date October 31, 2011
First Posted Date November 3, 2011
Last Update Posted Date April 20, 2017
Study Start Date October 2011
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Body Composition of Infants: Follow-up to Placenta and Cord Blood Analyses
Official Title Body Composition of Infants: Follow-up to Placenta and Cord Blood Analyses
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine, and a cheek swab may be collected from study participants
Sampling Method Non-Probability Sample
Study Population infants age 12 months (+/- 9 months)
Condition Infant Body Composition and Metabolism
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: April 30, 2012)
0
Original Estimated Enrollment
 (submitted: October 31, 2011)
60
Estimated Study Completion Date December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Months to 21 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT01464684
Other Study ID Numbers 132624
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Arkansas
Study Sponsor University of Arkansas
Collaborators Not Provided
Investigators
Principal Investigator: Aline Andres, PhD University of Arkansas
PRS Account University of Arkansas
Verification Date April 2017