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Milrinone for Congenital Diaphragmatic Hernia
Study Summary
This trial is testing the safety and effectiveness of the drug milrinone in infants with congenital diaphragmatic hernia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 2 trial • 72 Patients • NCT02232399Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Milrinone
- Group 2: 5% dextrose (D5W)
- 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.
Frequently Asked Questions
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."
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."
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."
Are adolescents eligible for this particular research study?
"This research is enrolling individuals who are 168 hours old or younger."
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."
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."
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"
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"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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