Early treatment versus expectative management of patent ductus arteriosus in preterm infants: a multicentre, randomised, non-inferiority trial in Europe (BeNeDuctus trial)

Abstract

Use of paracetamol has been associated with closure of a PDA in studies with only a limited number of preterm infants [27–35]. [...]the high dose of paracetamol (60 mg/kg/day) that is used to close the PDA gives rise to concerns about safety in preterm infants [36–38]. [...]the conservative management was rather heterogeneous, ranging from an expectative management to fluid restriction, diuretics and/or adapted ventilator settings. [...]although these studies suggest that an expectative approach does not seem to be associated with an increased incidence of neonatal mortality or morbidity, convincing evidence supporting this wait-and-see policy is still lacking, especially in preterm infants born at less than 28 weeks’ gestation. [...]per arm full cost-prices will be determined using the Dutch guideline [105], or else real cost prices via activity based costing or centre-specific cost information. [...]the interim analyses will not be associated with alpha spending.