Quick bedside tests in newborns
| ISRCTN | ISRCTN15554320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15554320 |
| IRAS number | 352977 |
- Submission date
- 11/12/2024
- Registration date
- 15/01/2025
- Last edited
- 15/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
We wish to explore targeted testing in neonatal intensive care to help decision-making around the best management of an unwell baby. The tests we explore will be currently or potentially deliverable using point of care tests (POCT) – these give rapid answers to clinical teams.
Who can participate?
Babies admitted to the neonatal unit being investigated or managed for possible infection or bowel problems.
What does the study involve?
We will use targeted sampling of blood, urine, stool or saliva over the first hours and days after a baby becomes unwell to see how different tests might help teams when management decisions are being made. These include decisions around antibiotic duration, pausing or restarting milk feeds, and types and amounts of fluids and intravenous feeds being given. We have chosen POCT based on what is already known about sick babies but are not yet used as part of normal care. The POCT results will not be shared with the clinical team and will not change care delivered. We will explore whether they perform well enough to help guide management decisions like stopping or re-starting feeds, stopping, reducing or re-starting intravenous nutrition, duration of antibiotics etc. We will also examine illness scores and how they correlate with POCT. We will also explore how clinical teams currently make decisions and how they would ‘value’ additional POCT information. The study is being undertaken as a higher degree (MD) by a medical doctor. The findings will help inform the design of a future study where clinicians would be given the results in real time to guide decision-making.
What are the possible benefits and risks of participating?
There are no real benefits as the results will not be known to the clinical teams at this stage because we do not know if they will work well enough to help make decisions. The only risk is that the blood that is taken is extra to clinical need. This is clear to families in information and on consent sheets. We will take the smallest amount possible for the tests and will adhere to current guidance on volumes of blood that can be taken from small babies.
Where is the study run from?
Royal Victoria Infirmary (UK)
When is the study starting and how long is it expected to run for?
September 2024 to August 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Janet Berrington, janet.berrington1@nhs.net
Contact information
Public, Scientific, Principal Investigator
Ward 35
Neonatal Unit
Royal Victoria Infirmary
Newcastle
NE1 4LP
United Kingdom
 ORCID ID |
0000-0002-6185-2843 |
|---|---|
| Phone | +44 (0)191 2829323 |
| janet.berrington1@nhs.net |
Study information
| Study design | Observational cohort longitudinal single-centre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Includes some qualitative elements |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participation information sheet |
| Scientific title | Neonatal Quick Assays (NeoQUACK): an observational study of neonates in intensive care units and the application of point-of-care tests to assist clinical decision making |
| Study acronym | NeoQUACK |
| Study objectives | We wish to explore targeted testing in neonatal intensive care to help decision-making around the best management of an unwell baby. The tests we explore will be currently or potentially deliverable using point of care tests (POCT) – these give rapid answers to clinical teams. We will use targeted sampling of blood, urine, stool or saliva over the first hours and days after a baby becomes unwell to see how different tests might help teams when management decisions are being made. These include decisions around antibiotic duration, pausing or restarting milk feeds, and types and amounts of fluids and intravenous feeds being given. We have chosen POCT based on what is already known about sick babies but are not yet used as part of normal care. The POCT results will not be shared with the clinical team and will not change care delivered. We will explore whether they perform well enough to help guide management decisions like stopping or re-starting feeds, stopping, reducing or re-starting intravenous nutrition, duration of antibiotics etc. We will also examine illness scores and how they correlate with POCT. We will also explore how clinical teams currently make decisions and how they would ‘value’ additional POCT information. The study is being undertaken as a higher degree (MD) by a medical doctor. The findings will help inform the design of a future study where clinicians would be given the results in real time to guide decision making. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Infant admitted to the neonatal intensive care unit undergoing testing for suspected (or confirmed) infection, or bowel concerns |
| Intervention | No changes to clinical care. Point of care tests will be performed on saliva, stool, blood or urine, from beginning of screening episode to physiological and nutritional recovery, discharge from the neonatal unit, withdrawal or death whichever is sooner. |
| Intervention type | Other |
| Primary outcome measure | For each assay: positive and negative predictive values for each diagnostic category and area under the curve analysis to identify the best cut-off values from the time of screening to full physiological recovery |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2024 |
| Completion date | 31/08/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Lower age limit | 0 Days |
| Upper age limit | 6 Months |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Infant admitted to the neonatal intensive care unit (from 22 weeks gestation to 6 months postnatal age) 2. Infant undergoing testing for suspected (or confirmed) infection, or bowel concerns 3. Written informed consent from parents |
| Key exclusion criteria | 1. Parents unwilling to consent 2. Infants being screened at or shortly after birth for risk factors alone but who are clinically well 3. Infants known to have severe multi-system congenital abnormalities. Infants known to have congenital gastrointestinal abnormalities at admission will be excluded for the first 48 hours, but eligible after this if infection or new bowel concerns occur 4. Infants undergoing therapeutic hypothermia |
| Date of first enrolment | 01/03/2025 |
| Date of final enrolment | 28/02/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ward 35
Newcastle
NE1 4LP
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| Phone | +44 (0)191 2824519 |
|---|---|
| nuth.nuthsponsorship@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 28/02/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers will publish in peer-reviewed journals |
| IPD sharing plan | The datasets generated and/or analysed during the current study may be available on request from Prof. Janet Berrington (janet.berrington1@nhs.net) |
Editorial Notes
19/12/2024: Study's existence confirmed by the Newcastle upon Tyne Hospitals NHS Foundation Trust.
