In 2015 we formed a group of 93 neonatal units in 17 European countries and applied to the Horizon2020 research programme
In 2016 we formed a consortium with 10 national partners and applied to the Irish Heath Research Board in 2016 - we were not funded.
We then considered a cluster randomized design. The SafeBoosC intervention is complex: Monitoring of cerebral oxygenation as well as implementation of the treatment guideline 24/7. This means that many clinical staff members are involved and therefore a cluster design would be appropriate. But such a design would require the participation of approximately 140 NICUs.
In 2017 we applied to the NovoNordicFoundation for a trial planning to involve 50 NICUs to enroll 1600 infants in a pragmatic, individually randomized clinical trial over a period of two years. This was not granted.
In April 2018 the initial trial center costs for a trial with this design were funded by Elsass Fonden with a total of 2,700,000 dkk. Twenty national coordinators were identified and 125 NICUs from Europe, China and the US showed interest and in November we hosted investigators from 70 hospitals at hotel BellaSky in Copenhagen.
In 2018 we also applied to the Medtronics Foundation, to cover local GCP expenses and insurance. This was not granted. On the other hand, the industries EnginMed and OxyPrem contribute and many hospitals have obtained funding to cover local costs.
In 2019 we were granted 1,000,000 dkk from Svend Andersen Foundation and Aage and Johanne Louis-Hansen Foundation, respectively. This funding will cover expenses to Copenhagen Trial Unit, three additional investigator meetings and one year extra salary to the trial manager.
In 2020 January, we held the second investigator meeting at Bella Sky in Copehagen with investigators from 60 hospitals participating.
- Austria: Gerhard Pichler, Graz, firstname.lastname@example.org
- Belgium: Gunnar Naulaers, Leuven, email@example.com
- China: Guoquiang Chen, Shanghai, firstname.lastname@example.org
- Czech Republic: Jakub Tkaczyk, Prague,
- Denmark: Simon Hyttel-Sørensen, Copenhagen,
- Germany: Hans Fuchs, Freiburg, email@example.com
- Greece: Gabriel Dimitriou, Patras, firstname.lastname@example.org
- India: Saudamini Nesargi, Bangalor, email@example.com
- Ireland: Eugene Dempsey, Cork, firstname.lastname@example.org
- Italy: Monica Fumagalli, Milan, email@example.com
- Norway: Siv Fredly, Oslo, UXSIDL@ous-hf.no
- Poland: Tomasz Szczapa, Poznan, firstname.lastname@example.org
- Portugal: Ana Vilan, Porto,
- Switzerland: Cornelia Hagmann, Zurich,
- United Kingdom: Anne Marie Heuchan, Glasgow, email@example.com
- Spain: Adelina Pellicer, Madrid, firstname.lastname@example.org
- Turkey: Ebru Ergenekon, Ankara, email@example.com
- USA: Jonathan MIntzer, Montclair, NJ, firstname.lastname@example.org
- Gorm Greisen, Coordinating investigator
- Mathias Lühr Hansen, Trial manager
- Janus Christian Jakobsen, Copenhagen Trial Unit
- Christian Gluud, Copenhagen Trial Unit
- Simon Hyttel-Sørensen, National coordinator, Denmark
- Jonathan Mintzer, National coordinator, USA
- Eugene Dempsey, National coordinator, Ireland
- Adelina Pellicer, Natonal Coordinator, Spain
Neonatal Intensive Care Units
participating NICUs in SafeBoosC III
will be continuously updated, as national coordinators report on NICUS that wants to be a part of the trial.