Measurement of Energy Metabolism in Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infant Development, Infant Overnutrition. Basic parameters: 1 months — 3 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Measurement of Energy Metabolism in Infants: BabyEE Pilot
Overview
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?
Primary outcome measures
- Energy Expenditure by infant metabolic chamber [Time frame: Approximately 1 week]
- Energy expenditure by doubly labeled water [Time frame: Approximately 1 week]
Secondary outcome measures (2)
- Percent body fat [Time frame: Approximately 1 week]
- Physical activity counts [Time frame: Approximately 1 week]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Pennington Biomedical Research Center — Baton Rouge
Identifiers
NCT: NCT02683473 · PBRC 2015-061 · P30DK072476-10