Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus

• Status: Completed
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

1. Infant with gestational age 23 to 30 weeks at birth and birth weight between 500 - 1000 grams

2. Postnatal age less than equal to 14 days

3. Hemodynamically significant PDA as defined by any of the following:

1. Increased ventilator support attributed by the clinician to be due to PDA

2. Hypotension and/or widening pulse pressure requiring vasopressors

3. Signs of congestive heart failure such as pulmonary congestion

4. Echocardiographic criteria:

1. Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery > 0.5

Exclusion Criteria:

1. PDA-dependent congenital heart disease

2. Prior treatment with prophylactic indomethacin

3. Significant hyperbilirubinemia requiring exchange transfusion

4. Active or suspected necrotizing enterocolitis (NEC) and/or intestinal perforation

5. Abnormal liver enzymes

6. Platelets count < 50000 /l and / or active intracranial or gastrointestinal bleeding or from any other site

7. Major congenital anomalies such as neural tube defect, chromosomal abnormality and gastrointestinal defect