Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter
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Purpose
- 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 | Intervention |
|---|---|
|
Cerebral Oxygenation |
Procedure: Cerebral NIRS Oximetry + CPAP |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter |
- 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | up to 4 Weeks |
| Genders Eligible for Study: | Both |
| 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| Contact: Line C Sørensen, MD, PH.D. | +4538623310 | lcs@dadlnet.dk |
| Contact: Ole Pryds, Professor | +4538623310 | ole.pryds@hvh.regionh.dk |
| Denmark | |
| Department of Paediatrics, Copenhagen University Hospital; Hvidovre | Recruiting |
| Hvidovre, Denmark, 2650 | |
| Contact: Line C Sørensen, MD, PHD +4538623310 lcs@dadlnet.dk | |
| Contact: Ole Pryds, Professor 4538623310 ole.pryds@hvh.regionh.dk | |
More Information
No publications provided
| 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 |
| Study First Received: | September 11, 2012 |
| Last Updated: | October 11, 2012 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by Copenhagen University Hospital, Hvidovre:
|
Preterm Neonate Newborn Cerebral oxygenation CPAP |
ClinicalTrials.gov processed this record on May 19, 2013