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Clinical Trials/NCT01690650
NCT01690650
Completed
Not Applicable

Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter

Copenhagen University Hospital, Hvidovre1 site in 1 country33 target enrollmentSeptember 2012
InterventionsOxygen
DrugsOxygen

Overview

Phase
Not Applicable
Intervention
Oxygen
Conditions
Response to Hyperoxia
Sponsor
Copenhagen University Hospital, Hvidovre
Enrollment
33
Locations
1
Primary Endpoint
Changes from baseline of cerebral oxygen saturation after oxygen exposure.
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

  • 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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Copenhagen University Hospital, Hvidovre
Responsible Party
Principal Investigator
Principal Investigator

Line Carøe Sørensen

MD, PH.D.

Copenhagen University Hospital, Hvidovre

Eligibility 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

Arms & Interventions

Oxygen + Cerebral NIRS

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

Intervention: Oxygen

Outcomes

Primary Outcomes

Changes from baseline of cerebral oxygen saturation after oxygen exposure.

Time Frame: Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up.

Study Sites (1)

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