Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter
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|ClinicalTrials.gov Identifier: NCT01690650|
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : November 8, 2013
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Response to Hyperoxia||Drug: Oxygen||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Experimental: Oxygen + Cerebral NIRS
Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.
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.
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690650
|Department of Paediatrics, Copenhagen University Hospital; Hvidovre|
|Hvidovre, Denmark, 2650|
|Principal Investigator:||Ole Pryds, Professor||Department of Paediatrics, Copenhagen University Hospital, Hvidovre|