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.

SafeBoosC III Two-year Follow-up

Deficits, Neurologic

Extreme Prematurity

Brain Damage

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.

Treatment as usual + cerebral oximetry monitoring the first 72 hours of life

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

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.

The cognitive scores from the Bayley III/IV assessment will constitute a single continuous outcome measure (higher scores meaning better outcomes)

SafeBoosC III Two-year Follow-up

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status