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Measurement of Energy Metabolism in Infants

Measurement of Energy Metabolism in Infants: BabyEE Pilot

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02683473
Acronym
BabyEE Pilot
Enrollment
70
Registered
2016-02-17
Start date
2016-03-16
Completion date
2027-06-30
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Development, Infant Overnutrition

Brief summary

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

Detailed 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?

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Months to 3 Months
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Energy Expenditure by infant metabolic chamberApproximately 1 weekEnergy 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 waterApproximately 1 weekEnergy expenditure by doubly labeled water measured over approximately 7 days in infants aged 1-3 months

Secondary

MeasureTime frameDescription
Percent body fatApproximately 1 weekPercent body fat by PEA POD measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.
Physical activity countsApproximately 1 weekPhysical activity counts by Actigraph accelerometer measured over approximately 7 days in infants aged 1-3 months.

Countries

United States

Contacts

CONTACTAbby Altazan, M.S.
abby.altazan@pbrc.edu(225) 763-2801
PRINCIPAL_INVESTIGATORLeanne M Redman, Ph.D.

Pennington Biomedical Research Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026