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

Primary Purpose

Response to Hyperoxia

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Oxygen

About this trial

This is an interventional basic science trial for Response to Hyperoxia focused on measuring Preterm, Newborn, Neonate, Cerebral oxygenation, Oxygen

Eligibility Criteria

1 Hour - 4 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Paediatrics, Copenhagen University Hospital; Hvidovre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxygen + Cerebral NIRS

Arm Description

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

Outcomes

Primary Outcome Measures

Changes from baseline of cerebral oxygen saturation after oxygen exposure.

Secondary Outcome Measures

Full Information

NCT ID

NCT01690650

First Posted

June 20, 2011

Last Updated

November 6, 2013

Sponsor

Copenhagen University Hospital, Hvidovre

Collaborators

The Ludvig & Sara Elsass Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01690650

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Copenhagen University Hospital, Hvidovre

Collaborators

The Ludvig & Sara Elsass Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Response to Hyperoxia

Keywords

Preterm, Newborn, Neonate, Cerebral oxygenation, Oxygen

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxygen + Cerebral NIRS

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Oxygen

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes from baseline of cerebral oxygen saturation after oxygen exposure.

Time Frame

Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Hour

Maximum Age & Unit of Time

4 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ole Pryds, Professor

Organizational Affiliation

Department of Paediatrics, Copenhagen University Hospital, Hvidovre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Paediatrics, Copenhagen University Hospital; Hvidovre

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

12. IPD Sharing Statement

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

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