Brain Organization, Development, and Response to Intervention in Individual Neonates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
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 (Behavioral)
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.
次要结局
未报告次要终点