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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01690650

Enrollment

Registered

2012-09-24

Start date

2012-09-30

Completion date

2013-08-31

Last updated

2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Response to Hyperoxia

Keywords

Preterm, Newborn, Neonate, Cerebral oxygenation, Oxygen

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.

Interventions

DRUGOxygen

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Hours to 4 Weeks

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

Design outcomes

Primary

Measure	Time frame
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026