| CTRI Number |
CTRI/2021/03/032078 [Registered on: 17/03/2021] Trial Registered Prospectively |
| Last Modified On: |
16/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the type of viruses causing fever and cold among Children under 5 years of age |
|
Scientific Title of Study
|
Virological profile of Upper Respiratory Infections Among Children under 5 years of age |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navankur Chakma |
| Designation |
Post Graduate Resident |
| Affiliation |
Department of Paediatrics Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
9650537108 |
| Fax |
|
| Email |
navankur12@rediff.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Agarwal |
| Designation |
Associate Professor |
| Affiliation |
Department of Paediatrics Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
9810409625 |
| Fax |
|
| Email |
doctoranuragagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Navankur Chakma |
| Designation |
Post Graduate Resident |
| Affiliation |
Department of Paediatrics, Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
9650537108 |
| Fax |
|
| Email |
navankur12@rediff.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Department of Paediatrics |
| Address |
Maulana Azad Medical College, New Delhi |
| 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 |
| Navankur Chakma |
Lok Nayak Hospital |
Room no 516 Paediatrics OPD Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
DELHI |
9650537108
navankur12@rediff.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: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children less than 5 years of age presenting with fever > 100 F and coryza
Duration of symptoms less than or equal to 7 days |
|
| ExclusionCriteria |
| Details |
Known case of immunodeficiency states, orofacial or nasal malformations
Respiratory distress
Known history of epistaxis
Known case of bleeding diathesis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Virological profile of upper respiratory infections in children under 5 years of age |
On day of OPD visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Seasonal variation of viruses causing upper respiratory infections in children under 5 years of age |
On the day of OPD visit |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
20/03/2021 |
| 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="0"
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 an observational study to find out the virological profile of upper respiratory tract infections in children under 5 years of age in 180 patients that will be conducted in the department of paediatrics in Maulana Azad medical college, New Delhi. The primary outcome will be to find out the virological profile of upper respiratory infections in children under 5 years of age. The secondary outcome will be the seasonal variation of viruses causing upper respiratory infections in children under 5 years of age |