Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
ConditionPost-ligation Cardiac Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 3
SponsorNICHD Neonatal Research Network
About 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 does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Milrinone infusion
DrugAn 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
DrugAn 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.
Treatment groups
316 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: MilrinoneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure
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.
Time frame
Onset within 48 hours but may last up to 7 daysSecondary outcomes
1
Systemic hypotension
Either systolic blood pressure below the 3rd percentile for gestational age or mean blood pressure below the postmenstrual age equivalent
Time frame
Onset within 48 hours but may last up to 7 days2
Systemic hypertension
Systolic blood pressure above the 97th percentile
Time frame
Onset within 48 hours but may last up to 7 days3
Oxygenation failure
An absolute increase of at least 20% in the fraction of inspired oxygen or mean airway pressure compared with the one-hour post-intervention value that persists for a minimum of 1 hour and occurs within 72 hours of PDA closure
Time frame
Onset within 48 hours but may last up to 7 days4
Ventilation failure
Need for high frequency oscillatory ventilation when conventional ventilation strategies fail or a 20% rise in amplitude compared with the one-hour post-intervention value that persists for a minimum of 1 hour and occurs within 72 hours of PDA closure
Time frame
Within 72 hours of PDA closureSponsors and contacts
Click on the lead sponsor to view all of their trials.
NICHD Neonatal Research Network
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov