| CTRI Number |
CTRI/2020/11/029390 [Registered on: 26/11/2020] Trial Registered Prospectively |
| Last Modified On: |
25/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
RETROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
A study of clinical profile of children with COVID 19 INFECTION admitted at tertiary care hospital |
|
Scientific Title of Study
|
A study of epidemiological and clinical features in children with COVID 19 INFECTION admitted at tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Sweety Patel |
| Designation |
Assistant Professor |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Department of Pediatrics
1 st floor, C1 block
SVP Hospital
Smt NHL Municipal Medical College, Ellis bridge , 380006
Ahmadabad
GUJARAT
380006
India |
| Phone |
9426360234 |
| Fax |
|
| Email |
drashishbhojak@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Sweety Patel |
| Designation |
Assistant Professor |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Department of Pediatrics
1 st floor, C1 block
SVP Hospital
Smt NHL Municipal Medical College
Ellis bridge, 380006
Ahmadabad
GUJARAT
380006
India |
| Phone |
9426360234 |
| Fax |
|
| Email |
drashishbhojak@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR Sweety Patel |
| Designation |
Assistant Professor |
| Affiliation |
Smt NHL Municipal Medical College |
| Address |
Department of Pediatrics
1st floor, C1 block
SVP Hospital
Smt NHL Municipal Medical College
Ellis bridge, 380006
Ahmadabad
GUJARAT
380006
India |
| Phone |
9426360234 |
| Fax |
|
| Email |
drashishbhojak@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Smt NHL Municipal Medical College
Ellis bridge, Ahmedabad
380006 |
|
|
Primary Sponsor
|
| Name |
Smt NHL Municipal Medical College |
| Address |
Smt NHL Municipal Medical College
Ellisbridge, Ahmedabad, Gujarat
380006 |
| 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 |
| DR Sweety Patel |
SVP Hospital , Ahmedabad |
Department of Pediatrics
1st floor, C1 block
SVP Hospital
Ahmadabad
GUJARAT |
9426360234
drashishbhojak@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NHL INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed cases of COVID 19 INFECTION (BY RTPCR OR RAPID ANTIGEN TESTING) admitted at tertiary care hospital |
|
| ExclusionCriteria |
| Details |
CHILDREN AGED LESS THAN 1 MONTH AND MORE THAN 12 YEARS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Epidemiological and clinical features |
28 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
28/11/2020 |
| 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="7"
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
|
AIMS AND OBJECTIVES: 1) TO STUDY EPIDEMIOLOGY AND CLINICAL MANIFESTATION 2) TO STUDY FAMILY PROFILE 3) TO ASSESS CLINICAL SEVERITY, COMORBIDITY AND COMPLICATION 4) TO OBSERVE OUTCOME |