Detailed funding history of the SafeBoosC project

In 2009 Gorm Greisen got a small grant from the Elsass Foundation to invite interested neonatologists and academic technologists to a inaugural meeting in Dragør, near Copenhagen airport that led to an application to the Danish Strategic Research Council which rejected at the first phase, among 113 applications.

No suitable EU-call could be identified, and time was used to develop the first version of ‘OxyPrem’, an improved device for oximetry in preterm infants. A new application to the Danish Strategic Research Council was submitted in April 2010, and again rejected. In June 2010 we got approval of the plans for the randomized clinical trial from ECRIN. In October 2010 we had organized a larger European consortium and submitted a stage-1 application to EU/FP7 for 11 million Euro to enroll 4100 extremely preterm infants in a phase-III randomized clinical trial in 12 countries during a three year-period. 

We met in Copenhagen just before Christmas2010 to plan, in spite of learning that our stage-1 submission was rejected a few days before. We began the development of a physiology-based treatment guideline, to develop a full protocol for a phase-2 trial with ‘burden of hypoxia-and-hyperoxia’ as the primary outcome (SafeBoos, and to do a pilot-trial in Copenhagen. In April 2011 we met again in Copenhagen. In August we were granted 200.000 dkk for preparations, and applied for the third time to the Danish Strategic Research Council and were granted 11 million dkk (1.3 million Euro) in November 2011. 

In 2015, after the completion of SafeBoosCII, we formed a group of 93 neonatal units in 17 European countries and applied to the Horizon2020 research program

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 we were granted 600,000 dkk from the Elsass Foundation to cover the remaining expenses to Copenhagen Trial Unit. This grant also meant that all central trial expenses for SafeBoosC-III were covered.