Measurement of Energy Metabolism in Infants

Infant Development Clinical Trial

— BabyEE Pilot  

Official title:

Measurement of Energy Metabolism in Infants: BabyEE Pilot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02683473
• Other study ID #: PBRC 2015-061
• Secondary ID: P30DK072476-10
• Status: Recruiting
• Start date: March 2016
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Pennington Biomedical Research Center
• Contact: Abby Altazan, M.S.
• Phone: (225) 763-2801
• Email: abby.altazan[@]pbrc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.

Description:

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: 1. 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? 2. What is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study? 3. How do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 3 Months

Eligibility

Inclusion Criteria:

• Healthy, full-term infant
• Aged 1 month (28 days) to 3 months (12 weeks, 6 days) at the first visit
• Exclusively fed breast milk and/or infant formula
• Willing to accept doubly-labeled water

Exclusion Criteria:

• Unable to complete 3 clinic visits within about 14 days at Pennington Biomedical Research Center
• Born preterm (< 37 weeks gestation)
• Congenital abnormality or disability
• Gastric reflux
• Acute illness within 7 days of the study (fever, diarrhea)
• Use of medications to treat a chronic condition (does not include use of vitamin supplements or PRN medication for flatulence or reflux such as Pepcid)

Related Conditions & MeSH terms

• Infant Development
• Infant Nutrition Disorders
• Infant Overnutrition
• Overnutrition

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy Expenditure by infant metabolic chamber	Energy expenditure by infant metabolic chamber measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.	Approximately 1 week
Primary	Energy expenditure by doubly labeled water	Energy expenditure by doubly labeled water measured over 7 days in infants aged 1-3 months	Approximately 1 week
Secondary	Percent body fat	Percent body fat by PEA POD measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.	Approximately 1 week
Secondary	Physical activity counts	Physical activity counts by Actigraph accelerometer measured over 7 days in infants aged 1-3 months.	Approximately 1 week