drugset / Trial / NCT06679855

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

NCT06679855

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The goal of this Phase 3, randomized, masked clinical trial is to is to find out whether milrinone, when given to infants after PDA closure, will help the heart work better by supplying oxygen to the lungs and tissues. The main questions it aims to answer are: 1. to determine if milrinone decreases the risk of death or PLCS within 7 days of the procedure, compared to standard treatment; and 2. to determine the effects of milrinone on two-year survival and neurodevelopmental outcome.

Timeline

Start
2025-06-13
Primary completion
2027-06-30
Completion
2029-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Milrinone Small molecule 0.33 ug/kg Intravenous
Comparator Milrinone Small molecule 0.66 ug/kg Intravenous
Comparator Milrinone Small molecule 0.75 ug/kg Intravenous

Indications

No indication recorded.