Milrinone for Heart Function After Surgery

(MIDAS Trial)

Recruiting at 18 trial locations

Overseen By Patrick J McNamara

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NICHD Neonatal Research Network

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

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; and 2. 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.

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.

Treatment Details

Interventions

• Milrinone (Phosphodiesterase Inhibitor)

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

Group I: Milrinone Active Control 1 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: Placebo Placebo Group 1 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 Canada for the following indications:

Approved in Canada as Milrinone for:

• Acute heart failure
• Cardiogenic shock

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials

62

Recruited

209,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+