40
Participants
Start Date
November 10, 2024
Primary Completion Date
March 31, 2026
Study Completion Date
July 31, 2026
First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg/L)
CALCULATOR: A 'First-dose trough dose adjustment calculator' was developed based on a population pharmacokinetic model. A participant's post-menstrual age, weight, creatinine, target trough concentration, dose, dosing interval and first-dose trough concentration (taken immediately before the second dose is due) are entered into the calculator. The calculator determines if a dose adjustment is required (based on whether the predicted steady-state trough concentration is \<10mg/L or \>20mg/L) and, if required, recommends a new adjusted dose.
RECRUITING
Royal Children's Hospital Melbourne, Melbourne
NOT_YET_RECRUITING
Monash Newborn, Melbourne
NOT_YET_RECRUITING
Royal Hospital for Women, Sydney
RECRUITING
The Children's Hospital at Westmead, Sydney
Lead Sponsor
Collaborators (1)
Royal Children's Hospital
OTHER
Royal Hospital For Women
OTHER
Sydney Children's Hospitals Network
OTHER
Monash Health
OTHER
Murdoch Childrens Research Institute
OTHER