Pharmacogenetics to Avoid Loss of Hearing (PALOH) trial: a protocol for a prospective observational implementation trial

McDermott, John Henry, Mahood, Rachel, Stoddard, Duncan, Mahaveer, Ajit, Turner, Mark A ORCID: 0000-0002-5299-8656, Corry, Rachel, Garlick, Julia, Miele, Gino, Ainsworth, Shaun, Kemp, Laura
et al (show 9 more authors) (2021) Pharmacogenetics to Avoid Loss of Hearing (PALOH) trial: a protocol for a prospective observational implementation trial. BMJ OPEN, 11 (6). e044457-.

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<h4>Introduction</h4>In conjunction with a beta-lactam, aminoglycosides are the first-choice antibiotic for empirical treatment of sepsis in the neonatal period. The m.1555A>G variant predisposes to ototoxicity after aminoglycoside administration and has a prevalence of 1 in 500. Current genetic testing can take over 24 hours, an unacceptable delay in the acute setting. This prospective-observational trial will implement a rapid point of care test (POCT), facilitating tailored antibiotic prescribing to avoid hearing loss.<h4>Methods and analysis</h4>The genedrive POCT can detect the m.1555A>G variant in 26 min from buccal swab. This system will be integrated into the clinical pathways at two large UK neonatal centres over a minimum 6-month period. The primary outcome is the number of neonates successfully tested for the variant out of all babies prescribed antibiotics. As a secondary outcome, clinical timings will be compared with data collected prior to implementation, measuring the impact on routine practice.<h4>Ethics and dissemination</h4>Approval for the trial was granted by the Research Ethics Committee (REC) and Human Research Authority in August 2019. Results will be published in full on completion of the study.<h4>Trial registration number</h4>ISRCTN13704894.<h4>Protocol version</h4>V 1.3.

Item Type: Article
Uncontrolled Keywords: neonatal intensive & critical care, genetics, audiology, adverse events, preventive medicine
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User: Symplectic Admin
Date Deposited: 10 Dec 2021 10:27
Last Modified: 18 Jan 2023 21:23
DOI: 10.1136/bmjopen-2020-044457
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