Clinical Trial: Paracetamol in Patent Ductus Arteriosus

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

Official Title: Efficacy and Safety of Paracetamol in Comparison to Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants: A Randomized, Open Label, Comparator-controlled, P

Brief Summary: The purpose of the study is to assess the efficacy and safety of paracetamol in comparison to ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.

Detailed Summary:

Although patency of the ductus arteriosus is essential for fetal circulation, the postnatal ductal closure is critical for postnatal circulatory adaptation. In premature infants the circulating prostaglandin levels are higher than at term, and respiratory difficulties may lead to a state of hypoxia, which contribute to the failure of the ductus closure. Recently, an incidental finding in one preterm infant led to look at paracetamol, one of the most common drugs available, as an alternative therapeutic approach to ductal closure. If paracetamol is proven to be effective, it could become the treatment of choice for the management of PDA, mainly due to its more favorable safety profile.

Although the recent results available in the literature demonstrates an highly success rate in ductal closure with paracetamol, all case studies are not powered to show efficacy of paracetamol for PDA closure. Further prospective randomized-controlled trials are needed to evaluate the efficacy of paracetamol versus ibuprofen for the closure of PDA.

If paracetamol is indeed proven to be effective, it could become the treatment of choice for the management of PDA, mainly due to its more favorable side effect profile. In order to test this hypothesis, a randomized, open label, parallel groups, comparator controlled, multicentre, prospective study is proposed.


Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

Current Primary Outcome: success rate in closing PDA using paracetamol in comparison to ibuprofen. [ Time Frame: at Visit 3 (day 3). ]

assessed echocardiographically.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • number of re-openings. [ Time Frame: at Follow-up 3 (day 30). ]
    assessed echocardiographically.
  • success rate in closing PDA after the second treatment course of ibuprofen as rescue medication. [ Time Frame: at Visit 6 (day 6). ]
    assessed echocardiographically.
  • success rate of closing PDA after the first day of the first treatment course. [ Time Frame: at Visit 1 (day 1). ]
    assessed echocardiographically.
  • success rate of closing PDA after the second day of the first treatment course. [ Time Frame: at Visit 2 (day 2). ]
    assessed echocardiographically.
  • incidence of surgical ligation. [ Time Frame: at Follow-up 3 (day 30). ]
  • incidence of renal failure, liver failure and gastrointestinal complications (including isolated intestinal perforation). [ Time Frame: at Follow-up 3 (day 30). ]
    assessed by laboratory analysis.
  • incidence of death, [ Time Frame: at Follow-up 3 (day 30). ]
  • incidence of death. [ Time Frame: at Follow-up 4 (40 weeks post-conception). ]
  • incidence of sepsis. [ Time Frame: at Follow-up 3 (day 30). ]
  • hospital-stay duration in Neonatal Intensive Care Unit. [ Time Frame: at Follow-up 4 (40 weeks post-conception). ]
  • occurrence of adverse effects. [ Time Frame: at Follow-up 3 (day 30). ]


Original Secondary Outcome: Same as current

Information By: Aziende Chimiche Riunite Angelini Francesco S.p.A

Dates:
Date Received: April 9, 2015
Date Started: December 2015
Date Completion: March 2018
Last Updated: September 7, 2016
Last Verified: September 2016