An Examination of Brown Adipose Tissue and Energy Expenditure in Infants (NCT05517967) | Clinical Trial Compass
RecruitingNot Applicable
An Examination of Brown Adipose Tissue and Energy Expenditure in Infants
United States60 participantsStarted 2022-08-17
Plain-language summary
Excess fetal adipose tissue growth during intrauterine development increases future obesity risk. Development of brown adipose tissue, a highly thermogenic organ in utero, may affect postnatal energy expenditure, thus influencing obesity risk. This pilot research study is designed to understand the developmental origins of energy balance by examining maternal and neonatal factors that influence neonatal brown adipose tissue and to quantify its physiological relevance to energy expenditure in human neonates.
Who can participate
Age range
5 Weeks
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:
* aged 0 weeks to less than 3 weeks at visit 1
* be willing to complete MRI procedures
Exclusion Criteria:
* Unable to complete two clinic visits within 14 days
* Born with health conditions that would render the procedures unsafe
* Born earlier than 36 and 0 days gestation
* Taken a steroid drug since birth
* Implanted metal or electronic objects that render MRI unsafe
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
1
Brown Adipose Tissue Fat-signal Fraction Difference Between Thermoneutral and Mild-Cold Environment
Timeframe: 14 days
2
Energy Expenditure Difference Between Thermoneutral and Mild-Cold Environment