26
Participants
Start Date
July 4, 2024
Primary Completion Date
July 31, 2026
Study Completion Date
July 31, 2027
Standard Dose - Ibuprofen oral suspension
Standard dosing administers ibuprofen without adjustments, starting with an initial loading dose followed by two maintenance doses at 24-hour intervals: 10/5/5 mg/kg for infants aged ≤72 hours, and 20/10/10 mg/kg for those \>72 hours old.
Precision Dose - Ibuprofen oral suspension
Precision Dosing (Model-Informed Precision Dosing - MIPD): Begins with the same initial loading dose as the Standard Dosing arm, with subsequent doses adjusted based on a Bayesian forecasting model that integrates real-time PK and echocardiographic data.
RECRUITING
McMaster Children's Hospital - Neonatal Intensive Care Unit, Hamilton
McMaster University
OTHER
Hamilton Academic Health Sciences Organization
OTHER
Hamilton Health Sciences Corporation
OTHER