Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in
preterm infants, especially in those born at a gestational age <28 weeks and/or a birth
weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has
been associated with serious complications. However, a common finding is that medical and/or
surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity.
This might be related to the fact that a substantial portion of preterm infants are treated
unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without any
specific intervention. An expectative approach is gaining interest, although convincing
evidence is still missing.
The objective of this study is to investigate whether in preterm infants <28 weeks' gestation
with a PDA an expectative management is not inferior to early treatment with regard to the
composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary
dysplasia (BPD) at a postmenstrual age of 36 weeks.