January 2018 | Eanáir 2018

Enrolment Commences in Neonatal Clinical Trial

Wed, 10 January 18 18:57

Investigators at the National Maternity Hospital have commenced enrolment of neonates into an European paediatric clinical study to investigate if prophylactic oropharyngeal surfactant at birth can reduce the rate of endotracheal intubation for respiratory failure within 120 hours of birth.

The Paediatric Clinical Research Infrastructure Network (PedCRIN) was founded in response to the widely acknowledged difficulties in conducting investigator-led trials of investigational medicinal products in children.  PedCRIN brings together the European Clinical Research Infrastructure Network (ECRIN) and the founding partners of the European Paediatric Clinical Trial Research Infrastructure (EPCT-RI) and is funded by the European Union’s Horizon 2020 programme. 

Launched in January 2017, PedCRIN is a four year project which aims to develop capacity for the management of multi-national paediatric non-commercial clinical trials.  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 mininising risk and protecting the child participants.

In February 2017, PedCRIN invited applications for funding for investigator-led multi-country paediatric or neonatal clinical studies on medicine products trials that would be conducted in Europe. Three awards were made from 13 applications from six coordinating countries, Ireland, France, Norway, Italy, Germany and the UK.

Prof Colm O’Donnell (UCD Full Clinical Professor and consultant neonatologist at the National Maternity Hospital, Holles Street was among one of the successful applicant groups.  The group secured funding of €430,000 from PedCRIN to support the POPART (Prophylactic Oropharyngeal Surfactant for Preterm infant: A Randomised Trial) trial.  The POPART trial which commenced in June 2017 will determine whether, among infants born before 29 weeks of gestation, does prophylactic oropharyngeal surfactant at birth compared to no intervention, reduce the rate of endotracheal intubation for respiratory failure within 120 hours of birth?

This trial will enrol 250 infants in several European countries (Ireland, Sweden, Norway, Denmark, Czech Republic, Italy, Portugal). Recruitment started at the National Maternity Hospital in Dublin in mid-December 2017 and to date 5 babies have been enrolled at the Dublin maternity hospital.  The trial is sponsored by UCD and forms the central part of current PhD research by Dr. Madeleine Murphy, a Clinical Research Fellow funded by the National Children’s Research Centre.

More information: http://www.ecrin.org/projects/pedcrin/call-outcome