NCT07665983招募中不适用
Managing Excess Infant Energy Intake by Increasing Satiation Responsiveness in Dyadic Feeding Interactions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 1
研究概览
简要总结
The researchers will study how babies respond to bottle nipples with different flow rates over a few days, and how this may affect how much milk they drink, their feeding patterns, and their sleep.
详细描述
The study will enroll 220 mother-infant dyads.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother-infant dyad: The biological mother is the legal guardian of the infant and has custody for ≥5 days per week (in cases of joint custody).
- •Maternal age: Mother is ≥18 years old.
- •Language: Mother understands spoken and written English sufficiently to provide informed consent, answer questionnaires and follow study instructions.
- •Gestational age: Infant was born at 37.0-42.0 weeks gestation.
- •Birthweight: Infant's birthweight was appropriate for gestational age.
- •Bottle feeding: Infant currently receives at least one bottle feeding of ≥2 ounces at least once per week.
- •Residence: Family lives within approximately one hours driving distance of Ann Arbor, Michigan to participate in an at- home appointment or is willing to drive to the U-M North Campus research site.
- •Infant age: Infant is 4.0-6.0 months old at enrollment.
排除标准
- •Current maternal depression or anxiety, as assessed by screening questionnaires, or any cognitive impairment that would limit ability to follow study instructions.
- •Infant developmental delay, genetic condition, or medical problems or diagnosis affecting current or future eating, growth, or development.
- •History of significant sucking or feeding difficulties or breastfeeding difficulties requiring significant medical intervention or support.
- •Current weight-for-age below the 10th percentile or significant history of poor weight gain.
- •Infant already typically uses a slower-flow nipple (flow rate < 5 mL/min).
研究组 & 干预措施
Mother-infant dyad
Experimental
Each mother-infant dyad serves as its own control.
干预措施: Feeding (Behavioral)
研究者
Amanda Kinney Crandall
Research Investigator
University of Michigan
研究点 (1)
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