| 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
|
|
|
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
|
|
|
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.
|