Brain Organization, Development, and Response to Intervention in Individual Neonates
概览
- 阶段
- 不适用
- 干预措施
- Neonatal Massage
- 疾病 / 适应症
- Development, Infant
- 发起方
- Washington University School of Medicine
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change in correlated brain activity among functional brain areas in the somatomotor cortex
- 状态
- 招募中
- 最后更新
- 昨天
概览
简要总结
The goal of this study is to learn about brain connectivity and if massaging babies shortly after birth has an impact. Half of the recruited babies will receive massage daily while the other half will not, and differences will be observed.
研究者
入排标准
入选标准
- •English speaking
- •Ability to give informed consent
排除标准
- •Prisoners (vulnerable population)
- •Pregnant women \<18 years of age
- •Active psychosis, mania, suicidal ideation (safety)
- •Active substance dependence
- •Gestational Age \<35 weeks (neonates)
- •Neonatal encephalopathy (neonates)
研究组 & 干预措施
Neonatal Massage Received
干预措施: Neonatal Massage
No Massage Received
结局指标
主要结局
Change in correlated brain activity among functional brain areas in the somatomotor cortex
时间窗: up to 3 months
Brain activity is measured across the brain with functional magnetic resonance imaging (fMRI) before and after the intervention. The timeseries of brain activity will be extracted from each of the subject-specific parcels of the somatomotor network (SMN). Parcels will be divided into those that represent the upper versus lower extremity. The average of the pairwise correlations in the timeseries between upper and lower extremity parcels is the "cross-effector SMN functional connectivity" that is the primary measure. This measure will be computed before and after the intervention; we predict a decrease in cross-effector SMN functional connectivity following the intervention.