NCT01121523已完成不适用
Effect of Cue-based Tactile Stimulation on Premature, Low Birth Weight Infants: Stress Reactivity.Immune Functioning, and Parenting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Stress reactivity
研究概览
简要总结
The present study is an examination of cue-directed tactile stimulation (CTDS), administered by mothers and NICU nurses, on infant and maternal stress reactivity, infant immune system functioning, maternal parenting cognitions, and parenting competence.
详细描述
The overarching aim of this study is to assess the effects of a program of mother-delivered, cue-based infant massage on stress reactivity in the mother-infant dyad, and on other measures of mother-infant functioning. The study has several interrelated objectives:
- To evaluate the short-term effects of infant massage intervention on infant and maternal stress reactivity from assays of maternal and infant salivary cortisol, and cortisol levels in mothers' breast milk.
- To examine the impact of mother-delivered infant massage on the development of infant resistance to infectious pathogens and antibody-based protective immunity in response to routine scheduled vaccinations, and to examine if the degree of immunity is mediated by infant stress reactivity.
- To examine the impact of mother-delivered infant massage, and of changes in stress reactivity in response to massage, on infant physiological functioning (vagal tone, heart rate variability), infant physical development (weight, height, and head circumference), mothers' perception of infant temperament and infant state regulation, parenting self-efficacy, symptoms of depression and anxiety, and mother-infant interaction.
- To examine associations between cortisol levels in mothers' saliva, mothers' breast milk, and infants' saliva. Establishing such linkages would support recent animal data suggesting that infant glucocorticoid levels can be affected by glucocorticoid levels transferred to the infant in mother's milk.
- To examine whether a single nucleotide polymorphism (SNP) in three candidate genes (Mu opioid receptor, brain-derived neurotropic factor, and vasopressin V1b receptor), each associated with hypothalamic-pituitary-adrenal axis (HPA) functioning, moderates the effects of infant massage on stress-related outcomes.
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
- 7 Days 至 4 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •The following babies will be excluded:
- •With any chromosomal abnormality
- •With congenital heart disease
- •With any surgical intervention
- •With intraventricular hemorrhages greater than grade II
- •If mother dies during delivery
结局指标
主要结局
Stress reactivity
时间窗: one month post-intervention
Infant and maternal salivary cortisol
次要结局
- Infant immune functioning(2-3 months post-intervention)
研究者
Douglas M. Teti
Professor of Human Development
Penn State University
研究点 (2)
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