NeoVanc LTFU
Research type
Research Study
Full title
Hearing follow up of children treated for late onset sepsis in the NeoVanc clinical trial: a cross-sectional retrospective observational study
IRAS ID
316911
Contact name
Louise Hill
Contact email
Sponsor organisation
Fondazione Penta ONLUS
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Hearing follow up of children treated for late onset sepsis in the NeoVanc clinical trial. Participants were randomised into one of two treatments, a short course optimised vancomycin dosing regimen, which included a loading dose, or a longer standard dosing regimen of vancomycin, with no loading dose. Routine hearing screening failure was twice as common in the optimised arm, which included a loading dose and more frequent dosing in babies <29 weeks postmenstrual age, compared to the standard arm. The NeoVanc LTFU study will collect follow-up hearing outcomes in babies recruited to the NeoVanc trial.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
22/YH/0245
Date of REC Opinion
10 Oct 2022
REC opinion
Favourable Opinion