Point-of-care diagnostic test for neonatal infection v1
Research type
Research Study
Full title
Development of a rapid and cost-effective Point-of-Care diagnostic test for the detection of Ureaplasma infection among premature neonates
IRAS ID
250778
Contact name
Michael Beeton
Contact email
Sponsor organisation
Cardiff Metropolitan University
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Being born before 37 weeks of pregnancy, also known as premature birth, is the leading cause of death among babies. Around 60 000 babies are born early in the UK each year with 40% of cases being associated with an infection. Among these cases the most commonly isolated bacteria are Ureaplasma. Ureaplasma in the lungs of the premature babies has been associated with an increased risk of lung disease, damage to the gut and bleeding on the brain compared with babies born early but are not infected. Administration of the correct antibiotic has been shown to eradicate Ureaplasma from the lungs, but a specific type of antibiotic (azithromycin) is required to treat these babies, one which is not given as routine practice. It is therefore imperative to obtain a rapid diagnosis of Ureaplasma to administer the correct treatment, but current diagnostic methods are expensive and take many days to obtain a result.
This study will look at the feasibility of a newly developed diagnostic device to detect Ureaplasma among premature neonates. This study will focus on babies which are born prematurely between 25 and 30 weeks gestational age as a high percentage of this group have previously been shown to be positive for Ureaplasma.
As part of routine care, ventilator tubes are cleared of mucus which can build up over time. It is this waste material, which we will use to assess the feasibility of the the new device to detect Ureaplasma. Samples will be collected over an 18 month period from babies admitted to the Neonatal Intensive Care Unit at Singleton Hospital, Swansea. Samples will be run on the new device and compared to the current accepted method at Cardiff Metropolitan University. Due to the developmental nature of this study, results will not be used to inform clinical practice.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
19/LO/1285
Date of REC Opinion
16 Jul 2019
REC opinion
Favourable Opinion