GentleTouch (Study to Evaluate Somatosensory Evoked Potential (SSEP) Responses to Affective Touch and How it Develops in Healthy Term Babies)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Measurement and development of SSEP response to positive touch stimuli
研究概览
简要总结
This study will attempt to measure the direct effect of pleasant skin touch on the developing infant brain. The massage intervention stimulates a specific class of unmyelinated C-fibres in the skin called C-touch (CT) afferents, and effects will be assessed by monitoring brain responses (GentleTouch Project) in a prospective cohort study.
详细描述
This is a single-centre proof of concept translational study to determine how and when Somato-sensory evoked potentials develop over the first 4 months of life.
The aim of this study is to explore if the investigators can measure the cortical response from the scalp of infants using standard non-invasive EEG techniques, due to the activation of CT afferents and explore how the cortical response changes in regard to age. Preform a longitudinal study on 40 subjects at approximately 4 weeks and 4 months of age. The Gentle Touch study will examine the effect of gentle positive stimuli applied to an infant's forearm on cortical responses at two time points within the first 4 months of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 37 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born > 37 weeks gestation
- •Single births
- •Not requiring admission to the Neonatal Unit
- •Healthy infants without suspected congenital or metabolic anomalies
- •Written Informed Consent
排除标准
- •Infants born < 37 weeks gestation
- •Multiple births
- •Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.
- •Admission to the Neonatal Unit.
- •No written Informed Consent obtained
结局指标
主要结局
Measurement and development of SSEP response to positive touch stimuli
时间窗: 4 weeks
Standard Evoked Potentials
次要结局
- Neurodevelopmental Assessment(4 months)
- Measurement of SSEP to positive touch stimuli(4 months)
研究者
Professor Geraldine Boylan
Professor of Neonatal Physiology and Director of INFANT Centre
University College Cork