Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus
Status:
Completed
Trial end date:
2019-04-30
Target enrollment:
Participant gender:
Summary
Patent ductus arteriosus or PDA is a blood vessel that connects the right and left side of
the heart that usually closes after birth but remains open in some premature infants born
before 30 weeks' gestation. When this blood vessel remains open for a long time, it may cause
problems such as bleeding in the lung and brain, lung injury due to prolonged need of
ventilator, and poor kidney function. It sometimes becomes necessary to close this blood
vessel in the preterm infant. Currently, this blood vessel can be closed either by medication
or surgery. Pain medications such as Ibuprofen and Indomethacin are routinely used
medications to close PDA. However, in the last 5 year, acetaminophen has been found as an
alternative medication to close PDA in preterm infants. In multiple studies, acetaminophen is
found to be a safe alternative medication with lower side effects than current standard
management. Intravenous Ibuprofen is approved by FDA to treat PDA in preterm infants.
Although not approved by FDA, oral ibuprofen is being used for the management of PDA.
However, the success rate of a single medication is approximately 70%. Both medications have
been used in the previous clinical studies to treat the same condition in the preterm infants
and fewer side effects were reported. Mechanism of both medications to close PDA is different
and may work more effectively together than single medication alone. In this study, the
investigator are going to use these two medications (Ibuprofen and Acetaminophen) at the same
time if the child needs treatment and is eligible to participate in this study. This study is
based on the assumption that by using both medications at the same time, investigator can
close this blood vessel more effectively than with either drug alone.