Rationale

In the SafeBoosC-III trial, we assess the effect on mortality and severe brain injury at 36 weeks of postmenstrual age. However, despite that severe brain injury diagnosed in the neonatal period is associated with later neurodevelopmental disability, the relationship is not always strong. Therefore, if treatment based on cerebral NIRS monitoring decreases the incidence of death and survival with severe brain injury, it is important to document if the beneficial effect persists into early childhood, in the form of a better neurodevelopmental outcome. Furthermore, it is also important to identify evidence of unexpected harms. It would be unfortunate if cerebral NIRS monitoring became standard practice without good evidence that patient-relevant benefits outweigh harms. Since the SafeBoosC-III trial has randomised 1600 participants, there is a potential to follow-up on a large number of infants and thereby, achieve sufficient power for a meaningful test of the intervention’s effect on neurodevelopment, as well as an evaluation of unexpected safety issues. 

Assessment

The SafeBoosC-III two-year follow up study is based on clinical data from routine follow-up between 18 and 30 months of corrected age, e.g. a medical examination, assessments of sensory impairment and assessments of neurodevelopment. Furthermore parents of children included in the SafeBoosC-III trial will be asked to fill out a parental questionnaire consistent of the PARCA-R questionnaire (only non-verbal cognitive) as well as additional questions on health and development.

Timeline and completion

The first randomised infant in SafeBoosC III reached two years of corrected age in September 2021, while the last follow-up assessment is expected to be completed around autumn of 2024, which is when the last infant randomised will reach two years of corrected age plus six months of reserve. So far, 50 centers across Europe, China, India and the US have participants eligible for the two year follow up study.

Below you will find a figure illustrating the study’s data completion from the 2022 and onward.