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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Sian
Hilton
SIAN.HILTON@MFT.NHS.UK
Prof
William
Newman
william.newman@manchester.ac.uk
Other disorders of earDrugs, medicaments and biological substances causing adverse effects in therapeutic use
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Gentamicin is an antibiotic that is given to babies within one hour of being admitted to neonatal units. The antibiotic can treat and / or protect them against infections. However, some babies have a small difference in their genetic make-up which means they will develop severe hearing loss or total deafness even after a single dose of gentamicin. This affects around 1in500 babies.
A genetic test can be done from a cheek swab that would tell doctors and nurses quickly if a baby was at risk of hearing loss if given gentamicin. We used this test in a previous research study called PALOH to see how it would work in practice and 750 babies admitted to the neonatal intensive care unit in Manchester had the new genetic test. Within 26 minutes, we could tell who would be at risk if given gentamicin, without causing any delays to babies being given the antibiotics. Three out of the 750 babies were found to be at risk of hearing loss and were given an alternative antibiotic.
In this new study, we will work with 14 different neonatal units in England, Scotland, Wales and Northern Ireland, testing over 5000 babies. Babies admitted over a 6-month period at each site will be eligible to be part of the study. A cheek swab will be taken from the babies and nurses will run the genetic test as part of their standard of care. We will use the excess samples and information to show the test can be used in timely way to ensure babies get a safe, effective antibiotic. This study will help to get information to allow wider use of the genetic test.
We will also expand our work with parent and health care staff opinions about the test and the cost implications of introducing the test.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
Babies requiring antibiotics immediately on admission with already established IV access, where the clinical risk of waiting for the m.1555A> G result is considered, by the attending clinician, to be too great.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Manchester and funded by NIHR Central Commissioning Facility (CCF) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 65537
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
