RecruitingObservational

Pharmacogenetics to avoid loss of hearing UK

The 'Pharmacogenetics to avoid loss of hearing UK' study looks at using a new, fast genetic test for babies in neonatal units. For about 1 in 500 babies, a common antibiotic called gentamicin can cause severe hearing loss or deafness due to a specific gene. This genetic test helps doctors quickly identify these babies so they can be given a different, safer antibiotic instead. The aim is to prevent avoidable hearing loss in newborns. The study will test how well this new genetic test works in 14 different hospitals across the UK, gathering opinions from parents and staff, and checking its cost-effectiveness for the NHS.

At a glance

Status

Recruiting

Sponsor

University of Manchester

Enrolment target

5,550

Start

13 Jan 2025

Estimated completion

31 Oct 2026

Use of a genetic test to detect the m.1555A>G variant associated with aminoglycoside-induced hearing loss in neonatal care units

What is this study about?

When newborn babies are admitted to hospital, especially if they're unwell, doctors often give them an antibiotic called gentamicin to treat or prevent infections. It's a very effective medication. However, we know that about 1 in every 500 babies has a specific genetic difference. If these babies are given gentamicin, even just one dose, it can unfortunately lead to severe hearing loss or even complete deafness.

Traditionally, finding out if a baby has this genetic difference takes time – sometimes days. This study is looking at a new, rapid genetic test that can give results in under half an hour. This quick result means doctors can find out almost immediately if a baby is at risk. If a baby is found to be at risk, they can then be given a different antibiotic that won't harm their hearing, while still treating their infection effectively.

This study will take place in 14 neonatal units across England, Scotland, Wales, and Northern Ireland. Its main goal is to show that this quick genetic test works well across different hospitals and helps ensure babies receive the safest antibiotic treatment right from the start. Researchers also want to understand what parents and healthcare staff think about the test, and how much it might cost the NHS to use it more widely.

Key takeaways

A rapid genetic test can identify babies at risk of hearing loss from gentamicin.
The test helps doctors choose safer antibiotics quickly.
The study aims to prevent avoidable hearing loss in newborns.
It's being tested in 14 UK hospitals to assess its effectiveness and cost.
The test is quick, non-invasive, and has minimal risks.
Your baby's safety and well-being are the top priority throughout the study.

Who may be eligible?

Generally, if your baby is admitted to one of the 14 neonatal units taking part in this study during the study period, they would typically be included. Babies of all genders and between birth and five years old can be considered.

However, there are some situations where a baby might not be able to take part. For example, if a baby needs antibiotics extremely urgently right after being admitted to the hospital, and they already have a way to receive medicine directly into their bloodstream (like an IV drip), the doctor might decide it's too risky to wait even the short time the genetic test takes. In such cases, the medical team will make the best decision for your baby's immediate health and treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your baby admitted to a neonatal unit that is part of this study?
Is your baby within the age range of 0 days to 5 years?
Does your baby need antibiotics for an infection?
Has the medical team assessed that it is safe to wait a short time (under 30 minutes) for the test result before starting antibiotics if necessary?

Answer every question to see your result.

What does participation involve?

If your baby is part of this study, it simply means that when they are admitted to a participating neonatal unit and need antibiotics, they will have a quick genetic test performed. This test is non-invasive, meaning it doesn't involve needles or discomfort; it's usually done using a small swab, similar to a cotton bud. The results from this test will help doctors decide if gentamicin is a safe antibiotic for your baby or if another option would be better.

There are no extra visits or special medications beyond what your baby would already receive for their care. The study aims to fit smoothly into the usual care provided in the neonatal unit. Researchers will also be gathering opinions from parents and healthcare staff about the test. The study is expected to run from January 2025 to October 2026.

Potential risks and benefits

The main benefit of your baby taking part is that it helps identify very quickly if they are at risk of hearing loss from a common antibiotic, allowing doctors to choose a safer treatment for them immediately. This could prevent avoidable hearing loss and potentially save the NHS money in the long run. The risks are considered very small, as the genetic test is quick and doesn't involve anything invasive or uncomfortable. It's important to remember that your baby's care and safety are always the top priority, and you have the right to ask questions or decide not to have your baby participate in the genetic testing part of the study at any time without affecting their medical care.

Locations (12)

Manchester University NHS Foundation Trust
City only
Manchester, England
Belfast Health and Social Care Trust
City only
Belfast, Northern Ireland
University Hospitals Sussex NHS Foundation Trust
City only
Worthing, England
NHS Greater Glasgow and Clyde
City only
Glasgow, Scotland
Royal Bolton Hospital
Approximate
Bolton, England
Tameside and Glossop Integrated Care NHS Foundation Trust
Unverified
Ashton-under-lyne, England
Norfolk and Norwich University Hospital
Unverified
Norwich, England
Betsi Cadwaladr University Lhb
Unverified
Bangor, Wales
Cardiff & Vale University Lhb
Unverified
Cardiff, Wales
Stockport NHS Foundation Trust
Unverified
Stockport, England
Wrightington, Wigan and Leigh NHS Foundation Trust
Unverified
Wigan, England
Royal Oldham Hospital
Unverified
Oldham, England

Common questions

What is gentamicin and why is it sometimes a problem?

Gentamicin is a common antibiotic for babies with infections. For a small number of babies (about 1 in 500) who have a specific genetic difference, gentamicin can unfortunately cause severe hearing loss.

What is this new genetic test and how does it work?

It's a quick test that checks for a specific gene that makes some babies sensitive to gentamicin. It's non-invasive, usually a simple swab, and gives results in under 30 minutes, much faster than traditional tests.

Will my baby get different care if they are in the study?

Your baby will receive the best possible care regardless. The study aims to help doctors choose the safest antibiotic for your baby based on the rapid genetic test result, fitting into standard care.

Are there any risks to my baby from this genetic test?

The risks are considered very low. The test is quick, non-invasive (like a swab), and doesn't involve any discomfort or side effects for your baby.

Who is running and paying for this study?

The University of Manchester is coordinating the study, and it's funded by the National Institute for Health Research (NIHR) and the Office for Life Sciences (OLS).

How to find out more

Sian Hilton

Sian.Hilton@mft.nhs.uk +44 (0)7977741953 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.