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CTRI Number  CTRI/2021/11/038180 [Registered on: 22/11/2021] Trial Registered Prospectively
Last Modified On: 30/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing an Early Protocolized Rehabilitation versus usual care in improving functional outcomes in Pediatric Neurocritical Patients of age 1-18 years 
Scientific Title of Study   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) 
Trial Acronym  EPR-PNP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aman Elwadhi 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Pediatrics Level 6 AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9810943681  
Fax    
Email  elwadhiaman@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Indar Kumar Sharawat 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Pediatrics Level 6 AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9560182301  
Fax    
Email  sherawatdrindar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aman Elwadhi 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Pediatrics Level 6 AIIMS Rishikesh Uttarakhand


UTTARANCHAL
249203
India 
Phone  9810943681  
Fax    
Email  elwadhiaman@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  Department of Pediatrics AIIMS Rishikesh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aman Elwadhi  AIIMS Rishikesh  Department of Pediatrics Level 6 AIIMS Rishikesh Uttarakhand
Dehradun
UTTARANCHAL 		 9810943681

elwadhiaman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Early protocolized rehabilitation  Physical therapy, occupational therapy and speech and language therapy for a duration for 12 weeks suited to the neurological disability, developmental status and type of illness at the time of enrolment 
Comparator Agent  Usual care  The usual care provided to pediatric neurocritical care patients for 12 weeks 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  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) 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare children’s functional outcome at 12 weeks as assessed by Pediatric Cerebral Performance Category (PCPC) between the EPR and usual care arm.  12 week 
 
Secondary Outcome  
Outcome  TimePoints 
• Functional outcomes as measured by FSS and POPC scale.
• Adaptive function as assessed by VABS
• Gross motor function as measured by GMFM88
• Language problems as measured by LEST/CELF
• Cognition as measured by MISIC/VSMS
• Behavioural problems as measured by CBCL
• Sleep problems assessed by CSHQ
• Quality of life as assessed by PedsQL
• Family functional outcomes as assessed by McMaster FAD
• To compare the above mentioned parameters at 24 weeks of follow up
• To see therapy failure rates (where untoward incident took place during therapy requiring termination of session) in the EPR arm
• To assess prognostic markers predicting poor outcome in ventilated patients in both arms
• 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.
 		 12 weeks and 24 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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