Plain English Summary
Background and study aims
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.
Who can participate?
This study will focus on babies which are born prematurely between 25 and 30 weeks gestational age and are being ventilated as a high percentage of this group have previously been shown to be positive for Ureaplasma.
What does the study involve?
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 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.
What are the possible benefits and risks of participating?
The information that we aim to obtain from this study will enable neonatal teams in the future to quickly assess if a preterm baby has Ureaplasma in their lungs and may therefore help with treating that baby. Your baby will not directly benefit from participating in the study, because the results of any tests will not be made available to the team as these results will be preliminary. There are no foreseeable risks associated with participating in this study.
Where is the study run from?
Singleton Hospital, Swansea, UK
When is the study starting and how long is it expected to run for?
October 2019 to March 2021
Who is funding the study?
This study is funded by the Sir Halley Stewart Trust.
Who is the main contact?
The main contact for this study is Dr Michael Beeton (mbeeton@cardiffmet.ac.uk)
Trial website
Contact information
Type
Public
Primary contact
Dr Michael Beeton
ORCID ID
http://orcid.org/0000-0002-6292-0772
Contact details
Cardiff Metropolitan University
Llandaff Campus
Cardiff
CF5 2YB
United Kingdom
+442920205557
mbeeton@cardiffmet.ac.uk
Type
Scientific
Additional contact
Dr Michael Beeton
ORCID ID
http://orcid.org/0000-0002-6292-0772
Contact details
Cardiff Metropolitan University
Llandaff Campus
Cardiff
CF5 2YB
United Kingdom
+442920205557
mbeeton@cardiffmet.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Development of a rapid and cost-effective Point-of-Care diagnostic test for the detection of Ureaplasma infection among premature neonates
Acronym
Study hypothesis
The novel diagnostic test will be able to detect the presence of the bacteria Ureaplasma in lung secretions obtained from perterm babies.
Ethics approval
Approved 16/07/2019, London - Brighton & Sussex Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; 020 797 22567; NRESCommittee.SECoast-BrightonandSussex@nhs.net), ref: 19/LO/1285
Study design
Single centre screening study
Primary study design
Other
Secondary study design
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Bacterial infection in ventilated preterm neonates
Intervention
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 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.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Sensitivity of the new diagnostic device - estimates of the new diagnostic device positive rate in comparison with qPCR methods currently used.
2. Specificity of the new diagnostic device - estimates of the new diagnostic device negative rate in comparison with qPCR methods currently used.
3. Estimate of the positive predictive and negative predictive value of the new diagnostic device as other basic measures of diagnostic accuracy given their relationship to sensitivity and specificity through disease prevalence .
Secondary outcome measures
Relationship between qPCR copy numbers and the new diagnostic device values obtained using regression analysis
Overall trial start date
12/01/2018
Overall trial end date
30/09/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Babies born between 25 and 30 weeks gestational age
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Parents of any baby which are deemed not to have the capacity to consent
2. Parents of any baby who cannot speak English or Welsh
3. Baby receiving palliative care
4. Parents are under the age of 16 years
5. Baby under a care order
6. Any other reason that the clinical lead feels it may be inappropriate.
Recruitment start date
01/10/2019
Recruitment end date
31/03/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Singleton Hospital
Swansea
SA2 8QA
United Kingdom
Sponsor information
Organisation
Cardiff Metropolitan University
Sponsor details
Llandaff Campus
Western Avenue
Cardiff
CF5 2YB
United Kingdom
+442920205557
mbeeton@cardiffmet.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Sir Halley Stewart Trust
Alternative name(s)
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results from this study will be written up and submitted for publication in a leading scientific journals and presented at conferences. All participant details will remain anonymous.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
31/03/2022
Participant level data
Other
Basic results (scientific)
Publication list