Early detection of congenital heart disease aided by Mobile App based Echo-integrated diagnostic tool
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 6
- 主要终点
- Interobserver agreement of categorization & initial recommendation by neonatologist using APP tool versus Pediatric Cardiologist.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 30.00 Day(s)(—)
- 性别
- All
入选标准
- •Any neonate admitted to participating NICU suspected to have Critical congenital heart disease.
排除标准
- •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.
结局指标
主要结局
Interobserver agreement of categorization & initial recommendation by neonatologist using APP tool versus Pediatric Cardiologist.
时间窗: at the end of study
次要结局
- 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)
研究者
Dr Navaneetha Sasikumar
Dept. of Pediatric Cardiology, Amrita Institute of Medical Sciences & Research Center
