- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01690650
Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter
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. 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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hvidovre, Denmark, 2650
- Department of Paediatrics, Copenhagen University Hospital; Hvidovre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oxygen + Cerebral NIRS
Induced changes in oxygen supply (100% vs. room air).
Continuously monitoring of cerebral oxygen saturation.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ole Pryds, Professor, Department of Paediatrics, Copenhagen University Hospital, Hvidovre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Oxygen - HH 527
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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