Clinical trial NCT05134116: SafeBoosC III Two-year Follow-up
Official title: Cerebral Near-infrared Spectroscopy Monitoring Versus Treatment as Usual for Extremely Preterm Infants: a Protocol for the Follow-up Study for the SafeBoosC-III Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deficits, Neurologic
Extreme Prematurity
Brain Damage
Keywords: Neurodevelopmental disability
Cerebral palsy
Neurosensory deficits
Cognitive disability
Follow up study
Extremely preterm birth
Near infrared spectroscopy (NIRS)
Cerebral oximetry
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 1601
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born below 28 weeks of gestation and randomised in the SafeBoosC-III trial

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

Parental objection to the use of their child's data in the follow-up study.

Primary outcomes:
measure: Death or moderate-or-severe neurodevelopmental disability
timeFrame: To be assessed at two years of corrected age
measure: Mean Bayley III/IV cognitive score
timeFrame: To be assessed at two years of corrected age
Secondary outcomes:
Other outcomes:
measure: Daily medication the last two months (yes/no)
timeFrame: To be assessed at two years of corrected age
measure: Any other chronic illness (defined as any problem which has been diagnosed by a doctor and which 1) is expected to last more than a few months, 2) causes problems in everyday life, or 3) is a risk of early death or disability),
timeFrame: To be assessed at two years of corrected age
measure: Growth measurements
timeFrame: To be assessed at two years of corrected age
measure: Components of the co-primary outcomes
timeFrame: To be assessed at two years of corrected age
Locations:
city: Copenhagen
country: Denmark
facility: Righospitalet (The University Hospital, Copenhagen)
Study officials:
References: