Respiratory Distress Syndrome Clinical Trial
Official title:
Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus Closure in Preterm Infants. A Prospective, Randomized, Controlled, Double Blind, Multicenter Clinical Trial.
Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA. Aim of this randomized double-blind controlled study is to compare the efficacy and the safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps ameliorating the safety profile of the pharmacological treatment.
The objective of this trial is to compare the efficacy and safety of 2 therapeutic regimens
for PDA treatment in a population of preterm newborns of gestational age (GA) <31+6 weeks
with respiratory distress syndrome (RDS) and HsPDA:
- Group A: experimental boluses of paracetamol at 15 mg/Kg four time a day for three
consecutive days.
- Group B: standard boluses of ibuprofen at 10-5-5-mg/Kg/dose once a day for three
consecutive days.
The primary objective of the study is: to evaluate the efficacy of paracetamol versus
standard ibuprofen regimen, by comparing the rate of ductal closure after the first and
second course of pharmacological treatment. (PDA diagnosed by ECHO criteria)
The secondary objective of the study is: to evaluate the safety of the above 2 therapeutic
regimens in term of incidence of transient renal impairment, intraventricular hemorrhage
(IVH) or other bleeding disorders, necrotizing enterocolitis (NEC) and isolated bowel
perforation (without signs of NEC), incidence of sign of liver toxicity.
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