PALOH (Assay validation)
Research type
Research Study
Full title
Pharmacogenetics to Avoid Loss Of Hearing (PALOH) - Assay validation study
IRAS ID
246432
Contact name
William Newman
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Gentamicin is an antibiotic that is routinely used to treat or protect against infection in over 95% of babies admitted to special care baby units, within one hour of arrival. Some individuals have a genetic change that means they will suffer severe hearing loss or total deafness after a single dose of gentamicin. Approximately 1 in 500 people have this genetic change. Groups with a higher risk of repeated chest infections throughout their lives i.e. people with cystic fibrosis, are routinely tested for this genetic change. The current test takes at least three days for results. Newborn babies need to be treated with antibiotics within one hour of arriving in the special care baby unit. The current genetic test that checks their risk of hearing loss associated with gentamicin treatment is therefore unsuitable. We have developed a quicker way to test for the defective gene. This new test involves swabbing the inside of the cheek and it can be done on newborn babies. The test can deliver a reliable result in 40 minutes. However, more extensive checks need to be done before it can be used more widely.
The main aim of the PALOH study is to test the new sampling methodology and equipment in two large special care baby units. Before we can embark on the main project, the new technology needs further validation using known positive and negative control samples. This assay validation study therefore aims to collect cheek swab samples from individuals who have previously been tested for the genetic change, to be used to certify this new test. We also aim to collect a number of samples from newborn babies, to ensure there are no factors specific to newborn samples that would affect the test.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0220
Date of REC Opinion
19 Jul 2018
REC opinion
Favourable Opinion