| CTRI Number |
CTRI/2025/08/093878 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating how well triage tools help doctors decide which children need immediate care and which can wait in the emergency department |
|
Scientific Title of Study
|
Predictability of triaging tools for triaging and reverse triaging in pediatric emergency setting |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 13A Department of pediatrics Maulana Azad Medical College 2 Bahadurshah Zafar marg New Delhi
Central
DELHI
-2
India |
| Phone |
7827134925 |
| Fax |
|
| Email |
mansimahour@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Romit Saxena |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics Maulana Azad Medical College 2 Bahadurshah Zafar Marg New Delhi
Central
DELHI
110002
India |
| Phone |
9597650364 |
| Fax |
|
| Email |
drromit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Romit Saxena |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics Maulana Azad Medical College 2 Bahadurshah Zafar Marg New Delhi
Central
DELHI
110002
India |
| Phone |
9597650364 |
| Fax |
|
| Email |
drromit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college 2,Bahadurshah Zafar Marg New Delhi
Delhi 110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Maulana Azad Medical College 2 Bahadurshah Zafar marg New Delhi
Delhi 110002 |
| Type of Sponsor |
Government 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 Mansi |
Lok Nayak Hospital |
Ward 14 Pediatric Emergency Maulana Azad Medical College and Associated Lok Nayak Hospital
Central
DELHI |
7827134925
mansimahour@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals Lok Nayak, GB Pant Institute Post Graduate Medical Education (GIPMER) and Research Hospital, Guru nayak Eye Centre New Delhi 110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z758||Other problems related to medicalfacilities and other health care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Child of age 1 month to 12 years Presenting to pediatric emergency department of Lok Nayak Hospital after due consent |
|
| ExclusionCriteria |
| Details |
Referrals from other departments, Leave against medical adive with pediatric emergency, Brought dead to emergency department |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Specificity, sensitivity, PPV and NPV of ESI version 5, IMNCI , IAP ALS and PREM for
Prediction of Mortality at 48 hours. |
Specificity, sensitivity, PPV and NPV of ESI version 5, IMNCI , IAP ALS and PREM for
Prediction of Mortality at 48 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Specificity, sensitivity, PPV and NPV of PREM, ESI version 5, IMNCI and IAP ALS for
Prediction of Recovery at 2 days and 4 days
2. Resource utilization for reverse triaged patients as per triaging tool- In each of the
subcategorizations of the triaging tools we shall determine the percentage of occurrence of
Acute kidney injury, percentage of children requiring oxygen in each , Requirement and
Duration of Oxygen Requirement, Mode of Oxygen Required, Duration of Stay,
Requirement and Duration of Ventilation, Percentage of children requiring antibiotics and
duration , Percentage of children requiring inotrope/Vasopressor and their max VIS Score,
percentage of children requiring fluid Resuscitation, percentage of children requiring blood
Products |
2nd day and 4th day |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
23/09/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included Mansimahour@gmail.com).
- For how long will this data be available start date provided 24-09-2025 and end date provided 26-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This observational longitudinal study at the Pediatric Emergency Department of Maulana Azad Medical College aims to compare four triaging tools—IMNCI, PREM, ESI v5, and IAP ALS—in predicting 48-hour mortality, recovery at 2 and 4 days, and resource utilization. Children aged 1 month to 12 years presenting to the emergency department will be triaged at baseline and exit. Reverse triaging will also be assessed for surge capacity planning. Sensitivity, specificity, Positive predictive value and Negative predictive value will be calculated for each tool. The study addresses the paucity of Indian data on head-to-head triage tool comparisons for mortality prediction and emergency resource optimization. |