Use of a genetic test to detect the m.1555A>G variant associated with aminoglycoside-induced hearing loss in neonatal care units Neonatal Diseases
Conditions
Interventions
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 pe
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
0 Days to 5 Years
Inclusion criteria
Inclusion criteria: All babies admitted to a study site for the defined trial period commencing from the trial start date
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of neonates who are successfully tested for the m. 1555A>G genetic variant out of all babies given antibiotics measured using genetic testing data on admission or assessment at the participating sites | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The total number of neonates identified with the m. 1555A>G genetic variant, measured using retrospective data collection from the device at the end of the study period 2. The frequency of different antibiotic regimens used, measured using data recorded during the collection periods, will be summarised by descriptive statistics, across the whole study and by site at the end of the study period. The antibiotic used for any baby positive for the m.1555A>G variant will also be reported. 3. Average time from admission to antibiotic administration for all participants tested throughout the study period, across all sites, measured using aggregate data collection at the end of the study period 4. Total number of incidences where time to antibiotic administration exceeds the 60-minute target and the reasons for these, measured using patient medical notes and real-time data collection at the end of the study period 5. Total number of assay failures within the testing period and whether this varies based on geography and/or site size, and the reasons for these, measured using retrospective data collection from the device at the end of the study period 6. Total number of babies where testing was not undertaken during the 6-month testing period and the reasons for these, measured using patient medical notes and real-time data collection at the end of the study period 7. Diagnostic accuracy measured using Sanger sequencing to assess sensitivity, specificity, accuracy, positive predictive value, and negative predictive values at the end of the study 8. Ethnicity measured using self-reported ethnicity data at the end of the study | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactSian Hilton
Outcome results
None listed