Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• Preterm infants born at 24-37 gestational age

• diagnosis of Hemodynamically significant patent ductus arteriosus

• Medical staff decided to treat with Ibuprofen

• Parents have signed informed consent

Exclusion Criteria:

• Contraindication for ibuprofen

• Alanine transaminase /Aspartate transaminase≥ 200 U/L

• Significant congenital heart disease