RAPID-Wales
Research type
Research Study
Full title
Clinical investigation to establish acceptance and feasibility of a novel Rapid Automated Paediatric Imaging Device (RAPID) to screen infants for heart abnormalities
IRAS ID
340703
Contact name
Emma Rees
Contact email
Sponsor organisation
Bloom Standard
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Approximately 1% of newborns worldwide are born with congenital heart disease (CHD), a group of congenital defects that affects the heart structure and/or function. Globally, approximately 180,000 infants under 1 year old died from CHD in 2017.
Early and accurate diagnosis is key to reducing the number of babies and infants who die from CHD. For the most severe types of CHD defects early diagnosis has been shown to reduce the mortality rate from 27% to 16%.
Currently, the best way to screen and diagnose CHD is using ultrasound to image the heart (echocardiography) which is difficult to learn and do.
This is a pilot study to investigate a prototype ultrasound device that aims to make it easier for healthcare professionals to take ultrasound images of the heart. These images can then be used to screen for CHD so that the most unwell infants can be seen quickly. The device has had significant safety and biocompatibility testing and has been used on over 100 babies.
In this study, 30 clinically well babies who are attending an outpatient heart murmur clinic in Singleton Hospital, Swansea, will receive an extra set of ultrasound scans at the end of their appointment. Data will be collected on how well the device performed, such as any technical issues, and how the sonographers felt about the device. The parents will also be asked for feedback on how they felt about the device and the study.
At the end of the study, an independent expert will look at the images and give feedback on whether the quality is good enough to use them to screen for CHD.
Results from this study will be used to shape a larger second study, which will collect more in-depth data about the device and its usability.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
25/WM/0240
Date of REC Opinion
24 Nov 2025
REC opinion
Favourable Opinion