Measurement of Energy Metabolism in Infants: BabyEE Pilot
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Energy Expenditure by infant metabolic chamber
研究概览
简要总结
The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.
详细描述
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:
- 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?
- What is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study?
- How do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Month 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Infants
Infants aged 1-3 months
结局指标
主要结局
Energy Expenditure by infant metabolic chamber
时间窗: Approximately 1 week
Energy expenditure by infant metabolic chamber measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.
Energy expenditure by doubly labeled water
时间窗: Approximately 1 week
Energy expenditure by doubly labeled water measured over approximately 7 days in infants aged 1-3 months
次要结局
- Percent body fat(Approximately 1 week)
- Physical activity counts(Approximately 1 week)
研究者
Leanne Redman
Principal Investigator
Pennington Biomedical Research Center