Early Treatment Versus Expectative Management of PDA in Preterm Infants

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Cyclooxygenase Inhibitors; Ibuprofen; Indomethacin

Criteria

Inclusion Criteria:

• PDA diameter > 1.5 mm and ductal (predominantly) left-to-right shunt

• Signed informed consent obtained from parent(s) or representative(s)

• Gestational age < 28 completed weeks

Exclusion Criteria:

• Contraindication for administration of cyclooxygenase-inhibitors (COXi)

• Persistent pulmonary hypertension (ductal right-to-left shunt ≧33% of cardiac cycle)

• Congenital heart defect, other than PDA and/or patent foramen ovale (PFO)

• Life-threatening congenital defects

• Chromosomal abnormalities and/or congenital anomalies associated with abnormal neurodevelopmental outcome

• Use of COXi prior to randomization