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Compensation: Varies

Number of Visits: 1

Duration: 3-5 days

316 Participants Needed

Milrinone for Heart Function After Surgery
(MIDAS Trial)

Recruiting at 18 trial locations

Overseen ByPatrick J McNamara

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: NICHD Neonatal Research Network

Must not be taking: Vasodilators, Inodilators

Disqualifiers: Congenital malformation, Heart disease, others

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who are currently using vasodilator or inodilator agents. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Milrinone for improving heart function after surgery?

Research shows that Milrinone helps improve heart function in patients after heart surgery by increasing the cardiac index (a measure of heart performance) and reducing pressure in the heart. It also aids in separating patients from heart-lung machines during surgery and predicts recovery of heart function after surgery.¹ ² ³ ⁴ ⁵

Is milrinone safe for use in humans after heart surgery?

Milrinone is generally well tolerated in humans, but it may increase the risk of certain heart rhythm problems (arrhythmias) after heart surgery. It has been used safely in both adults and children, but monitoring for arrhythmias is important.¹ ² ⁴ ⁶ ⁷

How does the drug Milrinone differ from other treatments for improving heart function after surgery?

Milrinone is unique because it is a phosphodiesterase inhibitor that enhances heart muscle contraction and dilates blood vessels, improving heart function after surgery. Unlike some other treatments, it can be administered as a single dose or continuous infusion, and it does not cause significant changes in blood gas concentrations, making it a preferred option for managing low cardiac output states after heart surgery.² ⁴ ⁶ ⁸ ⁹

What is the purpose of this trial?

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; and2. to determine the effects of milrinone on two-year survival and neurodevelopmental outcome.

Eligibility Criteria

This trial is for infants who have undergone PDA closure, a heart procedure. It's designed to see if milrinone can help their hearts supply oxygen better post-surgery. Infants with specific conditions like Postpericardiotomy syndrome, Klinefelter Syndrome, and Triple X Syndrome are included.

Inclusion Criteria

Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention

My baby was born at or before 27 weeks and 6 days and is younger than 3 months.

I use a machine to help with my breathing, but not just a simple nose tube.

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Exclusion Criteria

Any major congenital malformation

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

I do not have significant congenital heart disease, except for very small defects.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants receive either milrinone or placebo after PDA closure, with close monitoring and dose adjustments based on response

3-5 days

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up visit at 2 years of age to assess neurodevelopmental outcomes

22 to 26 months

1 visit (in-person) at 2 years of age

Post-treatment Monitoring

Monitoring for post-ligation cardiac syndrome or death within 7 days of PDA closure

7 days

Treatment Details

Interventions

Milrinone

Trial Overview The study compares the effects of milrinone infusion versus a placebo on infant heart function after PDA closure surgery. The main focus is whether milrinone reduces death or PLCS risk within 7 days and its impact on two-year survival and neurodevelopment.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: MilrinoneActive Control1 Intervention

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).

Group II: PlaceboPlacebo Group1 Intervention

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.

Milrinone is already approved in United States, Canada, European Union for the following indications: