跳至主要内容
临床试验/CTRI/2025/11/097489
CTRI/2025/11/097489尚未招募不适用

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

JIPMER1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年12月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
JIPMER
入组人数
220
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • 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.

排除标准

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

研究者

发起方
JIPMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Geemani Dharma Sainath Reddy

JIPMER

研究点 (1)

Loading locations...

相似试验