Movement Imitation Therapy v/s Standard Care in Very Preterm and Extreme Preterm Neonates: A Randomised Controlled Trial (MOTIVE trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- General Movement Optimality Score- Revised (GMOS-R) at 34 weeks Post Menstrual Age (PMA)
研究概览
简要总结
The MOTIVE trial is a randomized controlled study comparing Movement Imitation Therapy (MIT) to standard care in very preterm and extreme preterm neonates. Conducted at Sri Ramachandra Institute of Higher Education and Research, the study aims to assess the impact of MIT on neurodevelopmental outcomes using the General Movement Optimality Score-Revised (GMOS-R) at 34 weeks post-menstrual age (PMA). The trial will involve stratified randomization of eligible preterm neonates, with MIT sessions incorporating guided limb movements mimicking normal general body movements. Secondary outcomes include GMOS-R at 5 months of corrected age, MRI/Neurosonogram findings at term-equivalent age, and the Hammersmith Neonatal Neurological Examination (HNNE) scores. The study follows ethical guidelines, ensuring informed parental consent and confidentiality, with blinded outcome assessment to minimize bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Day(s) 至 14.00 Day(s)(—)
- 性别
- All
入选标准
- •All pre-term neonates born between 26wks 0/7 to 31wks 6/7 weeks gestational age, admitted in Neonatal Intensive Care unit, and who are hemodynamically stable, from their second week of life.
排除标准
- •Neonates with genetic or congenital anomalies affecting motor function.
结局指标
主要结局
General Movement Optimality Score- Revised (GMOS-R) at 34 weeks Post Menstrual Age (PMA)
时间窗: At 34 weeks Post Menstrual Age (PMA)
次要结局
- 1. GMOS-R at 5 months of chronological age(2. Neurosonogram/MRI brain at term equivalent age)
研究者
Dr Meghana S
Sri Ramachandra Institute of Higher Education and Research
