| CTRI Number |
CTRI/2026/02/103831 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Accurately PIM-3 Score Predict Death in Children in the Intensive Care Unit |
|
Scientific Title of Study
|
Accuracy of the Paediatric Index of Mortality 3 Score in Predicting Mortality in the Paediatric Intensive Care Unit (PICU). |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gundewar Saurabh Vilas |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Pediatric, Jawaharlal Nehru Medical College, Sawangi Meghe ,Wardha
Wardha MAHARASHTRA 442004 India |
| Phone |
9028292612 |
| Fax |
|
| Email |
saurabhgundewar111@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Amar Taksande |
| Designation |
Professor and HOD |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Pediatric, Jawaharlal Nehru Medical College, Sawangi Meghe ,Wardha
Wardha MAHARASHTRA 442004 India |
| Phone |
9822369233 |
| Fax |
|
| Email |
AMAR.TAKSANDE@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Amar Taksande |
| Designation |
Professor and HOD |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Pediatric, Jawaharlal Nehru Medical College, Sawangi Meghe ,Wardha
Wardha MAHARASHTRA 442004 India |
| Phone |
9822369233 |
| Fax |
|
| Email |
AMAR.TAKSANDE@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawangi Meghe ,Wardha 442004 |
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
Sawangi Meghe , Wardha, Maharashtra, India, 442004 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Saurabh Gundewar |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH |
Department of Pediatric, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha Wardha MAHARASHTRA |
90282 92612
saurabhgundewar111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All critically ill children aged between 1month to 18 years of age admitted to PICU |
|
| ExclusionCriteria |
| Details |
Patients discharged or transferred within 24 hours of PICU admission |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Survived or died |
During ICU stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="293" Sample Size from India="293"
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)
|
23/02/2026 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Accurate prediction of mortality in the Pediatric Intensive Care Unit (PICU) is essential for risk stratification, clinical decision-making, benchmarking, and quality improvement. Several severity-of-illness scoring systems have been developed for this purpose, among which the Pediatric Index of Mortality (PIM) and Pediatric Risk of Mortality (PRISM) scores are the most widely used. The original PIM score, developed by Shann et al., was designed to estimate mortality risk based on physiological and diagnostic variables collected at the time of PICU admission. Subsequent revisions led to PIM2 and the currently used PIM3, which incorporates updated diagnostic categories and coefficients to improve predictive accuracy and calibration. PIM3 has been validated across multiple international PICU settings and has generally demonstrated good discriminatory ability, with reported area under the receiver operating characteristic curve (AUROC) values ranging from approximately 0.75 to 0.90. Its main advantage lies in its simplicity and early applicability, as it relies on data obtained within the first hour of PICU admission. This makes PIM3 particularly useful for early outcome prediction, audit, and inter-unit comparisons. However, studies have shown variability in calibration and predictive performance across different regions, especially in low- and middle-income countries, likely due to differences in case mix, disease severity, healthcare resources, and admission practices. In contrast, the PRISM III score, developed by Pollack et al., uses a more comprehensive set of physiological variables collected over the first 12–24 hours of PICU stay. While PRISM III is often considered highly accurate, its complexity and reliance on later data limit its utility for immediate risk assessment. Comparative studies between PIM3 and PRISM III have shown that both scores have comparable discrimination, though PRISM III may offer slightly better calibration in some settings, whereas PIM3 remains more practical for routine use. Given these variations, several authors have emphasized the importance of local and center-specific validation of mortality prediction models before their routine application. Such validation ensures that the scoring system accurately reflects local patient populations and care practices. In this context, evaluating the performance of PIM3 in a tertiary care PICU setting is justified to determine its accuracy, calibration, and applicability for mortality prediction, quality assurance, and benchmarking against established tools such as PRISM III. |