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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
If an arterial blood gas is not available at the time of randomization, a preductal OSI of ≥ 5 can be used as an inclusion criterion instead of OI ≥ 10 (the OSI should be based on the most recent preductal pulse oximetry recording and must be within 12 hours of randomization)
Infants must be ≥ 36 0/7 weeks PMA by best obstetric estimate AND have a birth weight of ≥ 2000g
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 oxygen saturation index is at least 5, based on the latest test within 12 hours.
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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%
Enalapril caused prolonged hospitalisation
3%
Fever and diarrea
3%
Upper respiratory tract infection
3%
AV block III
3%
Blood culture verified S. aureus sepsis
3%
Postoperative AV-block
3%
hydrocephalus and seizure
3%
Readmission
3%
Re-operation and dialysis post re-operation
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
1,953 Previous Clinical Trials
2,660,414 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other scientific investigations that have used Milrinone before?

"At the moment, there are 15 clinical trials underway that are studying Milrinone. 3 of those trials are in their final phase. Most of the trials for Milrinone are taking place in Bangkok and Songkhla, but there are 229 locations running these studies altogether."

Answered by AI

What is the regulatory status of Milrinone in the United States?

"Milrinone's safety is rated a 2 because, while there is some evidence suggesting it is safe, none of the clinical data collected thus far supports its efficacy."

Answered by AI

How many test subjects are participating in this experiment?

"Sixty-six patients who meet the prerequisites are needed to carry out this experiment. Those who take part can do so from different hospitals, such as University of Rochester in Rochester, New york and Emory University in Atlanta, Georgia."

Answered by AI

Are adolescents eligible for this particular research study?

"This research is enrolling individuals who are 168 hours old or younger."

Answered by AI

In how many different places can patients enroll in this study?

"There are 15 enrolling patients for this study at sites including University of Rochester in Rochester, Emory University in Atlanta, and Case Western Reserve University, Rainbow Babies and Children's Hospital in Cleveland."

Answered by AI

What are some of the chief benefits of Milrinone?

"while commonly used as a diarrhea treatment, Milrinone can also help with other conditions like end stage chronic kidney failure, fluid replacement therapy, and hemodialysis."

Answered by AI

Are new patients being enrolled in this clinical trial at this time?

"This study, which is currently looking for participants, was originally posted on 8/22/2017. The listing was last edited on 10/27/2021 according to the data available on clinicaltrials.gov"

Answered by AI

Might I be eligible to take part in this research?

"This trial is recruiting 66 participants, between the ages of 0 Hours and 168 Hours who have morgagni hernias. It is required that participants also meet the following criteria: postnatal age ≤7 days (168 hours of age), invasive mechanical ventilation (defined as ventilation with an endotracheal tube), one arterial blood gas with an OI ≥ 10 (after tracheal tube obstruction and other easily resolvable mechanical causes for increased OI are ruled out) on the most recent arterial blood gas within 12 hours prior to the time of randomization., if an arterial blood gas is not available"

Answered by AI

Who else is applying?

What site did they apply to?
University of Texas Southwestern Medical Center at Dallas
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
~0 spots leftby Mar 2024