| CTRI Number |
CTRI/2025/12/099133 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the reasons for delay in diagnosis of congenital heart disease |
|
Scientific Title of Study
|
Delays in pathways to care in children with congenital heart disease presenting to a tertiary care hospital in Delhi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kinshuk Gupta |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 360, Department of Community Medicine, Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, Near Delhi Gate, Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9560871782 |
| Fax |
|
| Email |
kinshuksameer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mongjam Meghachandra Singh |
| Designation |
Head of Department and Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
HoD office, Department of Community Medicine Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi Gate, Delhi-110002
Central
DELHI
110002
India |
| Phone |
919818354458 |
| Fax |
|
| Email |
megharita1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mongjam Meghachandra Singh |
| Designation |
Head of Department and Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
HoD office, Department of Community Medicine Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi Gate, Delhi-110002
Central
DELHI
110002
India |
| Phone |
919818354458 |
| Fax |
|
| Email |
megharita1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Medicine Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, Near Delhi Gate, Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, Near Delhi Gate, Delhi - 110002 |
| 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 Kinshuk Gupta |
Maulana Azad Medical College |
Room No 360, Department of Community Medicine, Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, Near Delhi Gate, Delhi - 110002
Central
DELHI |
9560871782
kinshuksameer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College Institutional Ethics Committee |
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 |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children from age 1 months to 12 years suffering from congenital heart disease presenting to a tertiary care hospital |
|
| ExclusionCriteria |
| Details |
Children admitted in ICU |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome:
Proportion of children with delayed diagnosis of congenital heart disease
|
At the end of data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Median & interquartile range of duration of ‘patient interval’ in days.
|
At the end of data collection |
Median & interquartile range of duration of ‘diagnostic interval’ in days.
|
At the end of data collection |
Pattern of health seeking behaviour & other associated factors with the delay summarized as proportions.
|
At the end of data collection |
|
|
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)
|
30/12/2025 |
| 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 Yet Recruiting |
| 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
|
This study aims to assess delays in the diagnosis of congenital heart disease in children presenting to a tertiary care hospital in Delhi. Congenital heart disease is one of the most common birth defects and early diagnosis is critical for reducing morbidity and mortality. In low and middle income settings, delays in diagnosis are common and often linked to late recognition of symptoms, gaps in screening, limited access to specialist care, and barriers within the health system. Understanding these delays is important for designing effective interventions and improving timely access to treatment.
This is a facility based cross sectional study conducted in the Pediatrics Department of Lok Nayak Hospital and the Cardiology Department of GB Pant Hospital. Children aged one month to five years diagnosed with congenital heart disease will be included using a consecutive sampling approach. A minimum sample of one hundred children will be enrolled. Data will be collected through a pretested semi structured questionnaire administered to caregivers. Information will be gathered on sociodemographic characteristics, antenatal and birth history, onset of symptoms, caregiver response, health seeking behavior, dates related to first symptom, first presentation, and confirmed diagnosis, as well as barriers to accessing care and awareness of congenital heart disease.
The primary outcome is the proportion of children experiencing delayed diagnosis. Secondary outcomes include estimating the duration of the patient interval and the diagnostic interval, along with identifying factors associated with delays. Data will be analyzed using descriptive and inferential statistics. Written informed consent will be obtained from all caregivers and ethical approval will be secured from the Institutional Ethics Committee. |