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Measurement of Body Fat in Infants (Baby Fat Pilot)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490227
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center

Tracking Information
First Submitted Date March 29, 2018
First Posted Date April 6, 2018
Last Update Posted Date October 28, 2019
Actual Study Start Date April 30, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2018)
  • whole body adiposity [ Time Frame: 1 day ]
    Whole body adiposity will be measured in infant subjects using dual energy x-ray absorptiometry.
  • brown adipose tissue [ Time Frame: 1 day ]
    Brown adipose tissue will be measured in infant subjects using magnetic resonance imaging
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 4, 2018)
precision of brown adipose tissue measurement [ Time Frame: 2 days within 10 days apart ]
Brown adipose tissue by magnetic resonance imaging will be measured twice within 10 days apart to assess the precision of the measurement protocol.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measurement of Body Fat in Infants
Official Title Measurement of Body Fat in Infants
Brief Summary Up to 10 infants will complete the study aimed to establish a technique for measuring whole body adiposity and brown adipose tissue in infant subjects using dual energy x-ray absorptiometry and magnetic resonance imaging, respectively.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Up to 10 healthy, full term infants aged 14 to 28 days old at enrollment with no contraindications to MRI will be recruited to Pennington Biomedical Research Center to participate in this study which includes two study visits to be completed within 1-10 days apart.
Condition
  • Brown Adipose Tissue
  • Body Composition
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 Recruiting
Estimated Enrollment
 (submitted: April 4, 2018)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • healthy, full-term infant
  • aged 14-28 days at Visit 1

Exclusion Criteria:

  • born preterm (<37 weeks gestation)
  • implanted metal or electronic objects that render MRI unsafe
  • unable to complete 2 clinic visits 1-10 days apart at Pennington Biomedical Research Center
Sex/Gender
Sexes Eligible for Study: All
Ages up to 28 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Abby D. Altazan, M.S. 225-763-2801 Abby.Altazan@pbrc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03490227
Other Study ID Numbers PBRC 2017-050
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Leanne Redman, Pennington Biomedical Research Center
Study Sponsor Pennington Biomedical Research Center
Collaborators Not Provided
Investigators
Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center
PRS Account Pennington Biomedical Research Center
Verification Date October 2019