Measurement of Energy Metabolism in Infants (BabyEE 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02683473|
Recruitment Status : Suspended (Study temporarily paused due to COVID-19 and is expected to resume. This is not a suspension of IRB approval.)
First Posted : February 17, 2016
Last Update Posted : May 4, 2020
|Condition or disease|
|Infant Development Infant Overnutrition|
This study intends to establish the feasibility of undertaking comprehensive metabolic phenotyping in infants. The overarching aim is to complete a prospective assessment of energy expenditure in the new infant metabolic chamber approximately one week apart to determine the accuracy and precision of infant protocols related to energy metabolism (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) and physical activity. This cross-sectional study will answer the following questions:
- What is the test re-test reliability of measuring energy expenditure (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) in an infant under the same conditions, 5-7 days apart?
- What is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study?
- How do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Measurement of Energy Metabolism in Infants: BabyEE Pilot|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Infants aged 1-3 months
- Energy Expenditure by infant metabolic chamber [ Time Frame: Approximately 1 week ]Energy expenditure by infant metabolic chamber measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.
- Energy expenditure by doubly labeled water [ Time Frame: Approximately 1 week ]Energy expenditure by doubly labeled water measured over 7 days in infants aged 1-3 months
- Percent body fat [ Time Frame: Approximately 1 week ]Percent body fat by PEA POD measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.
- Physical activity counts [ Time Frame: Approximately 1 week ]Physical activity counts by Actigraph accelerometer measured over 7 days in infants aged 1-3 months.
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): NCT02683473
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Leanne M Redman, Ph.D.||Pennington Biomedical Research Center|