CTRI/2021/11/038180
Active, Not Recruiting
N/A
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) - EPR-PNP
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Health Condition 1: G00-G99- Diseases of the nervous system
- Sponsor
- AIIMS Rishikesh
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Children between ages 1 and 18 years
- •2\. Satisfying operational definition for neurocritical patient
- •3\. 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)
Exclusion Criteria
- •1\. Expected survival \<24 hours (PSOFA score \>20\)
- •2\. Children with absence of brain stem reflexes (PCPC score of 6\)
- •3\. Children requiring mechanical ventilation only during a perioperative period or for a period under the effect of sedatives/anesthetics for diagnostic procedures
- •4\. Catecholamine refractory shock for \>48 hours during initial 72 hours of mechanical ventilation
- •5\. Major surgery involving vital internal organs performed or being planned within 24 hours
- •6\. Active bleeding severe enough to be life threatening or cause hemodynamic instability
- •7\. Uncontrolled raised intracranial pressure
- •8\. Uncontrolled status epilepticus
- •9\. Rapidly progressive neurodegenerative disease
- •10\. Already received mechanical ventilation for \>72 hours
Outcomes
Primary Outcomes
Not specified
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