| CTRI Number |
CTRI/2024/08/072610 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
impact of Transfer and Transition protocol on incidence of physiological complications and adverse events during transfer of pediatric patients |
|
Scientific Title of Study
|
An operational study to assess the impact of Transfer and Transition Protocol on incidence of physiological complications and adverse events among patients admitted in Pediatric Emergency, Advanced Pediatric Centre, PGIMER, Chandigarh, 2023-25 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narendra kumar |
| Designation |
Nursing student |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
National institute of nursing education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9785685509 |
| Fax |
- |
| Email |
saroyanicks25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Dutta |
| Designation |
associate professor |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
National institute of nursing education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
- |
| Email |
monika.dutta75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Narendra kumar |
| Designation |
Nursing |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
National institute of nursing education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9785685509 |
| Fax |
- |
| Email |
saroyanicks25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Narendra kumar |
| Address |
National institute of nursing education, PGIMER, Chandigarh-160012 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Narendra kumar |
Post graduate institute medical science and research , Chandigarh |
Advance pediatric centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9785685509
saroyanicks25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z759||Unspecified problem related to medical facilities and other health care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Transfer and Transition Protocol |
to develop a checklist for safe transfer and transition of critically ill children that may prevent physiological complications and adverse events. intervention would be done for 2 months |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
transfer of critically ill children |
|
| ExclusionCriteria |
| Details |
no exclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce incidence of physiological complications and adverse events during transfer and transition i.e. 8 weeks |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| current practices following by health care team for transfer of patients form 4 weeks |
current practices following by health care team for transfer of patients 4 weesk |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/08/2024 |
| 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="6"
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
|
This is an operational study to assess the Impact of "Transfer and Transition protocol" on physiological complications and adverse events occuring during transfer and transition of critically ill children in PGIMER, Chandigarh. This study will help in smooth and safe intrahospital transfer of critically ill children. It will take place in four phases. |