| CTRI Number |
CTRI/2026/01/101175 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Identifying crtically ill children early:A study of warning scores in breathing Difficulty |
|
Scientific Title of Study
|
A Study on Comparison Between Paediatric Advanced Warning Score And Paediatric Early Warning Score In Predicting Intensive Care Unit Amissions In Infants And Children With Respiratory Distress |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
E Gokula Krishnan |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka Missions Kirupananada Variyar Medical College And Hospital |
| Address |
no:1/131,kannadasan 4th street,NH-3,maraimalainagar
Kancheepuram
TAMIL NADU
603209
India |
| Phone |
9094601288 |
| Fax |
|
| Email |
drgokulelango7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K V Pugalenendhi Raja |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananada Variyar Medical College And Hospital |
| Address |
Dept of paediatrics,Vinayakaga missions kirupannada variyar medical college and hospitals,salem
Salem
TAMIL NADU
636308
India |
| Phone |
9443410893 |
| Fax |
|
| Email |
drkvpraja@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
E Gokula Krishnan |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka Missions Kirupananada Variyar Medical College And Hospital |
| Address |
Vinayakaga missions kirupananda variyar medical college and hospital
Salem
TAMIL NADU
636308
India |
| Phone |
9094601288 |
| Fax |
|
| Email |
drgokulelango7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
E Gokula Krishnan |
| Address |
Vinayakaga missions kirupananda variyar medical college and hospitals,salem,636308 |
| 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 |
| E Gokula Krishnan |
vinayakaga missions kirupananda variyar medical college and hospitals |
department of paediatrics
Salem
TAMIL NADU |
9094601288
drgokulelango7@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: J069||Acute upper respiratory infection,unspecified, |
|
|
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 |
Presenting with clinical signs of respiratory distress(e.g:tachypnea,chest retractions,nasal flaring,grunting,use of accessory muscle) |
|
| ExclusionCriteria |
| Details |
Children with pre-existing chronic respiratory conditions(e.g: cystic fibrosis,BPD)
known CHD or NMD affecting respiration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Picu amissions |
1.5 years |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
30/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective observational study compares the effectiveness of the Paediatric Advanced Warning Score (PAWS) and the Paediatric Early Warning Score (PEWS) in predicting Paediatric Intensive Care Unit (PICU) admissions among infants and children presenting with respiratory distress. Conducted over a 1.5Year period (2025–2027) at the Emergency Department and PICU of VMKVMCH, Salem, the study includes 250 children aged 1 month to 12 years.
Both PAWS and PEWS are applied within 15 minutes of presentation using structured clinical parameters. The primary outcome is PICU admission, and the predictive performance of both scores is evaluated using sensitivity, specificity, positive and negative predictive values, and ROC curve analysis. Statistical analysis will be performed using SPSS software.
The study aims to determine whether PAWS, which incorporates additional physiological parameters such as oxygen saturation, temperature, and AVPU scale, offers superior predictive accuracy compared to PEWS. The findings are expected to guide clinicians in early identification of critically ill children with respiratory distress and support the adoption of a more effective early warning system in pediatric emergency care |