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

• Status: Terminated
• Trial end date: 2020-12-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Alabama
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

1. Preterm infant ≤27 6/7

2. Written parental consent is obtained

3. Infant requires respiratory support

4. diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at least two of the following:

1. Ductus size ≥ 1.5 mm

2. Maximum flow velocity through the ductus ≤ 2 m/s

3. Left atrium to aorta ratio ≥ 1.4

4. Wide pulse pressure

5. B-type natriuretic peptide (BNP)

5. Attending neonatologist made decision to treat patent ductus arteriosus

Exclusion Criteria:

1. No parental consent

2. Infants > 21days of postnatal age

3. Congenital anomalies such as cardiac or multiple anomalies

4. Infection (e.g., septicemia, pneumonia)

5. Bleeding disorder or platelet count< 50,000/ml

6. Acute kidney injury (AKI)defined as oliguria (urine output< 0.5 ml/kg/hr for 16hrs) and/or serum creatinine > 1.5 mg/dl

7. Elevated liver enzymes (>2 fold from upper normal limits)

8. Pulmonary hypertension or right to left shunt through the ductus arteriosus

9. Diagnosis of necrotizing enterocolitis

10. Unable to tolerate oral medications at the time of enrollment.