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Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter

NCT ID: NCT01690650

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

33 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. 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.

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.

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.

Conditions

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Response to Hyperoxia

Keywords

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Preterm Newborn Neonate Cerebral oxygenation Oxygen

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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Oxygen + Cerebral NIRS

Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

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.

Interventions

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Oxygen

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Newborns with a gestational age of 32-40 weeks
* Clinically stable
* +/- CPAP with a oxygen limit below 30%
* Parental consent

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

Principal Investigators

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Ole Pryds, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics, Copenhagen University Hospital, Hvidovre

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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Oxygen - HH 527

Identifier Type: -

Identifier Source: org_study_id