RecruitingNot Applicable

Measurement of Energy Metabolism in Infants

United States70 participantsStarted 2016-03-16

Plain-language summary

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

Who can participate

Age range

1 Month – 3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Energy Expenditure by infant metabolic chamber

Timeframe: Approximately 1 week

Energy expenditure by doubly labeled water

Timeframe: Approximately 1 week

Trial details

NCT IDNCT02683473

SponsorPennington Biomedical Research Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06-30

Contact for this trial

Abby Altazan, M.S.

(225) 763-2801 abby.altazan@pbrc.edu

View on ClinicalTrials.gov More Infant Development trials

Who can participate

Age range

1 Month – 3 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.