Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT

PHASE2RecruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

July 4, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2027

Conditions
Patent Ductus ArteriosusPreterm
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

L8N 3Z2

RECRUITING

McMaster Children's Hospital - Neonatal Intensive Care Unit, Hamilton

All Listed Sponsors
collaborator

McMaster University

OTHER

collaborator

Hamilton Academic Health Sciences Organization

OTHER

lead

Hamilton Health Sciences Corporation

OTHER