Measuring energy metabolism in infants
Measurement of Energy Metabolism in Infants: BabyEE Pilot
Pennington Biomedical Research Center · NCT02683473
This study is testing a new way to measure how much energy healthy newborns use in their first three months to better understand their growth and metabolism.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 1 Month to 3 Months |
| Sex | All |
| Sponsor | Pennington Biomedical Research Center (other) |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT02683473 on ClinicalTrials.gov |
What this trial studies
This study aims to measure energy expenditure in healthy, full-term infants during their first three months of life. It will assess the reliability of various energy metabolism measurements, including sleeping metabolic rate and resting metabolic rate, using a new infant metabolic chamber. The study will involve multiple visits to evaluate the accuracy of these measurements and how they relate to infant size and body composition. By establishing these protocols, the research seeks to enhance our understanding of infant energy metabolism.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy, full-term infants aged 1 month to 3 months who are exclusively fed breast milk or infant formula.
Not a fit: Patients who may not benefit from this study include those with congenital abnormalities, disabilities, or acute illnesses, as well as preterm infants.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into infant energy metabolism, potentially guiding interventions for infant overnutrition and development.
How similar studies have performed: While this approach is relatively novel, previous studies have explored energy metabolism in infants, but comprehensive metabolic phenotyping in this specific manner is less common.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Baton Rouge, Louisiana
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (RECRUITING)
Study contacts
- Principal investigator: Leanne M Redman, Ph.D. — Pennington Biomedical Research Center
- Study coordinator: Abby Altazan, M.S.
- Email: abby.altazan@pbrc.edu
- Phone: (225) 763-2801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infant Development, Infant Overnutrition