PALOH parent study
Research type
Research Study
Full title
Exploring parents' attitudes to point-of-care genetic testing in the PALOH trial.
IRAS ID
261257
Contact name
Fiona Ulph
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 0 months, 13 days
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). Approximately 1 in 500 people have a genetic variant that predisposes to severe hearing loss or total deafness after a single dose of gentamicin. A new point-of-care test (PoCT) for the variant has been developed which delivers a reliable result in under 40 minutes (if the variant is present, a safe alternative antibiotic can be used, preventing hearing loss). The PALOH clinical implementation research study (IRAS ID: 253102) will trial the new genetic test in two large newborn intensive care units (NICUs). In order to fully assess the PoCT, a qualitative study is necessary to interview parents to explore their experiences of taking part in the PALOH trial. This will explore practical issues, for instance evaluation of the information and communication they were given on the NICU, in order that potential issues may be identified and addressed in clinical practice. However, parent interviews will also explore more wide-reaching questions about genetics – for example, parents’ awareness and understanding of genetics; and their attitudes to genetic screening generally.
As the UK is set to increasingly integrate genetics into health care (Davies, 2016), qualitative exploration of such issues is important, in order to anticipate potential barriers to integration and understanding.
The study will be recruiting from the two NHS sites involved in the main PALOH trial (Manchester University NHS Foundation Trust and Liverpool Womens NHS Foundation Trust) and is funded by the NIHR invention for innovation ref:II-LB-0417-20002.REC name
North West - Preston Research Ethics Committee
REC reference
20/NW/0068
Date of REC Opinion
24 Mar 2020
REC opinion
Favourable Opinion