Addition of Acetaminophen in Standard PDA Management

Patent Ductus Arteriosus Clinical Trial

Official title:

Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04026464
• Other study ID #: IRB201901829 -A
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2021
• Est. completion date: May 12, 2021

Study information

• Verified date: June 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 28 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• Intravenous Ibuprofen
The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently.
• Intravenous Ibuprofen + Oral Acetaminophen
The combined treatment group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently and will in addition receive 15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of infants with PDA closure.	Percentage of patients who demonstrated PDA closure.	During hospitalization, up to 10 days