Oxygen ToxicityANOXneoNCT02698020
Optimized Oxygen Delivery During General Anesthesia in Newborn Infants
A study testing Room-air in people with Oxygen Toxicity and Oxidative Stress, run by Uppsala University at 1 site in Sweden.
Trial summary
An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia. Read more about this study
- Who is it for?
- Ages Up to 4 weeks
- Conditions the study is for
- Oxygen Toxicity, Oxidative Stress
- What is being tested?
- Room-air
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2015to 10 Oct 2018
- 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 Up to 4 weeks
- All sexes
- No healthy volunteers
- Child
- Newborn less than 44 weeks postconceptional age
- No pulmonary disease, no oxygen requirement, or assisted ventilation
- No genetic syndrome
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Uppsala University Hospital, Pediatric anesthesia Unit
Uppsala, 75185
About this study
Official title: Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.
An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.
Read the detailed description
Eligible infants are infants of less than 44 weeks postconceptional age and without pulmonary disease or demand for supplemental oxygen or assisted ventilation. Control subjects receive current standard of care (anesthesia induction/pre-oxygenation with 80%, maintenance of anesthesia with 40%, and recovery with 80% inspired oxygen). Intervention subjects are maintained on room air throughout the procedure and supplemental oxygen added only if necessary according to the pre-specified oxygen saturation target. Subjects are monitored according to clinical protocols AND with cerebral oximetry (NIRS), transcutaneous measurement of partial pressure of oxygen (pO2), and blood-gas analyses. Blood and urine samples are collected for later analysis of markers for oxidative stress.
- Conditions
- Oxygen Toxicity, Oxidative Stress
- Being tested
- Room-air
- Keywords
- Newborn, Anesthesia, Oxygen, Hyperoxia
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Room-airProcedure or surgery
Provision of room-air
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | High level of supplemental inspired oxygen |
| Room-air | Experimental | Supplemental oxygen only provided if oxygen saturation below target Receives: Procedure: Room-air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous and blood-gas pO2
Area under curve (AUC) and absolute values of pO2
Measured: 30 min
Secondary outcomes (3)
Cerebral Oximetry
AUC of O2 saturation
Measured: 30 min
Atelectasis
Reduced lung compliance as a measure of atelectasis formation
Measured: 30 min
Isoprostane
Level of isoprostanes in blood and urine
Measured: 4 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startNov 2015
- Primary completion30 Jul 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen ToxicityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Agren, MD, PhD, Principal investigator, Department of Women's and Children's Health, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698020
- Sponsor's protocol ID
- ANOXneo
- Acronym
- ANOXneo
- Status last verified
- Oct 2018
- First submitted
- 25 Feb 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.
- ClinicalTrials.gov ID
- NCT02698020
- Acronym / sponsor ID
- ANOXneo / ANOXneo
- Conditions
- Oxygen Toxicity, Oxidative Stress
- Keywords
- Newborn, Anesthesia, Oxygen, Hyperoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 3 Mar 2016 (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.
An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.
Detailed description
Eligible infants are infants of less than 44 weeks postconceptional age and without pulmonary disease or demand for supplemental oxygen or assisted ventilation. Control subjects receive current standard of care (anesthesia induction/pre-oxygenation with 80%, maintenance of anesthesia with 40%, and recovery with 80% inspired oxygen). Intervention subjects are maintained on room air throughout the procedure and supplemental oxygen added only if necessary according to the pre-specified oxygen saturation target. Subjects are monitored according to clinical protocols AND with cerebral oximetry (NIRS), transcutaneous measurement of partial pressure of oxygen (pO2), and blood-gas analyses. Blood and urine samples are collected for later analysis of markers for oxidative stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –High level of supplemental inspired oxygen |
| Room-air | Experimental | Procedure: Room-airSupplemental oxygen only provided if oxygen saturation below target |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Room-airProvision of room-air | Procedure or surgery | Room-air |
Primary outcome
Transcutaneous and blood-gas pO2
Time frame: 30 min
Area under curve (AUC) and absolute values of pO2
3 secondary outcomes
Cerebral Oximetry
Time frame: 30 min
Atelectasis
Time frame: 30 min
Isoprostane
Time frame: 4 h
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 15 Oct 2018.
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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.
Johan Agren, MD, PhD principal investigator
Department of Women's and Children's Health, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Room-air in people with Oxygen Toxicity and Oxidative Stress, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Oct 2018. 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 Sweden. 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?
Transcutaneous and blood-gas pO2 (time frame: 30 min). 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 15 Oct 2018.