Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus
Status:
Recruiting
Trial end date:
2022-02-28
Target enrollment:
Participant gender:
Summary
Multicentric, double-blind clinical trial, which will evaluate the efficacy of iv paracetamol
versus standard treatment with ibuprofen in the closure of patent ductus arteriosus in the
preterm newborn. Secondarily, we intend to compare the safety of both treatments, increase
our knowledge about the pharmacokinetics, pharmacodynamics and pharmacogenetics of
paracetamol and ibuprofen in the neonatal period and make a pharmacoeconomic assessment of
the use of both drugs.
Phase:
Phase 3
Details
Lead Sponsor:
Máximo Vento Torres
Collaborators:
Instituto de Investigacion Sanitaria La Fe Spanish Clinical Research Network - CAIBER Spanish Clinical Research Network - SCReN