Addition of Acetaminophen in Standard PDA Management

• Status: Withdrawn
• Trial end date: 2021-05-12
• Target enrollment: 0
• Participant gender: All

Summary

Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.

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

Details

• Lead Sponsor: University of Florida
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight < 1000 grams

• Hemodynamically significant PDA as defined by any of the following:

1. Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA

2. Hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below the infants' post menstrual age)

3. Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)

• Echocardiographic criteria:

1. Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery > 0.5

Exclusion Criteria:

• No enteral feedings

• PDA-dependent congenital heart disease

• Prior treatment with prophylactic indomethacin

• Prior PDA treatment with any medications

• Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation

• Abnormal liver enzymes (ALT > 60 IU/L and AST > 60 IU/L)

• Platelets count < 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding

• Major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect

• Prior enrollment to other interventional clinical study where PDA is an outcome variable