PALOH (Implementation Study)
Research type
Research Study
Full title
Pharmacogenetics to Avoid Loss of Hearing (Clinical Implementation study)
IRAS ID
253102
Contact name
William Newman
Contact email
Sponsor organisation
Manchester Foundation NHS Trust
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Research Summary
Gentamicin is an antibiotic that is routinely used to treat or protect against infection in over 95% of babies admitted to Neonatal Intensive Care Units (NICUs). Some children have a genetic change (variant) that predisposes to severe hearing loss or total deafness after a single dose of gentamicin. Approximately 1 in 500 people have this variant. Groups with a higher risk of repeated chest infections throughout their lives i.e. people with cystic fibrosis, are routinely tested for this variant using a technique known as pyrosequencing. This current test takes at least three days to return a clinically relevant result. Newborn babies with suspected sepsis should be treated within the first hour of suspicion. The current genetic test is therefore unsuitable in this situation.We have developed a point-of-care test (PoCT) to detect this genetic variant via a buccal swab, delivering a reliable result in less than 40 minutes. This research study aims to trial this new genetic testing approach in two large newborn intensive care units (NICUs). The aim is to assess the performance of this device in providing an accurate result, in a time that will indicate if the child can or cannot be treated with gentamicin (a safe alternative can be used), and therefore avoid the risk of deafness.
Summary of Results
Gentamicin is an antibiotic that is routinely used to treat or protect against infection in babies admitted to Neonatal Intensive Care Units (NICUs). Some children have a genetic change (variant) that predisposes to severe hearing loss or total deafness after a single dose of gentamicin. Approximately 1 in 500 people have this variant. The current test for this variant takes at least three days to return a result. Newborn babies with suspected sepsis should be treated within the first hour of suspicion. The current genetic test is therefore unsuitable in this situation.
The aims of this project were to develop and introduce a new test for this genetic variant and assess how well this test could be integrated into current practice. We also aimed to look at staff and parent perceptions of the test and analyse potential costs associated.
We developed a point-of-care test (POCT) to detect this genetic variant, via a simple cheek swab, delivering a reliable result in less than 30 minutes. We introduced this new technology on two large neonatal units over an 11-month period. 751 babies were recruited into the trial and over 80% of those receiving antibiotics were tested successfully. 3 babies were identified as carriers of the variant and gentamicin was avoided in these individuals. Introduction of the new test was found to have no negative impact on timings for administering antibiotics.
With over 90,000 babies admitted to neonatal units in the UK, this test has the potential to avoid more than 180 cases of antibiotic induced hearing loss each year. It is expected that this test will be rolled out regionally and some further improvements made to the system to increase the success rate, before becoming available nationwide.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0400
Date of REC Opinion
1 Jul 2019
REC opinion
Favourable Opinion