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More info
You can access this
clinical trial
if you have
Patent Ductus Arteriosus
and you are
under 3
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Drug: Ibuprofen
  • Other: Expectative Management
  • Drug: Indomethacin
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Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02884219. The sponsor of the trial is Radboud University and it is looking for 564 volunteers for the current phase.
Official trial title:
Multi-center, Randomized Non-inferiority Trial of Early Treatment Versus Expectative Management of Patent Ductus Arteriosus in Preterm Infants (BeNeDuctus Trial - Belgium Netherlands Ductus Trial)