Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

Conditions

• Post-ligation Cardiac Syndrome

Eligibility Criteria

Sex

ALL

Age

N/A - 3 Months

Healthy Volunteers

Not accepted

Interventions

• Milrinone infusion — DRUG
  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).
• Placebo infusion — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jun 13, 2025

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2029

Study Design

Enrollment

316 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Placebo Comparator: Placebo
  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.
• Active Comparator: Milrinone
  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).

Primary Outcome Measure

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 ]

Central Contacts

• Patrick J McNamara
  319-467-7435
  [email protected]
• Valerie Chock
  650-723-5711
  [email protected]

Locations (19)

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