Expired Study
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Lousiville, Kentucky 40202


Purpose:

The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated with these medications. The medications being used for PDA closure are indomethacin and neoprofen.


Study summary:

All babies requiring medical treatment of their PDA will receive up to 3 doses of medication. For babies enrolled in the control group of this study, she/he will not be treated with either of these medicines.


Criteria:

Inclusion Criteria: - Less than or equal to 32 weeks gestation; - Less than or equal to 1250 g; - Mechanical ventilation; - Echocardiographic findings of PDA with left to right shunting; - Medical judgement of neonatologist for medical treatment; Exclusion Criteria: - Urine output less than 1 ml/k/hr over previous 12 hours; - Serum creatinine greater than 1.5 mg/dL; - Platelet count less than 100,000 per cubic mm; - Significant skin breakdown at sensor areas; - Significant congenital anomalies - Intraventricular hemorrhage greater than or equal to grade III


NCT ID:

NCT00554307


Primary Contact:

Principal Investigator
Dan L Stewart, MD
University of Louisville


Backup Contact:

N/A


Location Contact:

Lousiville, Kentucky 40202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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