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

NCT ID: NCT01684618

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-08-31

Brief Summary

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* 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

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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

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Cerebral Oxygenation

Keywords

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Preterm Neonate Newborn Cerebral oxygenation CPAP

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Cerebral NIRS Oximetry + CPAP

Intervention Type PROCEDURE

CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once

Interventions

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Cerebral NIRS Oximetry + CPAP

CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once

Intervention Type PROCEDURE

Other Intervention Names

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INVOS 5100C Oximeter

Eligibility Criteria

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Exclusion Criteria

* Severe birth asphyxia - Prohibition of oxygen exposure
Minimum Eligible Age

1 Hour

Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Ludvig & Sara Elsass Foundation

UNKNOWN

Sponsor Role collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role lead

Responsible Party

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Line Carøe Sørensen

MD, PH.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Paediatrics, Copenhagen University Hospital; Hvidovre

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CPAP - HH 527

Identifier Type: -

Identifier Source: org_study_id