| CTRI Number |
CTRI/2021/04/032819 [Registered on: 15/04/2021] Trial Registered Prospectively |
| Last Modified On: |
14/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Patterns And Severity Of Falling Platelet Counts In Children With Dengue Fever |
|
Scientific Title of Study
|
Patterns and Severity Of Thrombocytopenia In Dengue Fever In Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 923/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharath Krishna Sathyan |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Paediatrics Department, Kasturba Medical College and Hospital (MAHE) Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India |
| Phone |
9539064091 |
| Fax |
|
| Email |
sharathkrishna57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Bhat Y |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Paediatrics Department, Kasturba Medical College and Hospital (MAHE) Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India |
| Phone |
9686401313 |
| Fax |
|
| Email |
docrameshbhat@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandesh Kini B |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Paediatrics Department, Kasturba Medical College and Hospital (MAHE) Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India |
| Phone |
9731149519 |
| Fax |
|
| Email |
sandesh.kini@manipal.edu |
|
|
Source of Monetary or Material Support
|
| KMC Hospital, MAHE, Manipal, Udupi, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Sharath Krishna Sathyan |
| Address |
Junior Resident, Department of Paediatrics
Kasturba Medical College and Hospital
Kasturba Medical College and Hospital MAHE MAHE Udupi KARNATAKA 576104 India
|
| Type of Sponsor |
Other [] |
|
|
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 Sharath Krishna Sathyan |
Kasturba Medical College and Hospital |
Paediatrics Department
MAHE
Udupi Karnataka 576104 India
Udupi
KARNATAKA |
9539064091
sharathkrishna57@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A90||Dengue fever [classical dengue], |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 1 month to 18 years, admitted in the Department of Paediatrics, Kasturba Hospital with features of suspected or probable dengue with positive Dengue IgM test or NS1 Ag test.
•Children tested positive for Dengue fever before hospitalisation will also be included in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with known cases of thrombocytopenia like ITP or associated syndromes.
2.Children tested positive for other infections like Malaria, Leptospirosis, scrub typhus, typhoid.
3.Children whose parents refuse to participate in the study
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
•To study the platelet counts in children diagnosed with dengue fever in relation to onset of illness.
•To correlate the platelet counts in children diagnosed with dengue fever with severity of illness (D-W , D+W and SDF).
|
At the time of admission
Through the Hospital stay
At the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To obtain a clinical profile of dengue illness in children in relation to their severity |
At the time of admission |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/04/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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, clinical: single
centre, observational study to study the relation between platelet counts and
severity of illness in children with Dengue Fever. This study will be conducted in a single centre in India- Department of Paediatrics,
Kasturba Medical College and Hospital, MAHE, Manipal, Karnataka,
India.The primary outcome is to To study the platelet counts in children diagnosed with dengue fever in
relation to onset of illness and correlate the platelet counts in children diagnosed with dengue fever
with severity of illness (D-W , D+W and SDF). |