CTRI/2021/11/038180进行中（未招募）不适用
Comparison of an Early Protocolized Rehabilitation (EPR) versus usual care in improving functional outcomes at 12 weeks in Pediatric Neurocritical Patients (PNP) of age 1-18 years: A Randomized Controlled Trial (EPR-PNP trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare children’s functional outcome at 12 weeks as assessed by Pediatric Cerebral Performance Category (PCPC) between the EPR and usual care arm.
研究概览
简要总结
This is a randomized controlled trial to see the advantages of an early protocolized rehabilitation program over usual care to improve functional outcomes (motor, cognitive, adaptive, behavioural, sleep, language, functional status and quality of life) in pediatric neurocritical care patients in a pediatric intensive care unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between ages 1 and 18 years
- •Satisfying operational definition for neurocritical patient
- •Premorbid Pediatric Cerebral Performance Category (PCPC) score of 1 or 2 within 2 weeks of onset of illness Pediatric Neurocritical Patients (PNP) for the purpose of the study will be defined as: I.
- •Suffering from primary neurological illness with PCPC score of 3-5 at enrollment (or) II.
- •Suffering from any other systemic illness on invasive or non-invasive mechanical ventilation with a.
- •Evidence of metabolic, septic or hypertensive encephalopathy not completely reversible within 72 hours b.
- •Coexisting predisposing factors towards hypoxic-ischemic encephalopathy (OI>15, OSI>7.5, requiring any CPR).
排除标准
- •Expected survival <24 hours (PSOFA score >20)
- •Children with absence of brain stem reflexes (PCPC score of 6)
- •Children requiring mechanical ventilation only during a perioperative period or for a period under the effect of sedatives/anesthetics for diagnostic procedures
- •Catecholamine refractory shock for >48 hours during initial 72 hours of mechanical ventilation
- •Major surgery involving vital internal organs performed or being planned within 24 hours
- •Active bleeding severe enough to be life threatening or cause hemodynamic instability
- •Uncontrolled status epilepticus
- •Rapidly progressive neurodegenerative disease
- •Already received mechanical ventilation for >72 hours.
结局指标
主要结局
To compare children’s functional outcome at 12 weeks as assessed by Pediatric Cerebral Performance Category (PCPC) between the EPR and usual care arm.
时间窗: 12 week
次要结局
- • Functional outcomes as measured by FSS and POPC scale.(• Adaptive function as assessed by VABS)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Very Early Rehabilitation in Acute Ischemic StrokeStrokeNCT01694992Hospital de Clinicas de Porto Alegre184
Unknown
不适用
Comparison of Rehabilitation Intervention, Supported by Telemedicine, With Standard Rehabilitation After Distal Radius Fracture.Distal Radius FractureNCT05463653Hospital Clinico Mutual de Seguridad50
已完成
不适用
Early Rehab With VR for First-time Acute StrokeStroke, AcuteAcute Ischemic StrokeNCT05929742National Defense Medical Center, Taiwan38
进行中（未招募）
不适用
Comparing an Early Protocolized Rehabilitation versus usual care in improving functional outcomes in Pediatric Neurocritical Patients of age 1-18 yearsCTRI/2021/11/038180AIIMS Rishikesh
招募中
不适用
Controlled Active Motion vs Early Passive Mobilization for Flexor Tendons RepairFlexor Tendon RuptureNCT06420648University of Hail50