Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter
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| First Received Date ICMJE | September 11, 2012 | ||||||||
| Last Updated Date | October 11, 2012 | ||||||||
| Start Date ICMJE | September 2012 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01684618 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter | ||||||||
| Official Title ICMJE | Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter | ||||||||
| Brief Summary |
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| 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. 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Cerebral Oxygenation | ||||||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | 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
Intervention: Procedure: Cerebral NIRS Oximetry + CPAP |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | July 2013 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 4 Weeks | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01684618 | ||||||||
| Other Study ID Numbers ICMJE | CPAP - HH 527 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Line Carøe Sørensen, Copenhagen University Hospital, Hvidovre | ||||||||
| Study Sponsor ICMJE | Copenhagen University Hospital, Hvidovre | ||||||||
| Collaborators ICMJE | The Ludvig & Sara Elsass Foundation | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Copenhagen University Hospital, Hvidovre | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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