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Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial

NCT06679855 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Post-ligation Cardiac Syndrome

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • NICHD Neonatal Research Network

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2027-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06679855 on ClinicalTrials.gov