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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 belowSelect...
My baby was born at or after 36 weeks of pregnancy and weighed at least 2000g.
Select...
I am on a breathing machine through a tube in my windpipe.
Select...
My latest blood gas test shows PCO2 levels at or below 80 mmHg.
Select...
My baby is 7 days old or younger.
Timeline
Screening ~ 3 weeks3 visits
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)
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)
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 moreSide effects data
From 2017 Phase 2 trial • 72 Patients • NCT022323999%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a breathing machine through a tube in my windpipe.My infant is on special medication for lung blood vessel issues or is on ECMO.Your recent blood test shows that your blood is getting enough oxygen.My oxygen saturation index is at least 5, based on the latest test within 12 hours.My infant has a specific type of heart defect present from birth.My infant has a birth defect in both sides of the diaphragm.My infant has a birth defect involving the throat or food pipe.My infant has kidney issues not caused by maternal factors, or severe low amniotic fluid due to kidney problems.My infant has had very low blood pressure for at least 2 hours despite strong medication.My infant has a blood clotting issue not improved by blood products.My infant has high CO2 levels despite maximum support from a ventilator.My baby was born at or after 36 weeks of pregnancy and weighed at least 2000g.My latest blood gas test shows PCO2 levels at or below 80 mmHg.My infant has low platelet counts despite receiving blood products.My infant has a genetic condition known to shorten life span.My infant has been diagnosed with thickened heart muscles.My infant is receiving comfort care instead of full treatment.My infant has had a brain bleed confirmed by ultrasound.Infants whose doctors have said they cannot be in the trial.My baby is 7 days old or younger.My infant is not enrolled in any other clinical trials for lung treatments.My infant is on milrinone treatment before being assigned to a study group.
Research Study Groups:
This trial has the following groups:- Group 1: Milrinone
- Group 2: 5% dextrose (D5W)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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