Safeguarding the brain of our smallest children – a phase III randomised clinical trial on near-infrared spectroscopy monitoring combined with a treatment guideline in premature infants with clinically relevant outcomes

The aim is to conduct a large, pragmatic trial in extremely preterm babies to examine if cerebral oximetry combined with the treatment guideline can reduce the risk of death or severe brain injury at 36 weeks of age from 34% in the control group to 26% in the experimental group.

SafeBoosC-III will use any oximeter that is approved for clinical use that has been calibrated in the blood-lipid phantom to define the hypoxic threshold for clinical action. This makes it a trial of the generic principle of tissue oximetry-guided therapy.

In 2015 we formed a group of 93 neonatal units in 17 European countries and applied to the Horizon2020 research programme

In 2016 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 ElsassFonden. 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 applied to the Medtronics Foundation, to cover local GCP expenses and insurance. This was not granted.  On the other hand, the industries Masimo, EnginMed and OxyPrem contribute and many hospitals have obtained funding to cover local costs.
By the end of 2019, the protocol and statistical analysis plan has been submitted for publication, web-based systems for training and certification as well as randomization and data collection are up and running, 40 hospitals have obtained ethical approval, contracts are being signed, and 8 hospitals are actively enrolling babies.

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