SafeBoosC III Two-year Follow-up
- Conditions
- Brain DamageDeficits, NeurologicExtreme Prematurity
- Registration Number
- NCT05134116
- Lead Sponsor
- Gorm Greisen
- Brief Summary
The SafeBoosC-III 2 year follow up study will follow up on all patients randomised in the SafeBoosC-III clinical trial (NCT03770741). The investigators will collect data when the patients are two years of corrected age from routine standardised follow up assessments, parental questionnaires as well as informal assessments. The study will commence in September 2021, and will expect to include all 72 sites across 18 countries, which take part of the SafeBoosC-III clinical trial.
- Detailed Description
In the SafeBoosC-III trial, the objective is to investigate the effect of treatment based on cerebral near-infrared spectroscopy (NIRS) monitoring of brain oxygenation compared with treatment as usual in extremely preterm infants. The primary outcome of the trial is death or survival with severe brain injury at 36 weeks' postmenstrual age. Despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. Therefore, if treatment based on cerebral NIRS monitoring decreases the risks of death or survival with severe brain injury, it is important to document if the beneficial effect persists into early childhood, in the form of 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 long-term patient-relevant benefits outweigh possible harms. As the SafeBoosC-III trial intends to randomise 1600 infants, there is potential to achieve sufficient power for a meaningful assessment of the experimental intervention's effect on long-term neurodevelopment, as well as an evaluation of unexpected harms. The objective of the SafeBoosC III follow-up study is to investigate the benefits and harms of treatment guided by cerebral NIRS monitoring of brain oxygenation in extremely preterm infants during the first 72 hours of life, assessed at two years' corrected age. The hypothesis is that the intervention will decrease a composite of death or moderate-or-severe neurodevelopmental disability at two years' corrected age, and/or increase cognitive function in survivors assessed by the Bayley III/IV test, with insignificant harms. The investigators aim to collect data on as many children as possible and will do this by collecting clinical data from health care records as well as answers from parental questionnaires.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1601
Participation in the SafeBoosC-III trial and enrollment in a neonatal intensive care unit (NICU) taking part in the follow-up study, with parental consent according to local regulations.
Parental objection to the use of their child's data in the follow-up study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death or moderate-or-severe neurodevelopmental disability To be assessed at two years of corrected age A child will be classified with moderate-or-severe neurodevelopmental disability if they have been diagnosed with cerebral palsy, a cognitive function score below -2 standard deviations from the norm, hearing impairment, or vision impairment or from data from a parental questionnaire.
Mean Bayley III/IV cognitive score To be assessed at two years of corrected age The cognitive scores from the Bayley III/IV assessment will constitute a single continuous outcome measure (higher scores meaning better outcomes)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Righospitalet (The University Hospital, Copenhagen)
🇩🇰Copenhagen, Denmark