Serial Assessment of Body Fat Accrual in Very Preterm Infants: A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Infant Body Composition
研究概览
简要总结
Despite evidence that both rapid weight gain and excessive body fat accrual are associated with overweight and obesity, usual neonatal care of preterm infants does not include assessment of body fat accrual. The study hypothesis is that identification of early changes in infant body composition (i.e. amount of fat mass and fat-free mass) reduces % body fat at 3 months of age.
详细描述
Infants in the intervention group will have the information about infant body composition known to the clinicians caring for them (including reference data). Infants in the control group will also undergo serial measurements of infant body composition, but this information will not be available to the clinicians.
If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 28 and 32 weeks of gestation
排除标准
- •Gastrointestinal or neurologic malformations
- •Terminal illness requiring limited or withheld support
结局指标
主要结局
Infant Body Composition
时间窗: Assessed at 3 months of corrected age
Percent body fat estimated by air displacement plethysmography
次要结局
- Growth(Birth to 3 months of corrected age)
- Length(3 months of corrected age)
- Head Circumference(3 months of corrected age)
- Body Mass Index(3 months of corrected age)
- Infant Body Composition(Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first))
研究者
Ariel A. Salas
Assistant Professor
University of Alabama at Birmingham