NCT01684618

Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Copenhagen University Hospital, Hvidovre · Academic / Other
• Sex: All
• Age: 1 Hour – 4 Weeks
• Healthy volunteers: Not accepted

Summary

* 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.

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.

Conditions

• Cerebral Oxygenation

Interventions

Type	Name	Description
PROCEDURE	Cerebral NIRS Oximetry + CPAP	CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-09-13
• Last updated: 2013-11-08

Locations

1 site across 1 country: Denmark