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Clinical Trials/CTRI/2025/11/097489
CTRI/2025/11/097489Not yet recruitingNot Applicable

Evaluation of simple bedside algorithm to rule out critical congenital heart disease (CCHD)-A cross sectional study

JIPMER1 site in 1 country220 target enrollmentStarted: December 4, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
JIPMER
Enrollment
220
Locations
1

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
0.00 Day(s) to 28.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Gestation age less than 28 weeks Birth weight less than 1 kg.

Investigators

Sponsor
JIPMER
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Geemani Dharma Sainath Reddy

JIPMER

Study Sites (1)

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