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

NCT ID: NCT01690650

Last Updated: 2013-11-08

Basic Information

• 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

• 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.

Conditions

Response to Hyperoxia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

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

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

The Ludvig & Sara Elsass Foundation

UNKNOWN

Sponsor Role: collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: lead

Responsible Party

Line Carøe Sørensen

MD, PH.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ole Pryds, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatrics, Copenhagen University Hospital, Hvidovre

Locations

Department of Paediatrics, Copenhagen University Hospital; Hvidovre

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

Oxygen - HH 527

Identifier Type: -

Identifier Source: org_study_id