NCT00440804

Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA

Randomized, Double-Blind Study of Ibuprofen L-Lysine Intravenous Solution in Premature Infants for the Early Treatment of Patent Ductus Arteriosus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Farmacon · Industry
• Sex: All
• Age: 28 Weeks – 34 Weeks
• Healthy volunteers: —

Summary

The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.

Detailed description

The ductus arteriosus remains patent in about 40% to 80% of very low birth weight infants. Early treatment by intravenous ibuprofen L-lysine (IV ibuprofen) has been suggested in preliminary studies to close the ductus and shorten hospital stay. This study aims to determine the effect of early treatment with IV ibuprofen given to the very low birth weight infant with a non-symptomatic patent ductus arteriosus (PDA) at less than 72 hours of life to accelerate and maintain ductal closure, thereby reducing the need for rescue therapy.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	ibuprofen l-lysine iv solution (NeoProfen (R) )

Timeline

• Start date: 2002-12-01
• Completion: 2005-08-01
• First posted: 2007-02-27
• Last updated: 2007-02-27