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 as good as an early treatment with regard to the composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary dysplasia (BPD).
This is a multicenter, randomized study that will be conducted in neonatal intensive care units.
Randomization will assign the neonate to either the medical treatment (ibuprofen) arm, in which the intention is to close the DA, or the expectative PDA management arm, in which the DA is considered to be an ‘innocent bystander’.
Infants are followed up till the age of 24 months in this trial.
| Summary of results |
|---|
Treatment of premature infants in whom the blood vessel that supplies oxygen to the body before birth does not immediately close by itself is not routinely required. Waiting for this blood vessel, the ductus, to close by itself is just as safe, the results of this study show. |
| Title |
Multi-center, randomized non-inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants. (KCE-16013) |
|
Participants (P) |
Preterm infants (GA<28 weeks) with an echocardiographic confirmed PDA with a transductal diameter >1.5 mm |
|
Intervention (I) |
Expectative PDA management is characterized as ‘watchful waiting’. No intervention is initiated with the intention to close a PD. |
|
Control (C) |
The preterm infants with a PDA are treated with COX-inhibition by Ibuprofen |
|
Outcome (O) |
The primary outcome is the composite of mortality, and/or NEC (Bell stage ≥ IIa), and/or BPD, defined as the need for supplemental oxygen need, all at a postmenstrual age of 36 completed weeks. |
|
Trial Design |
Multicenter, randomized, non-inferiority study conducted in neonatal intensive care units (NICU’s) in the Netherlands and Belgium |
|
Sample Size |
564 (150 in BE) |
|
Trial duration |
48 Months |
|
Budget |
€ 200 000 (incl. VAT) |
|
Sponsor |
Radboudumc Amalia Children’s Hospital |
|
Chief Investigator |
Willem P. de Boode, MD PhD Radboudumc Amalia Children’s Hospital Department of Pediatrics, Division of Neonatology Geert Grooteplein Zuid 10 6525 GA Nijmegen The Netherlands |
|
Belgian Coordinating Centre |
Antoine Mulders, UZA |
| Protocol | Download protocol |
| Results | View publication NEJM Watch video with summary of results (ENG) |
| Extra info | View study website |
For timelines and recruitment, see dashboard
Commissioning workstream 2016
