POPART – PedCRIN Funded Trial Commences Recruitment in Europe
The PedCRIN-funded trial POPART (Prophylactic Oropharyngeal Surfactant for Preterm infant: A Randomised Trial) has started recruiting outside Ireland - the sponsor country. This trial will enrol 250 infants in seven European countries: Ireland, Sweden, Norway, Denmark, Czech Republic, Italy, Portugal.
So far, a total of 84 have been enrolled and two of these babies were enrolled at the recently opened sites in Belgium (CHU Liège) and Norway (UNN Tromsø ). Several other sites in the other participating countries are due to open soon.
Launched in January 2017, PedCRIN is a four-year project funded by the European Union’s Horizon 2020 programme (GA 731046). PedCRIN aims to develop the capacity of ECRIN (European Clinical Research Infrastructure) for the management of multi-national paediatric non-commercial clinical trials. PedCRIN was founded in response to the widely acknowledged difficulties in conducting investigator-led trials of investigational medicinal products in children in a multinational setting. PedCRIN seeks to effectively bridge paediatricians and other partners across and beyond Europe to combine resources and expertise to conduct, manage and execute robust studies, whilst minimising risk and protecting the child participants.
The POPART trial will determine whether, among infants born before 29 weeks of gestation, prophylactic oropharyngeal surfactant at birth compared to no intervention reduces the rate of endotracheal intubation for respiratory failure within 120 hours of birth.