N/A
N=10
Measurement of Body Fat in Infants
Brown Adipose Tissue · Body Composition
Bottom Line
View on ClinicalTrials.gov: NCT03490227 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Whole Body Fat Mass — 20.8 percentage of fat mass
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole Body Fat Mass |
20.8 | — |
| PRIMARY Average Brown Adipose Tissue Volume at First Visit |
5.41 | — |
| PRIMARY Average Brown Adipose Tissue Volume at Second Visit |
5.50 | — |
| SECONDARY Average Fat Signal Fraction of Brown Adipose Tissue at First Visit |
16.64 | — |
| SECONDARY Average Fat Signal Fraction of Brown Adipose Tissue at Second Visit |
16.43 | — |
| SECONDARY Reliability of Average Brown Adipose Tissue Volume Measurement Between the First and Second Visit |
0.92 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03490227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.