Neonatal intensive care Neonatal Diseases
Conditions
Interventions
This study involves the use of a novel genetic test to detect the m.1555A>G variant which is associated with aminoglycoside-induced hearing loss. All neonates admitted to the participating neonatal in
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All babies admitted to NICU at Manchester University NHS Foundation Trust (MFT, Oxford Road Campus) and Liverpool Women's NHS Foundation Trust (LWH), for 6 months commencing from the trial start date 2. Babies requiring a screen for infection within 72 hours of birth (an infection screen for suspected early onset neonatal infection) at LWH who are not formally admitted to the neonatal unit, for 6 months commencing from the trial start date
Exclusion criteria
Exclusion criteria: Neonates requiring antibiotics immediately with already established IV access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total number of neonates who are successfully tested for the m. 1555A>G genetic variant out of all babies given antibiotics on admission or assessment in the two participating sites, measured using patient medical notes and real-time data collection at the end of the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The total number of neonates identified with the m. 1555A>G genetic variant, measured using retrospective data collection from device at the end of the study period 2. Average time from admission to antibiotic administration for all participants tested throughout the 6-month study period, measured using patient medical notes and real-time data collection 3. 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 4. Total number of assay failures within the 6-month testing period and the reasons for these, measured using retrospective data collection from device 5. Resource impact: additional staff time required to secure samples and undertake testing, measured using staff observations 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 7. The overall correlation of the point-of-care testing result with the current in-house reference assay (pyrosequencing) | — |
Countries
England, United Kingdom
Contacts
Public ContactRachel Mahood
Outcome results
None listed