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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01684618
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : November 8, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cerebral Oxygenation Procedure: Cerebral NIRS Oximetry + CPAP

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter
Study Start Date : September 2012
Primary Completion Date : August 2013
Study Completion Date : August 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: 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
Procedure: Cerebral NIRS Oximetry + CPAP
CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once
Other Name: INVOS 5100C Oximeter

Outcome Measures

Primary Outcome Measures :
  1. Changes in regional cerebral oxygen saturation, rSO2, during induced changes in CPAP flow pressure [ Time Frame: Measurements will take between 30 minutes and 3 hours depending of situation. Within the first 4 weeks of life. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684618

Department of Paediatrics, Copenhagen University Hospital; Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
The Ludvig & Sara Elsass Foundation
More Information

Responsible Party: Line Carøe Sørensen, MD, PH.D., Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT01684618     History of Changes
Other Study ID Numbers: CPAP - HH 527
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

Keywords provided by Line Carøe Sørensen, Copenhagen University Hospital, Hvidovre:
Cerebral oxygenation