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

Not Applicable

Completed

• Conditions: Cerebral Oxygenation
• Interventions: Procedure: Cerebral NIRS Oximetry + CPAP

• Registration Number: NCT01684618
• Lead Sponsor: Copenhagen University Hospital, Hvidovre

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-13
• 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: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cerebral NIRS oximetry + CPAP	Cerebral NIRS Oximetry + CPAP	Cerebral NIRS oximetry, using the INVOS Cerebral/Somatic Oximeter, and changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure

Primary Outcome Measures

Name	Time	Method
Changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure	Measurements will take between 30 minutes and 3 hours depending of situation. Within the first 4 weeks of life.

Trial Locations

Locations (1)

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