Condition category
Infections and Infestations
Date applied
07/08/2019
Date assigned
09/08/2019
Last edited
08/08/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

08/08/2019: Trial’s existence confirmed by Sir Halley Stewart Trust