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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial

Brief 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.

Detailed Summary: Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.
Sponsor: Rambam Health Care Campus

Current Primary Outcome: The incidence of patent ductus arteriosus closure [ Time Frame: 3-10 days after first dose of Ibuprofen + study drug ]

Original Primary Outcome:

• The incidence of patent ductus arteriosus closure [ Time Frame: 3-10 days after first dose of Ibuprofen + study drug ]
  By echocardiography
• The need for surgical ligation for PDA [ Time Frame: 3-21 days after first dose of Ibuprofen + study drug ]

Current Secondary Outcome:

• Adverse effects [ Time Frame: until discharge home (usually within 2-3 months since recruitment) ]
  Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records
• The need for surgical ligation for PDA [ Time Frame: 3-21 days after first dose of Ibuprofen + study drug ]
  need for surgical ligation for PDA

Original Secondary Outcome: Adverse effects [ Time Frame: until discharge home (usually within 2-3 months since recruitment) ]

Information By: Rambam Health Care Campus

Dates:
Date Received: November 24, 2013
Date Started: August 1, 2014
Date Completion: December 31, 2017
Last Updated: March 13, 2017
Last Verified: March 2017