Clinical Trial Details
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NCT03103022 : Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus
PhasePhase 1
AgesMin: 23 Weeks Max: 30 Weeks
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

8. Participation in another research trial
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