Paracetamol in Patent Ductus Arteriosus

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Ductus Arteriosus, Patent

Clinical Trial Details

NCT number	NCT02422966
Study type	Interventional
Source	Aziende Chimiche Riunite Angelini Francesco S.p.A
Contact
Status	Completed
Phase	Phase 2
Start date	December 2015
Completion date	April 2019

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT03604796` - Alternative Paracetamol Treatments for the Neonate With a hsPDA	Phase 2/Phase 3
Completed	`NCT00000494` - Management of Patent Ductus in Premature Infants	Phase 3
Completed	`NCT01251939` - Changes in Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious	N/A
Completed	`NCT01031316` - Patent Ductus Arteriosus (PDA) Screening Trial	N/A
Completed	`NCT00828334` - NIT-OCCLUD PDA Phase II Sentinel Trial	N/A
Completed	`NCT00009646` - Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)	Phase 3
Withdrawn	`NCT00470743` - Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies	Phase 4
Completed	`NCT00725647` - Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies	N/A
Terminated	`NCT00239512` - New Management Strategy of PDA for VLBW Preterm Infants	N/A
Recruiting	`NCT04508036` - Ductus Arteriosus Closure and D-Dimer and Fibrinogen Levels
Completed	`NCT01243996` - High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant	Phase 2/Phase 3
Completed	`NCT00005190` - Reproduction and Survival After Cardiac Defect Repair	N/A
Not yet recruiting	`NCT04205877` - The U.S. PDA Registry
Recruiting	`NCT05547165` - Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants	N/A
Completed	`NCT02803671` - Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data	N/A
Completed	`NCT00799123` - Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants	N/A
Completed	`NCT00528736` - Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks	N/A
Completed	`NCT02002741` - Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants	Phase 2/Phase 3