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

Not Applicable

Completed

• Conditions: Response to Hyperoxia
• Interventions: Drug: Oxygen

• Registration Number: NCT01690650
• Lead Sponsor: Copenhagen University Hospital, Hvidovre

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.

Study Timeline

• Study First Submitted: 2011-06-20
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-24
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-06
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxygen + Cerebral NIRS	Oxygen	Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.

Primary Outcome Measures

Name	Time	Method
Changes from baseline of cerebral oxygen saturation after oxygen exposure.	Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up.

Trial Locations

Locations (1)

Department of Paediatrics, Copenhagen University Hospital; Hvidovre; 🇩🇰 Hvidovre, Denmark