Health Condition 1: G00-G99- Diseases of the nervous system
Conditions
Interventions
Intervention1: Early protocolized rehabilitation: Physical therapy, occupational therapy and speech and language therapy for a duration for 12 weeks suited to the neurological disability, developmenta
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion 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
Exclusion criteria: 1. Expected survival 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare childrenâ??s functional outcome at 12 weeks as assessed by Pediatric Cerebral Performance Category (PCPC) between the EPR and usual care arm.Timepoint: 12 week | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Functional outcomes as measured by FSS and POPC scale. â?¢ Adaptive function as assessed by VABS â?¢ Gross motor function as measured by GMFM88 â?¢ Language problems as measured by LEST/CELF â?¢ Cognition as measured by MISIC/VSMS â?¢ Behavioural problems as measured by CBCL â?¢ Sleep problems assessed by CSHQ â?¢ Quality of life as assessed by PedsQL â?¢ Family functional outcomes as assessed by McMaster FAD â?¢ To compare the above mentioned parameters at 24 weeks of follow up â?¢ To see therapy failure rates (where untoward incident took place during therapy requiring termination of session) in the EPR arm â?¢ To assess prognostic markers predicting poor outcome in ventilated patients in both arms â?¢ To compare the number of patient-days and average number of days per patient during hospitalization, during which EPR and usual care was possible, as well as adverse effects and all cause mortality. Timepoint: 12 weeks and 24 weeks | — |
Countries
India
Contacts
Public ContactAman Elwadhi
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed