Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter
This study is currently recruiting participants.
Verified October 2012 by Copenhagen University Hospital, Hvidovre
Sponsor:
Copenhagen University Hospital, Hvidovre
Collaborator:
The Ludvig & Sara Elsass Foundation
Information provided by (Responsible Party):
Line Carøe Sørensen, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT01690650
First received: June 20, 2011
Last updated: October 11, 2012
Last verified: October 2012
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Purpose
- Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. The investigators 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 cerebral vasoconstriction after oxygen exposure is prolonged in preterm infants compared to term infants.
| Condition | Intervention |
|---|---|
|
Response to Hyperoxia |
Drug: Oxygen |
| 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 |
Resource links provided by NLM:
Further study details as provided by Copenhagen University Hospital, Hvidovre:
Primary Outcome Measures:
- Changes from baseline of cerebral oxygen saturation after oxygen exposure. [ Time Frame: Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up. ] [ 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: Oxygen + Cerebral NIRS
Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation.
|
Drug: Oxygen
Oxygen exposure (100% oxygen) for 5 minutes, then 25 minutes with room air. Repeated twice. Continuously monitoring of the cerebral oxygen saturation (NIRS).5 replacements of sensor for reproducibility.
|
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.
The investigators will examine the normal physiological cerebral response to exposure of oxygen in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants.
The investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). Reproducibility is examined by repeated measurements.
There will be no follow-up.
Eligibility| Ages Eligible for Study: | up to 4 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690650
Contacts
| Contact: Line C Sørensen, MD, PHD | +4538623310 | lcs@dadlnet.dk |
| Contact: Ole Pryds, Professor | +4538623310 | ole.pryds@hvh.regionh.dk |
Locations
| 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 | |
| Principal Investigator: Line C Sørensen, MD, PHD | |
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
The Ludvig & Sara Elsass Foundation
Investigators
| Principal Investigator: | Ole Pryds, Professor | Department of Paediatrics, Copenhagen University Hospital, Hvidovre |
More Information
No publications provided
| Responsible Party: | Line Carøe Sørensen, MD, PH.D., Copenhagen University Hospital, Hvidovre |
| ClinicalTrials.gov Identifier: | NCT01690650 History of Changes |
| Other Study ID Numbers: | Oxygen - HH 527 |
| Study First Received: | June 20, 2011 |
| Last Updated: | October 11, 2012 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by Copenhagen University Hospital, Hvidovre:
|
Preterm Newborn Neonate Cerebral oxygenation Oxygen |
Additional relevant MeSH terms:
|
Hyperoxia Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013