| CTRI Number |
CTRI/2024/05/066592 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the protective titre of DPT vaccine in children with Congenital Heart Disease |
|
Scientific Title of Study
|
Sero protection of DPT containing vaccine in congenital heart disease: A cross sectional 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 ARSHAD |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Room No 601, Pediatrics department 6th floor MCH Building UCMS AND GTB HOSPITAL
North East
DELHI
110095
India |
| Phone |
9576977063 |
| Fax |
|
| Email |
632arshadhussain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumaira Khalil |
| Designation |
Associate Professor |
| Affiliation |
UCMS and GTBH |
| Address |
Room No 601, 6th Floor, MCH Buidling, Department of Pediatrics, UCMS and GTB Hospital Delhi
Shahdara, Dilashad Garden, Delhi
North East
DELHI
110095
India |
| Phone |
9810424664 |
| Fax |
|
| Email |
skhalil@ucms.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumaira Khalil |
| Designation |
Associate Professor |
| Affiliation |
UCMS and GTBH |
| Address |
Room No 601, 6th Floor, MCH Buidling, Department of Pediatrics, UCMS and GTB Hospital Delhi
Shahdara, Dilashad Garden, Delhi
North East
DELHI
110095
India |
| Phone |
9810424664 |
| Fax |
|
| Email |
skhalil@ucms.ac.in |
|
|
Source of Monetary or Material Support
|
| intramural Research Grant, University College of Medical Sciences Delhi India 110095 |
|
|
Primary Sponsor
|
| Name |
Intramural Research Grant University College of Medical Sciences |
| Address |
UCMS Dilshad garden Delhi India 110095 |
| 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 |
| Dr Sumaira Khalil |
University college of medical sciences and GTB hospital |
Department of Pediatrics, 6th Floor, MCH Building, UCMS and GTB Hospital, Dilshad Garden, Delhi India 110095
North East
DELHI |
9810424664
skhalil@ucms.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-Human Research (IEC-HR) UNIVERSITY OF MEDICAL SCIENCES UNIVERSITY OF DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q209||Congenital malformation of cardiacchambers and connections, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
All consecutive children visiting the pediatric outpatient department and
admitted patients from the Pediatrics ward will be assessed for eligibility criteria.
i. Cases: Children (16-24 months) with echocardiographic confirmed congenital heart
disease attending pediatric OPD or IPD and previously received 3 primary doses and
at least 1 booster dose of DPT-containing vaccine.
ii. Comparison group: Healthy Children (16-24 months) without congenital heart disease
attending pediatric OPD or IPD and previously received 3 primary doses and at least 1
booster dose of DPT-containing vaccine. |
|
| ExclusionCriteria |
| Details |
1 Children receiving prolonged steroid therapy more than 4 weeks in the past 3 months
2 History of administration of blood or immunoglobulin in the last 3 months
3 Known case of malignancy or primary immunodeficiency or infant of HIV positive
mother
4 Children suffering from other chronic diseases example chronic liver disease or chronic
renal disease or thalassemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary: To compare the proportion of children having seroprotective
antibody titers against diphtheria between cases and comparison group.
Secondary: (i) To compare the proportion of children having seroprotective antibody titers
against pertussis between cases and comparison group. (ii) To compare the proportion of
children having seroprotective antibody titers against tetanus between cases and comparison
group (iii) To compare antibody titers against Diphtheria, Pertussis and Tetanus between
cases and comparison group |
4-6 weeks after receiving 3rd dose of DPT containing vaccine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(i) To compare the proportion of children having seroprotective antibody titers
against pertussis between cases and comparison group. (ii) To compare the proportion of
children having seroprotective antibody titers against tetanus between cases and comparison
group
(iii) To compare antibody titers against Diphtheria, Pertussis and Tetanus between
cases and comparison group |
4-6 weeks after receiving 3rd dose of DPT containing vaccine |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
15/05/2024 |
| 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="1"
Months="5"
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
|
Title: Seroprotection of Diphtheria, Pertussis and Tetanus (DPT) containing vaccine in children with Congenital Heart Disease: A Cross-Sectional study Aim: To determine the seroprotection of DPT-containing vaccine administered as per the National Immunisation Schedule in children with Congenital Heart Disease Primary Objective: To compare the proportion of children with Congenital Heart Disease and those without congenital heart disease having seroprotective antibody titers against Diphtheria, 4-6 weeks after receiving 1st booster of DPT vaccine at 16-24 months. Secondary Objective i. To compare the proportion of children with and without congenital heart disease having seroprotective antibody titers against Pertussis, 4-6 weeks after receiving 1st booster of DPT at 16-24 months ii. To compare the proportion of children with and without congenital heart disease having seroprotective antibody titers against Tetanus, 4-6 weeks after receiving 1st booster of DPT vaccine at 16-24 months iii. To compare antibody titers against diphtheria, pertussis and tetanus in children with and without congenital heart disease 4-6 weeks after receiving 1st booster dose of the DPT vaccine at 16-24 months. Setting: Department of Pediatrics & Microbiology, University College of Medical Sciences & GTB Hospital, Delhi Study Period: April 2024-August 2025 Ethics: Ethical clearance will be obtained from the Institutional Ethics Committee for Human Research, UCMS Consent: Informed written consent will be taken from parents or guardians of all participants Participants All consecutive children visiting the pediatric outpatient department and admitted patients from the Pediatrics ward will be assessed for eligibility criteria. i. Cases: Children (16-24 months) with echocardiographic confirmed congenital heart disease attending pediatric OPD or IPD and previously received 3 primary doses and at least 1 booster dose of DPT-containing vaccine. ii. Comparison group: Healthy Children (16-24 months) without congenital heart disease attending pediatric OPD or IPD and previously received 3 primary doses and at least 1 booster dose of DPT-containing vaccine. Exclusion criteria (both for cases and controls) i. Children receiving prolonged steroid therapy (>4 weeks) in the past 3 months ii. History of administration of blood or immunoglobulin in the last 3 months iii. Known case of malignancy or primary immunodeficiency or infant of HIV-positive Mother iv. Children suffering from other chronic diseases (e.g. chronic liver disease, chronic renal disease, thalassemia) Sample Size: 35 children (16-24 months) with echocardiographic confirmed congenital heart disease and 35 healthy children (16-24 months) who have received three primary doses and at least one booster dose of DPT-containing vaccine. Outcome Measure: Primary: To compare the proportion of children having seroprotective antibody titers against diphtheria between cases and comparison group. Secondary: (i) To compare the proportion of children having seroprotective antibody titers against pertussis between cases and comparison group. (ii) To compare the proportion of children having seroprotective antibody titers against tetanus between cases and comparison group (iii) To compare antibody titers against Diphtheria, Pertussis and Tetanus between cases and comparison group. |