Cerebral Oxygenation Clinical Trial
Official title:
Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter
- Due to the increased risk of brain damage, continuous monitoring of the cerebral
oxygenation is interesting. We will evaluate the capability of the INVOS Oximeter to
detect induced changes in the cerebral regional saturation.
- The purpose of the study is to investigate our hypothesis that a particular CPAP flow
pressure optimizes the regional cerebral oxygenation.
Preterm infants are at increased risk of brain damage compared with term infants, and
cerebral hypoxia is considered to have an important role. The preterm infants are at
increased risk of respiratory distress, episodes with low oxygenation, mechanical
ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can
affect the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a
point of interest, since high levels of oxygen can cause vasoconstriction. Preterm infants
is often treated with CPAP (Continuous positive airway pressure), but the effect of
different flow pressures on the regional cerebral oxygenation is not known.
The investigators will examine the normal physiological response of the brain in a group of
preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants to
the commonly used treatment in neonatology, CPAP (Continuous positive airway pressure).
The investigators will do dynamic research with continuously monitoring of the cerebral
oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)).
INVOS® is the first NIRS-based oximeter CE-approved for hospital use in Denmark.
There will be no follow-up.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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