PALOH-UK (Implementation Study)
Research type
Research Study
Full title
Pharmacogenetics to Avoid Loss of Hearing – United Kingdom [PALOH-UK]
IRAS ID
349557
Contact name
William Newman
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
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.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0854
Date of REC Opinion
6 Dec 2024
REC opinion
Further Information Favourable Opinion