Point-of-care diagnostic test for neonatal infection

ISRCTN ISRCTN17907106
DOI https://doi.org/10.1186/ISRCTN17907106
Submission date
07/08/2019
Registration date
09/08/2019
Last edited
20/09/2023
Recruitment status
Suspended
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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)

Contact information

Dr Michael Beeton
Public

Cardiff Metropolitan University, Llandaff Campus
Cardiff
CF5 2YB
United Kingdom

ORCiD logoORCID ID 0000-0002-6292-0772
Phone +442920205557
Email mbeeton@cardiffmet.ac.uk
Dr Michael Beeton
Scientific

Cardiff Metropolitan University, Llandaff Campus
Cardiff
CF5 2YB
United Kingdom

ORCiD logoORCID ID 0000-0002-6292-0772
Phone +442920205557
Email mbeeton@cardiffmet.ac.uk

Study information

Study designSingle centre screening study
Primary study designOther
Secondary study design
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleDevelopment of a rapid and cost-effective Point-of-Care diagnostic test for the detection of Ureaplasma infection among premature neonates
Study objectivesThe novel diagnostic test will be able to detect the presence of the bacteria Ureaplasma in lung secretions obtained from perterm babies.
Ethics approval(s)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
Health condition(s) or problem(s) studiedBacterial infection in ventilated preterm neonates
InterventionAs 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 typeOther
Primary outcome measure1. 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 measuresRelationship between qPCR copy numbers and the new diagnostic device values obtained using regression analysis
Overall study start date12/01/2018
Completion date30/09/2021

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants100
Key inclusion criteriaBabies born between 25 and 30 weeks gestational age
Key exclusion criteria1. 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.
Date of first enrolment01/10/2019
Date of final enrolment31/03/2021

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Singleton Hospital
Swansea
SA2 8QA
United Kingdom

Sponsor information

Cardiff Metropolitan University
University/education

Llandaff Campus
Western Avenue
Cardiff
CF5 2YB
Wales
United Kingdom

Phone +442920205557
Email mbeeton@cardiffmet.ac.uk
ROR logo "ROR" https://ror.org/00bqvf857

Funders

Funder type

Charity

Sir Halley Stewart Trust
Private sector organisation / Other non-profit organizations
Location
United Kingdom

Results and Publications

Intention to publish date31/03/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planThe 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 planAll data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 20/09/2023 No No

Editorial Notes

20/09/2023: A link to the HRA research summary was added.
05/05/2020: Due to current public health guidance, recruitment for this study has been paused.
08/08/2019: Trial’s existence confirmed by Sir Halley Stewart Trust