Acetaminophen vs Indomethacin in Treating hsPDA

Stopped early · Phase 3

Conditions studied: Patent Ductus Arteriosus

In brief

The purpose of this study is to see if acetaminophen (Tylenol) is as effective as indomethacin in closing patent ductus arteriosus in premature infants.

Key facts

Study ID

NCT03537144

Run by

University of Tennessee

People needed

37

Starts

2016-06-01

Expected to finish

2018-09-01

Last updated by the study team

2019-12-03

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age at birth 22 weeks to 31 6/7 weeks.
• Birth weight ≤ 1500 grams
• Day of life ≤ 21 days
• ECHO findings:
• Left-to-right ductal flow AND 2 of the following 3:
• Ductal size > 1.5mm at smallest diameter
• Reversal of flow in descending aorta
• Left atrial size to aortic root ratio >1.5
• Platelet count > 50,000

You may not qualify if…

• Ductal dependent congenital heart disease
• Major congenital anomaly
• Life-threatening infection
• Urine output < 1cc/kg/hr in prior 8 hours
• Serum creatinine > 1.8 mg/dL
• Hyperbilirubinemia requiring exchange transfusion
• Active NEC Stage 2 or 3 using Bell's staging criteria
• Active intestinal perforation
• Liver dysfunction [2x upper limit of normal for aspartate aminotransferase(AST) and/or alanine aminotransferase (ALT)]
• Active GI bleeding
• Concurrent hydrocortisone use
• Known IVH Grade 3 or 4

Where it is running

• LeBonheur Children's Hospital — Memphis, Tennessee, United States
• Methodist-Lebonheur Germantown Hospital — Memphis, Tennessee, United States
• Regional One Health — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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