Pharmacogenetics to avoid loss of hearing UK

Registry ID
ISRCTN10216938
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
University of Manchester
Enrollment
5550
Start date
2025-01-13
Completion date
2026-10-31
Last update
2026-08-17

Conditions

Summary

Use of a genetic test to detect the m.1555A>G variant associated with aminoglycoside-induced hearing loss in neonatal care units

Detailed description

This study involves a genetic test to detect the m.1555A>G variant associated with aminoglycoside-induced hearing loss. All babies admitted to the participating neonatal care units during the study period will be tested for this variant before antibiotic treatment for personalised prescribing and to avoid permanent, irreversible hearing loss in at-risk individuals. The study will take place across 14 different hospitals within the UK, chosen to achieve a variation in geography across the UK, populations and unit sizes requested within the NICE Early Value Assessment. The intervention is a one-off genetic test at the point of admission to the neonatal care unit. The objective is to examine the feasibility of incorporating the test into different size neonatal care units across the UK, rather than the efficacy of the intervention, which is already known. There is no follow-up period as part of the study.

Interventions

Inclusion criteria

All babies admitted to a study site for the defined trial period commencing from the trial start date

Exclusion criteria

Babies requiring antibiotics immediately on admission with already established IV access, where the clinical risk of waiting for the m.1555A>G result is considered, by the attending clinician, to be too great

Locations

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