drugset / Trial / NCT06679855
Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
Phase 3
Recruiting
316 enrolled
NICHD Neonatal Research Network
National Heart, Lung, and Blood Institute (NHLBI) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.