NCT06679855 · NICHD Neonatal Research Network
Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
(MIDAS)
What this study is about
The goal of this Phase 3, randomly assigned, 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.
View original scientific description
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.
Interventions
DRUG
Milrinone infusion
An intravenous (iv) infusion of milrinone will be administered at an initial dose of 0.33 mcg/kg/min and accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes).
DRUG
Placebo infusion
An iv infusion of placebo (0.9% saline) of equivalent volume will be administered. The infusion will be accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes) to ensure blinding is maintained.
Primary outcome measures
Post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure
Time frame: Onset within 48 hours but may last up to 7 days
Composite outcome of post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure. Onset within 48 hours but may last up to 7 days.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Orange, California
- Palo Alto, California
- San Diego, California
- Atlanta, Georgia
- Chicago, Illinois
- Iowa City, Iowa
- Boston, Massachusetts
- Jackson, Mississippi
- Albuquerque, New Mexico
- Durham, North Carolina
- Cincinnati, Ohio
And 7 more locations — see the full list below.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations