NCT03860428

Early Treatment Versus Expectant Management of PDA in Preterm Infants

Randomized Non-inferiority Trial of Early Treatment Versus Expectant Management of Patent Ductus Arteriosus in Preterm Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Lviv National Medical University · Academic / Other
• Sex: All
• Age: 3 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Ibuprofen	In the medical treatment arm the in-tention is to close the ductus arteriosus.
DRUG	Paracetamol	In the medical treatment arm the in-tention is to close the ductus arteriosus.
OTHER	Expectant Management	Expectative PDA management is character-ized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA.

Timeline

• Start date: 2019-02-15
• Primary completion: 2021-07-20
• Completion: 2021-07-20
• First posted: 2019-03-04
• Last updated: 2022-04-13

Locations

1 site across 1 country: Ukraine