Breast Versus Bottle Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Infant Intake During the Observed Feeding (mL)
研究概览
简要总结
The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of feeding mode (breast- versus bottle-feeding) on the quality and outcome of infant feeding interactions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 0 Weeks 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mothers 18-40 years of age
- •Infants 0-24 weeks of age
- •Infants who have not yet been introduced to complementary foods and beverages
- •Dyads are breast- and bottle-feeding
- •Mother is predominantly or solely responsible for infant feeding
排除标准
- •preterm birth (i.e., gestational age <37 weeks)
- •low birth weight (<2500 g)
- •maternal smoking during pregnancy
- •current or past medical conditions that interfere with oral feeding
- •history of slow growth or failure to thrive
- •weight for length percentile <5th
- •diagnosed developmental delay (e.g., Down's syndrome)
结局指标
主要结局
Infant Intake During the Observed Feeding (mL)
时间窗: 2-hour period
For both breast- and bottle-feedings, infant intake will be assessed by pre- and post-weighing the baby on an infant scale (model 374; Seca, Hamburg, Germany). During bottle-feedings, we will also note whether the infant finishes the bottle.
Maternal Sensitivity to Infant Cues
时间窗: 2-hour period
Mother and infant behavior during each feeding will be coded using the Nursing Child Assessment Parent-Child Interaction - Feeding Scale (NCAFS). This scale contains six subscales, four of which describe maternal attributes (Sensitivity to Cues, Response to Child's Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering) and two of which describe infant attributes (Clarity of Cues and Responsiveness to Caregiver). The proposed analysis will focus on the Sensitivity to Cues subscale, which measures the degree to which the mother is able to understand and respond to her child's cues. This scale provides a global measure of how sensitive the mother is to the infant's needs during the feeding interaction. Possible score range is 0-16, which is derived from summing together maternal scores for each of the 16 subscale items. Higher scores indicate greater sensitivity to infant cues.
次要结局
未报告次要终点
研究者
Alison Ventura
Associate Professor
California Polytechnic State University-San Luis Obispo