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NCT Number: NCT05517967

An Examination of Brown Adipose Tissue and Energy Expenditure in Infants

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.

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Key information

Age range

Up to 5 week

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The developmental origins of obesity begin in utero with growth and differentiation of adipose tissue. Fetal white adipose tissue accretion is highly variable and dependent on the maternal intrauterine environment. Unlike white adipose tissue, brown adipose tissue has a high capacity for thermogenesis. Brown adipose tissue is present at birth and it is believed to support the critical function of thermoregulation in early postnatal life. Therefore, Brown adipose tissue may also influence the development of neonatal energy balance. Similar to white adipose tissue, it is hypothesized that development of Brown adipose tissue in utero is also influenced by maternal factors such as prepregnancy body mass index and gestational weight gain. The research aims of this study to 1) identify maternal and neonatal factors that contribute to neonatal Brown adipose tissue and 2) to identify changes in neonatal Brown adipose tissue and to energy expenditure in response to a mild cold exposure. To achieve these aims, we will conduct a pilot and feasibility study that is cross-sectional, observational study in up to 60 infants 0-3 weeks of age. Using state-of-the-art methodology, we will assess brown adipose tissue, body composition, and resting metabolic rate under thermoneutral and mild-cold stimulated conditions.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Brown Adipose Tissue Fat-signal Fraction Difference Between Thermoneutral and Mild-Cold Environment

    Time frame: 14 days

    The difference in the infants' fat-signal fraction (ratio of lipid to water, expressed as a percentage), assessed by Magnetic Resonance Imaging, between a thermoneutral environment and a mild-cold exposure.

  2. Energy Expenditure Difference Between Thermoneutral and Mild-Cold Environment

    Time frame: 14 days

    The difference in the infants' energy expenditure (expressed as kilocalories per day), assessed by room calorimetry, between a thermoneutral environment and a mild-cold exposure.

Study contacts

Contact information is provided by the study sponsor or research team.

Abby D Altazan, MS

CONTACT

[email protected]

225-763-2801

Emily W Flanagan, PhD

CONTACT

[email protected]

225-763-2828

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: Born2Burn

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2022
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.