Point-of-care diagnostic test for neonatal infection
| ISRCTN | ISRCTN17907106 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17907106 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Cardiff Metropolitan University |
| Funder | Sir Halley Stewart Trust |
- 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
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
Public
Cardiff Metropolitan University, Llandaff Campus
Cardiff
CF5 2YB
United Kingdom
 ORCID ID |
0000-0002-6292-0772 |
|---|---|
| Phone | +442920205557 |
| mbeeton@cardiffmet.ac.uk |
Scientific
Cardiff Metropolitan University, Llandaff Campus
Cardiff
CF5 2YB
United Kingdom
| ORCID ID |
0000-0002-6292-0772 |
|---|---|
| Phone | +442920205557 |
| mbeeton@cardiffmet.ac.uk |
Study information
| Primary study design | Other |
|---|---|
| Study design | Single centre screening study |
| Secondary study design | |
| Study type | Participant information sheet |
| Scientific title | Development of a rapid and cost-effective Point-of-Care diagnostic test for the detection of Ureaplasma infection among premature neonates |
| Study objectives | The 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) studied | 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 |
| Primary outcome measure(s) |
1. Sensitivity of the new diagnostic device - estimates of the new diagnostic device positive rate in comparison with qPCR methods currently used. |
| Key secondary outcome measure(s) |
Relationship between qPCR copy numbers and the new diagnostic device values obtained using regression analysis |
| Completion date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | Babies born between 25 and 30 weeks gestational age |
| Key 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. |
| Date of first enrolment | 01/10/2019 |
| Date of final enrolment | 31/03/2021 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
SA2 8QA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
