Response to HyperoxiaNCT01690650
Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter
A study testing Oxygen in people with Response to Hyperoxia, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 hour to 4 weeks
- Conditions the study is for
- Response to Hyperoxia
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 4 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with a gestational age of 32-40 weeks
- Clinically stable
- +/- CPAP with a oxygen limit below 30%
- Parental consent
Who cannot join
- Severe birth asphyxia
- Prohibition of oxygen exposure
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Paediatrics, Copenhagen University Hospital; Hvidovre
Hvidovre, 2650
About this study
Official title: 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. 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.
Read the 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.
- Conditions
- Response to Hyperoxia
- Being tested
- Oxygen
- Keywords
- Preterm, Newborn, Neonate, Cerebral oxygenation, Oxygen
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen + Cerebral NIRS | Experimental | Induced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation. Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline of cerebral oxygen saturation after oxygen exposure.
Measured: Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Response to HyperoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- The Ludvig & Sara Elsass Foundation
- Responsible party
- Principal investigator, Line Carøe Sørensen, Copenhagen University Hospital, Hvidovre
- Investigators
- Ole Pryds, Professor, Principal investigator, Department of Paediatrics, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690650
- Sponsor's protocol ID
- Oxygen - HH 527
- Status last verified
- Nov 2013
- First submitted
- 20 Jun 2011
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter
- ClinicalTrials.gov ID
- NCT01690650
- Acronym / sponsor ID
- Oxygen - HH 527
- Conditions
- Response to Hyperoxia
- Keywords
- Preterm, Newborn, Neonate, Cerebral oxygenation, Oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- The Ludvig & Sara Elsass Foundation
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxygen + Cerebral NIRS | Experimental | Drug: OxygenInduced changes in oxygen supply (100% vs. room air). Continuously monitoring of cerebral oxygen saturation. |
Who may qualify
- Ages
- 1 hour to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborns with a gestational age of 32-40 weeks
- Clinically stable
- +/- CPAP with a oxygen limit below 30%
- Parental consent
Key exclusion criteria (2 listed)
- Severe birth asphyxia
- Prohibition of oxygen exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenOxygen 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. | Drug | Oxygen + Cerebral NIRS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Pryds, Professor principal investigator
Department of Paediatrics, Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Response to Hyperoxia, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.