Paracetamol in Patent Ductus Arteriosus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02422966|
Recruitment Status : Recruiting
First Posted : April 22, 2015
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ductus Arteriosus, Patent||Drug: Paracetamol Drug: Ibuprofen||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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, Prospective Study|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Paracetamol intravenous solution 15 mg/kg (corresponding to 1.5 ml/kg) per dose every 6 hours for 3 days, for a total amount of 12 doses.
Other Name: Acetaminophen
Active Comparator: Ibuprofen
Ibuprofen intravenous solution at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 5 mg/kg at 48 h.
- success rate in closing PDA using paracetamol in comparison to ibuprofen. [ Time Frame: at Visit 3 (day 3). ]assessed echocardiographically.
- 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). ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422966
|Contact: Paola Lipone||003906910451 ext email@example.com|
|Contact: Alessandra Del Vecchio||003906910451 ext firstname.lastname@example.org|
|Azienda Ospedaliero Universitaria Careggi - Neonatologia e Terapia Intensiva Neonatale||Recruiting|
|Firenze, Italy, 50134|
|Contact: Carlo Dani, MD 00390557947792 email@example.com|
|Contact: Chiara Poggi, MD 00390557947792 firstname.lastname@example.org|
|Principal Investigator: Carlo Dani, MD|
|Sub-Investigator: Chiara Poggi, MD|
|IRCCS "Giannina Gaslini" Genova - Patologia Neonatale e Terapia Intensiva Neonatale||Active, not recruiting|
|Genova, Italy, 16147|
|Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico U.O. di Neonatologia e Terapia Intensiva Neonatale||Recruiting|
|Milano, Italy, 20122|
|Contact: Fabio Mosca, MD 00390255032907 email@example.com|
|Principal Investigator: Fabio Mosca, MD|
|Azienda Ospedaliera Istituti Clinici di Perfezionamento (ICP) - Ospedale dei Bambini "Vittore Buzzi" Milano - Neonatologia||Active, not recruiting|
|Milano, Italy, 20154|
|Policlinico Gemelli Roma - UOC Neonatologia||Recruiting|
|Roma, Italy, 00168|
|Contact: Costantino Romagnoli, MD 003906 30154786 firstname.lastname@example.org|
|Principal Investigator: Costantino Romagnoli, MD|