Effect of Multimodal Integrated Rehabilitation using TAKO Protocol on Oro-motor and Respiratory Complications in Infants with Pneumonia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- ABG Analysis
研究概览
简要总结
The primary aim of the study is to investigate the impact of the TAKO protocol, a multimodal rehabilitation approach, on oro-motor and respiratory complications in infants with pneumonia. The study is crucial as it address a significant gap in the understanding of rehabilitation strategies for onfants with pneumonia, particularly focusing on oromotor and respiratory complications. Infants are vulnerable to these complications and the TAKO protocol represents a novel approach that integrates multiple rehabilitation modalities. By conducting a randomized control trial, the research aims to provide robust evidence on the effectiveness of this protocol, contributing valuable insights to infants care practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 6.00 Month(s)（—）
- 性别
- All
入选标准
- •Infants aged between 1 day to 6 months
- •Clinical diagnosis of pneumonia based on established criteria.
- •Infants admitted to the neonatal intensive care unit (NICU) or Paediatric Intensive Care Unit (PICU) or Paediatric ward
- •Written informed consent obtained from parents or legal guardians.
排除标准
- •Gestational age less than 37 weeks
- •Major congenital anomalies affecting oromotor or respiratory function.
- •Severe neurological impairment or congenital disorders affecting swallowing or breathing
- •Participation in concurrent interventions targeting oromotor or respiratory function.
结局指标
主要结局
ABG Analysis
时间窗: Baseline, 2nd week and 4th week
Oromotor Assessment Scale (OMAS)
时间窗: Baseline, 2nd week and 4th week
次要结局
- Infant Neurological International Battery (INFANIB)(Baseline, 2nd week and 4th week)
研究者
Sakshi Desai
Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research(DU),Wardha