Pharmacogenetics to avoid loss of hearing

Not Applicable

Completed

• Conditions: eonatal intensive care; Neonatal Diseases

• Registration Number: ISRCTN13704894
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34135034/ (added 18/06/2021) 2022 Results article in https://jamanetwork.com/journals/jamapediatrics/fullarticle/2790066 (added 08/06/2022) 2024 Results article in https://doi.org/10.1111/jan.16045 qualitative study (added 08/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-25
• Study Completion: 2020-11-30
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 900

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

Neonates requiring antibiotics immediately with already established IV access

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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