Development, Validation and Feasibility testing of Multimodal Early Stimulation Program for Preterm Infants in Neonatal Intensive Care Unit
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Feasibility of Multimodal Early Stimulation Program (Adherence rate, acceptance rate, attrition rate, clinical fidelity, ease of performance, deviations from the protocol and adverse events)
研究概览
简要总结
This study will commence recruiting preterm infants once a panel of experts validates the developed protocol to ensure it is safe to be implemented on the babies. This study will evaluate the feasibility of applying a gestational week-specific comprehensive early stimulation protocol in real-world settings, especially in low and middle-income countries. The findings of this study will help in designing future randomised control trials ensuring quality care
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 90.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm infants born between the gestational age of 26 weeks and 35 weeks APGAR score greater than 7 at birth Haemodynamically stable preterm infants.
排除标准
- •Congenital anomalies Invasive ventilation Parents not willing to participate in the study Retinopathy of prematurity Bone fracture Intraventricular haemorrhage.
结局指标
主要结局
Feasibility of Multimodal Early Stimulation Program (Adherence rate, acceptance rate, attrition rate, clinical fidelity, ease of performance, deviations from the protocol and adverse events)
时间窗: Every 7th day. From enrollment to discharge | Baseline and endline will be taken
次要结局
- Content Validity of the developed protocol (Multimodal Early Stimulation Program)(2 weeks)
研究者
Abishek J R
SRM College of Physiotherapy, SRM Institute of Science and Technology