Brief Title
Addition of Acetaminophen in Standard PDA Management
Official Title
Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial
Brief 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Percentage of infants with PDA closure.
Condition
Patent Ductus Arteriosus
Intervention
Intravenous Ibuprofen
Study Arms / Comparison Groups
Ibuprofen+Acetaminophen Group
Description: Infants with PDA randomized to the combined treatment group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) and oral acetaminophen (15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
230
Start Date
April 2021
Completion Date
March 2023
Primary Completion Date
March 2023
Eligibility 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
Gender
All
Ages
23 Weeks - 28 Weeks
Accepts Healthy Volunteers
No
Contacts
Sanket D Shah, MD, 904-202-4242, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04026464
Organization ID
IRB201901829 -A
Responsible Party
Sponsor
Study Sponsor
University of Florida
Study Sponsor
Sanket D Shah, MD, Principal Investigator, University of Florida
Verification Date
July 2020