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Trial record 1 of 7 for:    Baby Fat Pilot
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Measurement of Body Fat in Infants (Baby Fat Pilot)

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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

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.

Condition or disease
Brown Adipose Tissue Body Composition

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Measurement of Body Fat in Infants
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020



Primary Outcome Measures :
  1. whole body adiposity [ Time Frame: 1 day ]
    Whole body adiposity will be measured in infant subjects using dual energy x-ray absorptiometry.

  2. brown adipose tissue [ Time Frame: 1 day ]
    Brown adipose tissue will be measured in infant subjects using magnetic resonance imaging


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490227


Contacts
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Contact: Abby D. Altazan, M.S. 225-763-2801 Abby.Altazan@pbrc.edu

Locations
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United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Abby D Altazan, M.S.    225-763-2801    abby.duhe@pbrc.edu   
Principal Investigator: Leanne M Redman, Ph.D.         
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center

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Responsible Party: Leanne Redman, Assistant Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03490227     History of Changes
Other Study ID Numbers: PBRC 2017-050
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leanne Redman, Pennington Biomedical Research Center:
neonates
brown adipose tissue
body composition