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

This study has been completed.
Sponsor:
Collaborator:
The Ludvig & Sara Elsass Foundation
Information provided by (Responsible Party):
Line Carøe Sørensen, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT01684618
First received: September 11, 2012
Last updated: November 6, 2013
Last verified: November 2013

September 11, 2012
November 6, 2013
September 2012
August 2013   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01684618 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter
Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter
  • 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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Cerebral Oxygenation
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
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
Intervention: Procedure: Cerebral NIRS Oximetry + CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
up to 4 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01684618
CPAP - HH 527
No
Line Carøe Sørensen, Copenhagen University Hospital, Hvidovre
Copenhagen University Hospital, Hvidovre
The Ludvig & Sara Elsass Foundation
Not Provided
Copenhagen University Hospital, Hvidovre
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP