Early Treatment Versus Expectant Management of PDA in Preterm Infants
Status:
Completed
Trial end date:
2021-07-20
Target enrollment:
Participant gender:
Summary
Patent ductus arteriosus (PDA) in very preterm newborns is associated with severe neonatal
mor-bidity: intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing
en-terocolitis (NEC), retinopathy of prematurity (ROP). Existing methods of management PDA do
not reduce the incidence of these diseases. The efficacy of cyclooxygenase inhibitors (COX)
which are currently the standard of treatment in extreme preterm infants is about 70-80%. COX
inhibitors have significant side effects. On the other hand, surgical ligation of the ductus
arteriosus is associated with deterioration due to cardio-pulmonary problems and long-term
complications. Paracetamol has been proposed for treatment of hemodynamically significant PDA
because it has a different mecha-nism of action compared with COX inhibitors and a better
safety profile.
Recently, expectant approach has becoming more popular, although there is not enough evidence
to support it.
The objective of this study is to investigate whether in preterm infants, born at a GA less
than 32 weeks, with a PDA (diameter > 1.5 mm) at a postnatal age of < 72 h, an expectant
management is non-inferior to early treatment with regard to the composite of mortality
and/or severe morbidity.