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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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