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Inotrope and Lusitrope

Milrinone for Congenital Diaphragmatic Hernia

Phase 2
Recruiting
Led By Satyan Lakshminrusimha, M.D.
Research Sponsored by NICHD Neonatal Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants must be ≥ 36 0/7 weeks PMA by best obstetric estimate AND have a birth weight of ≥ 2000g
Must be on invasive mechanical ventilation (defined as ventilation with an endotracheal tube)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after initiation of the study drug at 4 time points per day - every 6 hours x 72 hours or discontinuation of study drug (whichever comes first)
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of the drug milrinone in infants with congenital diaphragmatic hernia.

Who is the study for?
This trial is for newborns over 36 weeks gestation, weighing at least 2000g, diagnosed with congenital diaphragmatic hernia (CDH), experiencing severe lung and heart issues due to the hernia. They must be on mechanical ventilation but stable enough not to require certain emergency treatments or have specific heart conditions, bleeding in the brain, or genetic disorders that shorten life span.Check my eligibility
What is being tested?
The study tests Milrinone's safety and effectiveness in improving oxygen levels in infants with CDH compared to a placebo. Infants will be randomly assigned to receive either Milrinone or a placebo solution intravenously while their oxygenation status is monitored.See study design
What are the potential side effects?
Milrinone may cause changes in blood pressure or heart rhythm, headaches, nausea or vomiting. It can also potentially lead to an increased risk of infection due to its effects on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby was born at or after 36 weeks of pregnancy and weighed at least 2000g.
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I am on a breathing machine through a tube in my windpipe.
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My latest blood gas test shows PCO2 levels at or below 80 mmHg.
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My baby is 7 days old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after initiation of the study drug at 4 time points per day - every 6 hours x 72 hours or discontinuation of study drug (whichever comes first)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after initiation of the study drug at 4 time points per day - every 6 hours x 72 hours or discontinuation of study drug (whichever comes first) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oxygenation Response
Secondary outcome measures
Adjusted Oxygen Response
Oxygen
Changes in estimated systolic pulmonary arterial pressure on echocardiogram
+10 more

Side effects data

From 2017 Phase 2 trial • 72 Patients • NCT02232399
9%
Inotropic score > 20
9%
Junctional ectopic tachycardia
6%
Third-degree atrioventricular block
3%
Re-operation and dialysis post re-operation
3%
Enalapril caused prolonged hospitalisation
3%
hydrocephalus and seizure
3%
AV block III
3%
Readmission
3%
Upper respiratory tract infection
3%
Blood culture verified S. aureus sepsis
3%
Postoperative AV-block
3%
Fever and diarrea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levosimendan
Milrinone

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MilrinoneExperimental Treatment1 Intervention
Milrinone infusion at 0.33µg/kg/min. The dose of the study drug will be increased to 0.66 µg/kg/min if oxygenation index (OI) remains ≥ 10 without any evidence of hypotension (as defined by the protocol) two hours after initiation of study drug. Infusion will be continued until the OI decreases to < 7. The maximum duration of study drug infusion is 72 hours.
Group II: 5% dextrose (D5W)Placebo Group1 Intervention
An equivalent volume of 5% dextrose (D5W) will be used for infants randomized to the placebo arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Milrinone
2013
Completed Phase 4
~23000

Find a Location

Who is running the clinical trial?

NICHD Neonatal Research NetworkLead Sponsor
59 Previous Clinical Trials
205,704 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,977 Previous Clinical Trials
2,680,731 Total Patients Enrolled
Satyan Lakshminrusimha, M.D.Principal InvestigatorUniversity of California, Davis

Media Library

Milrinone (Inotrope and Lusitrope) Clinical Trial Eligibility Overview. Trial Name: NCT02951130 — Phase 2
Pulmonary Hypertension Research Study Groups: Milrinone, 5% dextrose (D5W)
Pulmonary Hypertension Clinical Trial 2023: Milrinone Highlights & Side Effects. Trial Name: NCT02951130 — Phase 2
Milrinone (Inotrope and Lusitrope) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02951130 — Phase 2
~9 spots leftby May 2025