Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Patent Ductus Arteriosus, Preterm Infant, Bronchopulmonary Dysplasia

In brief

The purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and oral acetaminophen has higher success rate in closing the ductus arteriosus than a standard treatment strategy of using intravenous ibuprofen alone among preterm infants.

Key facts

Study ID

NCT03701074

Run by

University of South Alabama

People needed

1

Starts

2018-12-15

Expected to finish

2020-12-02

Last updated by the study team

2026-04-30

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Preterm infant ≤27 6/7
• Written parental consent is obtained
• Infant requires respiratory support
• diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at least two of the following:
• Ductus size ≥ 1.5 mm
• Maximum flow velocity through the ductus ≤ 2 m/s
• Left atrium to aorta ratio ≥ 1.4
• Wide pulse pressure
• B-type natriuretic peptide (BNP)
• Attending neonatologist made decision to treat patent ductus arteriosus

You may not qualify if…

• No parental consent
• Infants > 21days of postnatal age
• Congenital anomalies such as cardiac or multiple anomalies
• Infection (e.g., septicemia, pneumonia)
• Bleeding disorder or platelet count< 50,000/ml
• Acute kidney injury (AKI)defined as oliguria (urine output< 0.5 ml/kg/hr for 16hrs) and/or serum creatinine > 1.5 mg/dl
• Elevated liver enzymes (>2 fold from upper normal limits)
• Pulmonary hypertension or right to left shunt through the ductus arteriosus
• Diagnosis of necrotizing enterocolitis
• Unable to tolerate oral medications at the time of enrollment.

Where it is running

• University of South Alabama — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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