Study of Combined Acetaminophen and Ibuprofen Treatment for Patent Ductus Arteriosus in Extremely Premature Infants

What this Trial Is About

Researchers are studying the treatment of patent ductus arteriosus PDA, a common heart complication in extremely premature infants born before 27 weeks gestation. The study aims to compare the effects, safety, and clinical outcomes of a combination therapy using ibuprofen plus intravenous acetaminophen versus ibuprofen alone, the current standard treatment. This Phase 2 trial also evaluates neurodevelopmental outcomes at 18 to 30 months corrected age to understand the long-term impact of the treatments. Participants will receive either standard ibuprofen dosing, given intravenously or enterally and adjusted by age, combined with intravenous acetaminophen administered every six hours for three days, or standard ibuprofen with a placebo saline injection on the same schedule. The dosing of ibuprofen typically involves a higher initial dose on day one, followed by lower daily doses on days two and three. The study is randomized and triple-blinded to compare these two groups effectively. During the trial, infants will be closely monitored for outcomes such as mortality before discharge, bronchopulmonary dysplasia severity, treatment success, kidney and liver function, and the need for further PDA treatment or procedures. Researchers will also track respiratory support duration, use of medications like diuretics and steroids, incidence of sepsis, and other complications up to 250 days after randomization. The trial spans from initial treatment through hospital discharge or transfer, with long-term neurodevelopmental assessments planned.

Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants