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Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01684618
Enrollment
13
Registered
2012-09-13
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

Cerebral Oxygenation

Keywords

Preterm, Neonate, Newborn, Cerebral oxygenation, CPAP

Brief summary

* Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. We 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 a particular CPAP flow pressure optimizes the regional cerebral oxygenation.

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. Preterm infants is often treated with CPAP (Continuous positive airway pressure), but the effect of different flow pressures on the regional cerebral oxygenation is not known. The investigators will examine the normal physiological response of the brain in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants to the commonly used treatment in neonatology, CPAP (Continuous positive airway pressure). The investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). INVOS® is the first NIRS-based oximeter CE-approved for hospital use in Denmark. There will be no follow-up.

Interventions

PROCEDURECerebral NIRS Oximetry + CPAP

CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once

Sponsors

The Ludvig & Sara Elsass Foundation
CollaboratorUNKNOWN
Copenhagen University Hospital, Hvidovre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 4 Weeks
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressureMeasurements will take between 30 minutes and 3 hours depending of situation. Within the first 4 weeks of life.

Countries

Denmark

Outcome results

None listed

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