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CTRI Number  CTRI/2025/03/083358 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 24/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Neurological outcome in children with head injury 
Scientific Title of Study   Neuroprognostication in critically ill pediatric patients with moderate to severe traumatic brain injury: a prospective study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Indu kapoor 
Designation  Professor 
Affiliation  AIIMS NEW DELHI 
Address  Department of Neuroanaesthesiology and Neurocritical care

South West
DELHI
110029
India 
Phone  9013439134  
Fax    
Email  dr.indu.me@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Indu kapoor 
Designation  Professor 
Affiliation  AIIMS NEW DELHI 
Address  Department of Neuroanaesthesiology and Neurocritical care


DELHI
110029
India 
Phone  9013439134  
Fax    
Email  dr.indu.me@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Indu kapoor 
Designation  Professor 
Affiliation  AIIMS NEW DELHI 
Address  Department of Neuroanaesthesiology and Neurocritical Care


DELHI
110029
India 
Phone  9013439134  
Fax    
Email  dr.indu.me@gmail.com  
 
Source of Monetary or Material Support  
AIIMS NEW DELHI INDIA -110029 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  AIIMS NEW DELHI INDIA -110029 
Type of Sponsor  Research institution and hospital 
 
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 
INDU KAPOOR  AIIMS NEW DELHI  DEPARTMENT OF NEUROANAESTHESIOLOGY AND NEUROCRITICAL CARE AIIMS NEW DELHI INDIA -110029
South West
DELHI 
9013439134

dr.indu.me@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  pediatric trauma patients with moderate to severe traumatic head injury between 0–18 years of either gender admitted in neuro intensive care unit  
 
ExclusionCriteria 
Details  pediatric trauma patients with mild traumatic head injury between 0–18 years of either gender admitted in neuro intensive care unit  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the association of demographic variables, clinical variables, dependent variables and functional outcome   At 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/05/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Traumatic brain injury (TBI) is the leading cause of death and disability in critically ill pediatric patients, affecting up to 500,000 children per year in the United States. It is estimated that as many as 62% of these patients with moderate to severe TBI experience disability. Although TBI associated death rates have decreased over last few decades, disabilities for children who survive TBI continue to have significant impact on the society.  Current treatment guidelines for pediatric patients with TBI are largely adopted from guidelines for adult patients  and to improve the neurological outcome for pediatric TBI, there is an unmet need to understand factors affecting outcome after pediatric TBI. Neurocritical care society have recently published the guidelines for neuroprognostication in critically ill adult patients with moderate to severe TBI. By Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, they conducted a systematic narrative review of the ten clinically relevant predictors and nine prediction models cited in the literature. In clinical variables, only the presence of bilateral pupillary nonreactivity on admission was deemed moderately reliable predictor for functional outcomes at 6 months or beyond. In terms of prediction models, the Corticosteroid Randomization After Significant Head Injury (CRASH)-basic, CRASH-CT (CRASH-basic extended by computed tomography features), International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT)-core, IMPACT-extended, and IMPACT-lab models were recommended as moderately reliable in predicting mortality at discharge and beyond and functional outcomes at 6 months and beyond. The advances in prognosticating outcome after the injury in critically ill pediatric patients with TBI have been limited despite of extensive research in randomized controlled trials. Neuroprognosticating predictors for pediatric patients with moderate to severe TBI are still lacking. Although several studies demonstrated that various demographic or clinical variables (age, sex, GCS, GCS P, lactate, PT, APTT, INR) as well as other parameters (diffuse axonal injury, inclusion of MRI) which can influence the outcome in pediatric TBI patients, these factors have not been rigorously evaluated in the development of prognostic indicators. Analysis of existing trauma databases in critically ill pediatric patients may elucidate factors associated with worse outcomes after TBI and, in turn, provide discussion regarding neuroprognostication and anticipated resources needed after injury.


 
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