NCT06679855 Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
| NCT ID | NCT06679855 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | NICHD Neonatal Research Network |
| Condition | Post-ligation Cardiac Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2025-06-13 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 316 participants in total. It began in 2025-06-13 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Gestational age at birth ≤27 weeks (and 6 days) and postnatal age \< 3 months at intervention * Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula) * Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention * Decision by clinical team to proceed with PDA closure via surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features of hemodynamic significance. Exclusion Criteria: * Any major congenital malformation * Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (\<3mm) atrial septal defect) * Acute renal failure defined by urine output \< 0.5 mL/kg/hour OR rise of serum creatinine by 0.3 mg/dL within 48 hours OR rise of serum creatinine more than 40% above baseline serum creatinine within prior 72 hours. * Systemic administration of vasodilator/inodilator agents * Prior history of arrhythmia
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06679855 clinical trial?
This trial is open to participants of all sexes, up to 3 Months, studying Post-ligation Cardiac Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06679855 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 316 participants.
Is NCT06679855 currently recruiting?
Yes, NCT06679855 is actively recruiting participants. Contact the research team at patrick-mcnamara@uiowa.edu for enrollment information.
Where is the NCT06679855 trial being conducted?
This trial is being conducted at Birmingham, United States, Orange, United States, Palo Alto, United States, San Diego, United States and 11 additional locations.
Who is sponsoring the NCT06679855 clinical trial?
NCT06679855 is sponsored by NICHD Neonatal Research Network. The trial plans to enroll 316 participants.