Measurement of Energy Metabolism in Infants (BabyEE Pilot)

Pennington Biomedical Research Center

Status: Enrolling

Conditions: Infant Overnutrition; Infant Development

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02683473

P30DK072476-10 (U.S. NIH Grant/Contract)

PBRC 2015-061

Details and patient eligibility

About

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

Full 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?

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 3 months old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

60 participants in 1 patient group

Infants

Description:

Infants aged 1-3 months