PALOH-UK Qualitative Study
Research type
Research Study
Full title
Pharmacogenetics to Avoid Loss of Hearing (PALOH) trial UK [PALOH-UK] – Qualitative sub-study exploring the implementation of the RNR1 point of care genetic test
IRAS ID
354050
Contact name
Paul Wilson
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
NHS002232 , Sponsor Reference Number
Duration of Study in the UK
1 years, 8 months, 4 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 within 26 minutes if a baby was at risk of hearing loss if given gentamicin. This test was used in a previous research study called PALOH to see how it would work in practice. 750 babies admitted to the neonatal intensive care unit in Manchester had the new genetic test. Three were found to be at risk of hearing loss and were given an alternative antibiotic.
In the PALOH-UK Trial, 14 different neonatal units in England, Scotland, Wales and Northern Ireland, will test over 5000 babies. A cheek swab will be taken from the babies and nurses will run the genetic test as part of their standard care.
As part of the PALOH-UK Trial, we will be conducting a qualitative study to assess the feasibility and acceptability of implementing the new test into routine care from both provider and parent perspectives. We will conduct interviews with parents/carers and providers. We will ask questions to understand providers’ views on the new test, how they feel it compares to existing practices, and how it is incorporated into the care pathways. We will also ask providers and parents/carers about any barriers or enablers to the test. Interviews will last up to one hour and be conducted online or over the telephone. This study will help to get information to allow wider use of the test.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
25/SW/0024
Date of REC Opinion
18 Mar 2025
REC opinion
Favourable Opinion