Health Condition 1: Q209- Congenital malformation of cardiacchambers and connections, unspecified
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 groupTimepoint: 4-6 weeks after receiving 3rd dose of DPT containing vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 groupTimepoint: 4-6 weeks after receiving 3rd dose of DPT containing vaccine | — |
Countries
India
Contacts
UCMS and GTBH