| CTRI Number |
CTRI/2025/08/093863 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The effect of the mode of transport on the condition of the child on arrival in the pediatric emergency. |
|
Scientific Title of Study
|
Mode of transport of referred vs non referred critically ill children and its correlation with patient clinical status at presentation in the pediatric emergency department- A prospective observational cohort study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Medapati Kartik |
| Designation |
MD Student |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
MS Office,
Department of Hospital Administration,
Nehru Hospital, Ground Floor,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9538497270 |
| Fax |
|
| Email |
kartik.medapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar Tadia |
| Designation |
Associate Professor and Guide |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no. 2103,
Advanced Pediatrics Centre,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9871097100 |
| Fax |
|
| Email |
vijaytadia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kumar Tadia |
| Designation |
Associate Professor and Guide |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no. 2103,
Advanced Pediatrics Centre,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9871097100 |
| Fax |
|
| Email |
vijaytadia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Dr. Vijay Kumar Tadia |
| Address |
Room no. 2103,
Advanced Pediatrics Centre,
PGIMER, Chandigarh- 160012 |
| Type of Sponsor |
Other [Chief Guide] |
|
|
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 Medapati Kartik |
Post Graduate Institute of Medical Education and Research |
MS Office, Ground Floor,
Department of Hospital Administration,
Nehru Hospital, PGIMER,
Chandigarh
Chandigarh
CHANDIGARH |
9538497270
kartik.medapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged less than 13 years who report to the Pediatric emergency area of the Advanced Pediatric Centre. |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to participate.
2. Brought dead patients.
3. Unknown patients with no identifiable records.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical status at presentation (as measured by triage system proforma) with mode of transport in referred vs non-referred patients in the Pediatric emergency. |
At enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in clinical state as per triage level at presentation in pediatric emergency based on ambulance vs non-ambulance transport |
At enrollment |
| To determine the Socioeconomic status of patients using Modified Kuppuswamy Scale and measure how it correlates with clinical state as per triage level at presentation in pediatric emergency. |
At enrollment |
| To determine the relationship between distance traveled and how it correlates with clinical state as per triage level at presentation in pediatric emergency. |
At enrollment |
| To determine the delay in presentation to emergency and reasons for such delays in presentation to the Emergency after Referral (measured in hours and days) |
At enrollment |
|
|
Target Sample Size
|
Total Sample Size="358"
Sample Size from India="358"
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)
|
08/09/2025 |
| 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="0"
Months="10"
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
study is a prospective observational cohort study comparing the mode of
transport used by referred and non-referred patients and its correlation to the
clinical status at presentation in the pediatric emergency which will be
conducted in the Advanced Paediatrics Center, PGIMER. A total of 358
participants will be recruited for the study. The primary objective is to compare the clinical status at
presentation (as measured by triage system proforma) with mode of transport in
referred vs non-referred patients in the Pediatric emergency. Secondary
objectives include
1.
Measuring
difference in clinical state as per triage level at presentation in pediatric
emergency based on ambulance vs non-ambulance transport,
2.
To
determine the Socio-economic status of patients using modified Kuppuswamy scale
and measure how it correlates with clinical state as per triage level at
presentation in pediatric emergency.
3.
To
determine the relationship between distance travelled and how it correlates
with clinical state as per triage level at presentation in pediatric emergency.
4.
To
determine the delay in presentation to emergency and reasons for such delays in
presentation to the Emergency after Referral (measured in hours/days)
|