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Milrinone in Congenital Diaphragmatic Hernia (CDH) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out whether a drug called Milrinone, when given to infants with CDH, will help the heart work better by supplying oxygen to the lungs and tissue.
What is the Condition Being Studied?
Congenital Diaphragmatic Hernia (CDH)

Who Can Participate in the Study?

Infant who: 
- Are ages 36 0/7 weeks old or older
- Have CDH (Congential Diaphragmatic Hernia).  
- Weigh at least 2000g (about 4 pounds)

Age Group
Children

What is Involved?

If you decide that you would like for your child to be part of this study, your child will:
- Be randomly given (like flipping a coin) either the study medicine, Milrinone or a sugar solution, placebo.
- Be given the study medicine for up to 3 days only.
- May have up to two head ultrasounds.
-- One head ultrasound will be completed before study medication begins.
-- One ultrasound when study medication is complete.
- Complete 3 questionnaires at 4, 8, and 12 months of age regarding the infant's health. 

Study Details

Full Title
A Phase II Pilot Trial on Milrinone in Congenital Diaphragmatic Hernia
Principal Investigator
Protocol Number
IRB: PRO00084506
NCT: NCT02951130
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698