NCT04026464

Addition of Acetaminophen in Standard PDA Management

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 23 Weeks – 28 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Intravenous Ibuprofen	The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently.
DRUG	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.

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-05-12
• Completion: 2021-05-12
• First posted: 2019-07-19
• Last updated: 2021-06-24

Regulatory

• FDA-regulated drug study