Functional and structural brain development in extremely preterm infants

Survival of extremely preterm infants (born <=28 weeks of gestation) has
improved over the last decades, but the high incidence of abnormal
neurodevelopmental outcome remains a reason for concern. The origin of brain
impairment in preterm infants, may be found in the last trimester of gestation.
This critical period for brain development, is spent in the neonatal intensive
care unit, where infants are ventilated for respiratory distress, often
experiencing hemodynamic instability and infections. Early and non-invasive
prediction of neurodevelopmental outcome, using specific and reliable
biomarkers for brain development, will be of outmost importance for clinicians
to improve short and long term outcome in this vulnerable population. We
hypothesize that early and repeated EEG brain monitoring, may be predictive
of 1) later brain maturation and microstructure, assessed using conventional
MRI and diffusion tensor imaging (DTI), 2) later brain function assessed with
resting-state functional MRI (rsfMRI), and 3) long-term neurodevelopmental
outcome.

The main objectives are: to determine whether early and serial EEG brain
monitoring, is a bedside biomarker for later structural brain maturation and
microstructural brain development and to examine whether serially EEG-measured
brain function is related to subsequent resting-state functional MRI (rsfMRI)
data. The secondary objective is to investigate the relation between the most
relevant brain function parameters, predicted by EEG, and long-term
neurodevelopmental outcome in extremely preterm infants.

Study design: Prospective observational cohort study

The population of neonates who are likely to participate in this clinical
investigation are high risk, intensive care patients but there are no
additional risks envisaged with their participation in the Clinical
Investigation. The risk analysis will be updated (if necessary) during the
Clinical Investigation. The study can only be done using extremely preterm born
patients since we want to investigate brain development and the risks linked to
preterm birth.