Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03103022 : Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus
PhasePhase 1
AgesMin: 23 Weeks Max: 30 Weeks
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03103022      |      Link to official Clinicaltrials.gov listing
Locations



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