Trial | NCT01690650  Report issue

Title

Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter
Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    oxygen ...

  • Study Participants

    33
Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. The investigators 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 cerebral vasoconstriction after oxygen exposure is prolonged in preterm infants compared to term infants.
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.

The investigators will examine the normal physiological cerebral response to exposure of oxygen in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants.

The investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). Reproducibility is examined by repeated measurements.

There will be no follow-up.
Study Started
Sep 30
2012
Primary Completion
Aug 31
2013
Study Completion
Aug 31
2013
Last Update
Nov 08
2013
Estimate

Drug Oxygen

Oxygen exposure (100% oxygen) for 5 minutes, then 25 minutes with room air. Repeated twice. Continuously monitoring of the cerebral oxygen saturation (NIRS).5 replacements of sensor for reproducibility.

Oxygen + Cerebral NIRS Experimental

Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.

Criteria 

Inclusion Criteria:

Newborns with a gestational age of 32-40 weeks
Clinically stable
+/- CPAP with a oxygen limit below 30%
Parental consent

Exclusion Criteria:

Severe birth asphyxia
Prohibition of oxygen exposure
No Results Posted