| CTRI Number |
CTRI/2025/11/097489 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using a Simple Echo Check to Detect Serious Heart Problems in Newborns |
|
Scientific Title of Study
|
Evaluation of simple bedside algorithm to rule out critical congenital heart disease (CCHD)-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 |
Geemani Dharma Sainath Reddy |
| Designation |
Senior residentt |
| Affiliation |
JIPMER |
| Address |
Department of Neonatology, JIPMER
Pondicherry PONDICHERRY 605006 India |
| Phone |
8688337389 |
| Fax |
|
| Email |
dharmasainath@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Murugesan A |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Neonatology, JIPMER
Pondicherry PONDICHERRY 605006 India |
| Phone |
9442455767 |
| Fax |
|
| Email |
murugesan89@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Murugesan A |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Neonatology, JIPMER
PONDICHERRY 605006 India |
| Phone |
9442455767 |
| Fax |
|
| Email |
murugesan89@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER, PONDICHERRY, PINCODE 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
PONDICHERRY, PINCODE 605006 |
| 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 Murugesan A |
Neonatalology ICU |
Department of Neonatology, JIPMER Pondicherry PONDICHERRY |
9442455767
murugesan89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES,JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I30-I52||Other forms of heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Any neonate with clinical suspicion of CCHD. Examples PPHN, shock, persistent respiratory requirement, Failed pulse oximetry screen
Multiple malformations syndrome (MMS)
Preoperative cardiac evaluation for neonates posted for major surgeries
|
|
| ExclusionCriteria |
| Details |
Gestation age less than 28 weeks
Birth weight less than 1 kg |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic concordance between simple NPE algorithm and pediatric cardiologist in ruling out critical congenital heart disease in neonates |
Echo will be reviewed by cardiologist at 6 hours if baby is sick and 24 hours if baby is stable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The time needed to complete all seven views in the proposed algorithm for ruling out critical congenital heart disease.
Proportion of infants diagnosed with any other heart disease other than critical congenital heart disease during the examination.
Agreement between neonatology resident, neonatology consultant & paediatric cardiologist in various views & structures & for ruling out critical congenital heart disease
Proportion of infants in whom images & videos were inconclusive to rule out CCHD & required repeat sonography by cardiologist. |
Cardiologist will review the echo at 6 hours if baby is sick & at 24 hours if baby is stable
Time taken to complete echo will be noted by other resident or nursing staff |
|
|
Target Sample Size
|
Total Sample Size="220" Sample Size from India="220"
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)
|
04/12/2025 |
| 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="2" Months="0" 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
|
Introduction CCHD is one of the important cause for hemodynamic instability in the newborn period. In cases where CCHD is suspected, waiting for a cardiologist-performed echocardiogram can be time-consuming. A structured algorithm-based approach using trained Neonatologist-Performed Echocardiography (NPE) can facilitate the rapid exclusion of CCHD, enabling quicker decision-making and improved clinical outcomes. Rationale In critically ill neonates, ruling out CCHD is an essential part of routine NICU management. A detailed cardiac evaluation by a cardiologist is not always necessary. A simple algorithm-based NPE approach can effectively rule out CCHD in most cases. Bedside echocardiography performed by trained neonatologists serves as a valuable tool and significantly reduces unnecessary cardiology referrals. Novelty This study is novel in its approach to ruling out CCHD using a seven-point bedside echocardiographic assessment and evaluating the time required for completion. The findings will help develop a structured algorithm, demonstrating how neonatologists can rule out critical heart defects. Currently, this algorithmic approach is not routinely implemented in the NICU, highlighting the need for standardized integration into clinical practice.
Expected Outcome and Application This study aims to establish an algorithmic approach for ruling out CCHD in neonates with conditions that mimic the disease. If a strong agreement is found between NPE and cardiologist-performed echocardiography, unnecessary bedside referrals can be minimized. Additionally, the structured algorithm may help reduce the time required for echocardiographic assessment. If proven effective, training neonatologists in this algorithm based approach could help in rapid and accurate bedside clinical management. | |