Multimodal Early Stimulation for Preterm Infants Admitted in Neonatal Intensive Care Unit: A Pilot Feasibility Non-Randomized Trial In Tamil Nadu Context
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary Feasibility Outcomes:
研究概览
简要总结
This study will evaluate the feasibility of applying a gestational week-specific comprehensive early stimulation protocol in settings, especially in low and middle-income countries with motherr a the primary care provider and it will also evaluate the efficacy of the developed protocol in improving neurodevelopmental outcomes.
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
Primary Feasibility Outcomes:
时间窗: The test for feasibility will be assessed at the time of admission, every week after that, till the point of discharge. | Retention rates will be assessed at the time of discharge | Recruitment rate will be assessed at the time of admission
• Recruitment and retention rates:
时间窗: The test for feasibility will be assessed at the time of admission, every week after that, till the point of discharge. | Retention rates will be assessed at the time of discharge | Recruitment rate will be assessed at the time of admission
• Descriptive statistics, which include percentages, means, and medians will be applied to summarize recruitment rates, participant retention, and attrition.
时间窗: The test for feasibility will be assessed at the time of admission, every week after that, till the point of discharge. | Retention rates will be assessed at the time of discharge | Recruitment rate will be assessed at the time of admission
• Therapy fidelity:
时间窗: The test for feasibility will be assessed at the time of admission, every week after that, till the point of discharge. | Retention rates will be assessed at the time of discharge | Recruitment rate will be assessed at the time of admission
Calculate adherence rates to the intervention protocol and assess deviations using proportions and confidence intervals.
时间窗: The test for feasibility will be assessed at the time of admission, every week after that, till the point of discharge. | Retention rates will be assessed at the time of discharge | Recruitment rate will be assessed at the time of admission
次要结局
- Neurodevelopmental Outcomes:(Analyze Premie-Neuro Scale scores for pre- and post-intervention data.)
研究者
Dr Vadivelan Kanniappan
SRM College of Physiotherapy, SRM Institute of Science and Technology