Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Whole Body Fat Mass | Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry. | 1 day |
| Average Brown Adipose Tissue Volume at First Visit | Magnetic resonance imaging were traced for lipid: water ratio in the supraclavicular region. Brown adipose tissue volume was calculated by summing all brown adipose tissue volume in the supraclavicular region with a lipid: water ration (or fat signal fraction) between 10-50%. | 1 day |
| Average Brown Adipose Tissue Volume at Second Visit | Magnetic resonance imaging were traced for lipid: water ratio in the supraclavicular region. Brown adipose tissue volume was calculated by summing all brown adipose tissue volume in the supraclavicular region with a lipid: water ration (or fat signal fraction) between 10-50%. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Average Fat Signal Fraction of Brown Adipose Tissue at First Visit | Magnetic resonance imaging scans were traced for lipid: water ratio in the supraclavicular region. Fat signal fraction is defined as the lipid: water ratio found in the lipid tissues in the supraclavicular region. Only traced lipid tissues (between 10-50%) were included in the average fat signal fraction because only traced lipid tissues were classified as brown adipose tissue. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leanne M Redman, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | This is an observational study where all participants did DXA once and MRI twice in order to assess infant body composition and brown adipose tissue. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This is an observational study where all participants did DXA once and MRI twice in order to assess infant body composition and brown adipose tissue. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Whole Body Fat Mass | Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry. | Posted | Mean | Standard Deviation | percentage of fat mass | 1 day |
|
|
10 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | This is an observational study where all participants did DXA once and MRI twice in order to assess infant body composition and brown adipose tissue. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
During one MRI scan occurring at the respective participant's first visit, a magnetic resonance imaging (MRI) machine malfunction led to acquisition of images that were unanalyzable and therefore unusable.
The study is limited by a small and relatively homogenous sample of ten infants. Given the nature of the method development study, we did not enroll equal numbers of males and females.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leanne Redman | Pennington Biomedical Research Center | 225-763-0947 | leanne.redman@pbrc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2018 | Aug 6, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
| 1 day |
| Average Fat Signal Fraction of Brown Adipose Tissue at Second Visit | Magnetic resonance imaging scans were traced for lipid: water ratio in the supraclavicular region. Fat signal fraction is defined as the lipid: water ratio found in the lipid tissues in the supraclavicular region. Only traced lipid tissues (between 10-50%) were included in the average fat signal fraction because only traced lipid tissues were classified as brown adipose tissue. | 1 day |
| Reliability of Average Brown Adipose Tissue Volume Measurement Between the First and Second Visit | Reliability of average brown adipose tissue volume measurement between visits was determined using intraclass correlation coefficient. Paired average brown adipose tissue volume measurements were included in the intraclass correlation coefficient computation. | 2 days within 10 days apart |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Gestational Age at Birth | Mean | Standard Deviation | weeks |
|
|
| Primary | Average Brown Adipose Tissue Volume at First Visit | Magnetic resonance imaging were traced for lipid: water ratio in the supraclavicular region. Brown adipose tissue volume was calculated by summing all brown adipose tissue volume in the supraclavicular region with a lipid: water ration (or fat signal fraction) between 10-50%. | One scan was not analyzed. The scan was completed but did not provide valid data. | Posted | Mean | Standard Deviation | cubic centimeters | 1 day |
|
|
|
| Primary | Average Brown Adipose Tissue Volume at Second Visit | Magnetic resonance imaging were traced for lipid: water ratio in the supraclavicular region. Brown adipose tissue volume was calculated by summing all brown adipose tissue volume in the supraclavicular region with a lipid: water ration (or fat signal fraction) between 10-50%. | Posted | Mean | Standard Deviation | cubic centimeters | 1 day |
|
|
|
| Secondary | Average Fat Signal Fraction of Brown Adipose Tissue at First Visit | Magnetic resonance imaging scans were traced for lipid: water ratio in the supraclavicular region. Fat signal fraction is defined as the lipid: water ratio found in the lipid tissues in the supraclavicular region. Only traced lipid tissues (between 10-50%) were included in the average fat signal fraction because only traced lipid tissues were classified as brown adipose tissue. | One scan was not analyzed. The scan was completed but did not provide valid data. | Posted | Mean | Standard Deviation | Percentage of lipid | 1 day |
|
|
|
| Secondary | Average Fat Signal Fraction of Brown Adipose Tissue at Second Visit | Magnetic resonance imaging scans were traced for lipid: water ratio in the supraclavicular region. Fat signal fraction is defined as the lipid: water ratio found in the lipid tissues in the supraclavicular region. Only traced lipid tissues (between 10-50%) were included in the average fat signal fraction because only traced lipid tissues were classified as brown adipose tissue. | Posted | Mean | Standard Deviation | Percentage of lipid | 1 day |
|
|
|
| Secondary | Reliability of Average Brown Adipose Tissue Volume Measurement Between the First and Second Visit | Reliability of average brown adipose tissue volume measurement between visits was determined using intraclass correlation coefficient. Paired average brown adipose tissue volume measurements were included in the intraclass correlation coefficient computation. | One scan was not analyzed. The scan was completed but did not provide valid data. | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient | 2 days within 10 days apart |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
Not provided
Not provided