Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter
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|ClinicalTrials.gov Identifier: NCT01684618|
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : November 8, 2013
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Oxygenation||Procedure: Cerebral NIRS Oximetry + CPAP||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. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 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: Cerebral NIRS oximetry + CPAP
Cerebral NIRS oximetry, using the INVOS Cerebral/Somatic Oximeter, and changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure
Procedure: Cerebral NIRS Oximetry + CPAP
CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once
Other Name: INVOS 5100C Oximeter
- Changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure [ Time Frame: Measurements will take between 30 minutes and 3 hours depending of situation. Within the first 4 weeks of life. ]
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): NCT01684618
|Department of Paediatrics, Copenhagen University Hospital; Hvidovre|
|Hvidovre, Denmark, 2650|