| CTRI Number |
CTRI/2024/06/068391 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non interventional descriptive Prospective study |
| Study Design |
Other |
|
Public Title of Study
|
Timely detection of critical congenital heart disease by Paediatricians aided by a mobile application |
|
Scientific Title of Study
|
Early detection of congenital heart disease aided by Mobile App based Echo-integrated
diagnostic tool |
| 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 Navaneetha Sasikumar |
| Designation |
Associate Professor |
| Affiliation |
Dept. of Pediatric Cardiology, Amrita Institute of Medical Sciences & Research Center |
| Address |
Department of Pediatric Cardiology, Amrita Institute of Medical Sciences & Research Center, Ponekkara, AIMS P O Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9706048664 |
| Fax |
|
| Email |
drnavni@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navaneetha Sasikumar |
| Designation |
Associate Professor |
| Affiliation |
Dept. of Pediatric Cardiology, Amrita Institute of Medical Sciences & Research Center |
| Address |
Department of Pediatric Cardiology, Amrita Institute of Medical Sciences & Research Center, Ponekkara, AIMS P O Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9706048664 |
| Fax |
|
| Email |
drnavni@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navaneetha Sasikumar |
| Designation |
Associate Professor |
| Affiliation |
Dept. of Pediatric Cardiology, Amrita Institute of Medical Sciences & Research Center |
| Address |
Department of Pediatric Cardiology, Amrita Institute of Medical Sciences & Research Center, Ponekkara, AIMS P O Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9706048664 |
| Fax |
|
| Email |
drnavni@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Funding agency - Women as One organisation, USA |
|
|
Primary Sponsor
|
| Name |
Women as One organisation |
| Address |
87 Kenilworth Rd.
Asheville, NC 28803 USA |
| Type of Sponsor |
Other [US organization for advancing careers of women in cardiology] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gokuldas |
Aster MIMS, Kannur |
Chala East, Chala, Kerala
Kannur
KERALA |
9496356577
gokuldaspk@gmail.com |
| Dr Vaishnavi Raman |
ESIC Medical College & PGIMSR |
K.K Nagar, Chennai
Chennai
TAMIL NADU |
9585996484
dr.vaishnavipaeds@gmail.com |
| Dr Febi Francis |
Government Medical College, Thrissur |
Government Medical College, Medical College P.O Thrissur
Thrissur
KERALA |
9095102204
febifrancis@gmail.com |
| Dr Prathik B H |
Indira Gandhi Institute of Child Health |
South Hospital Complex, Dharmaram College Post, Near Nimhans, Bengaluru
Bangalore
KARNATAKA |
9717235721
prathikbh@gmail.com |
| Dr Shaad Abqari |
Jawaharlal Nehru Medical College & Hospital |
Jawaharlal Nehru Medical College & Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh, U.P
Aligarh
UTTAR PRADESH |
9557906968
drshaadabqari@gmail.com |
| Dr Akkatai S Teli |
Kasturba Medical College & Hospital, Manipal |
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA |
8904819510
drakssteli@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee Aster MIMS, Kannur, Malabar Institute of Medical Sciences Ltd, Kannur, |
Approved |
| Ethics Committee of Amrita School of Medicine, Kochi, Kerala |
Approved |
| Institutional Ethics Committe, ESIC Medical College & PGIMSR, Chennai |
Approved |
| Institutional Ethics Committee Indira Gandhi Institute of Child Health, Bangalore, Karnataka |
Approved |
| Institutional Ethics Committee Jawaharlal Nehru Medical College & Hospital, A.M.U, Aligarh |
Approved |
| Institutional Ethics Committee, Government Medical College, Thrissur |
Approved |
| Kasturba medical college and kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q20-Q28||Congenital malformations of the circulatory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Any neonate admitted to participating NICU suspected to have Critical congenital heart disease |
|
| ExclusionCriteria |
| Details |
Neonates prenatally diagnosed to have CHD will be excluded from the study. Neonates with suspected CHD whose condition merits urgent initiation of treatment and resuscitation such that a Neonatologist performed echocardiogram for the study purpose would delay care, will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Interobserver agreement of categorization & initial recommendation by neonatologist using APP tool versus Pediatric Cardiologist. |
at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| identify scenarios where APP algorithm fails compared to pediatric cardiologist diagnosis |
at the end of study |
| Interobserver agreement of categorization & initial recommendation by neonatologist using APP tool versus Pediatric Cardiologist. |
at the end of 6 months |
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="5000"
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)
|
01/07/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Critical congenital heart diseases contribute to a large number of deaths in newborn babies and infants. Timely diagnosis is key to saving lives. The availability of trained personnel to perform and interpret a neonatal echocardiogram with a reasonable degree of accuracy poses a significant challenge in early detection of CCHD. Number of trained Pediatric Cardiologists is too low compared to the number of newborns. The smiling heart App was developed to bridge this large gap. The app has an innovative tool that aids in performing Echocardiography at the bedside, facilitating timely diagnosis and referral. Early detection and timely referral will help to save lives of these babies.The hypothesis is that with the help of the app, neonates who need urgent care /referal to a higher center can be identified by the treating pediatricians and neonatologists, without the need of a pediatric cardiologist. The project focuses on evaluating the real world utility of the App based tool to assist Neonatologists/Pediatricians in early detection of critical congenital heart disease. Inter observer agreement between diagnosis and recommendations made by the neonatologists with the help of the app will be done with that made by Pediatric Cardiologists with the help of the app as well as without the app. The study needs to cover 5000 neonatal ICU admissions and is planned as a multicentre project to meet this requirement. |