Oxygen Titration in Preterm Infants to Manage Lung DiseaseNCT02074774
IntellO2 vs Manual Control for Optimizing Oxygenation in Infants
A study testing IntellO2 in people with Oxygen Titration in Preterm Infants to Manage Lung Disease, run by Vapotherm, Inc. at 2 sites in United Kingdom.
Trial summary
The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oxygen Titration in Preterm Infants to Manage Lung Disease
- What is being tested?
- IntellO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Dec 2016to Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants being treated with high flow nasal cannula therapy
- A need for supplemental oxygen as demonstrated by an required FiO2 > 0.25 at enrollment
- Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC).
Who cannot join
- Major congenital abnormalities
- Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics
- Seizures
- Ongoing sepsis
- Meningitis
- Clinician's concern regarding stability of the infant
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Ashford and St. Peter's Hospitals NHS Trust
Chertsey, Surrey, KT16 0QA
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy
The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.
- Being tested
- IntellO2, Manual control
- Keywords
- nasal cannula, high flow oxygen therapy, pulse oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntellO2Device
Automated FiO2 regulator that responds to pulse oximetry measures
Manual controlOther
Standard practice of manually titrating FiO2 as needed.
| Study group | Role | What they receive |
|---|---|---|
| IntellO2 | Experimental | Automated control of FiO2 Receives: Device: IntellO2 |
| Manual | Active comparator | Manual control of FiO2 Receives: Other: Manual control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent time in target range for oxygen saturation by pulse oximetry
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startDec 2016
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxygen Titration in Preterm Infants to Manage Lung DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vapotherm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ashford and St. Peter's Hospitals NHS Trust, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Peter Reynolds, MB.BS PhD, Principal investigator, Ashford and St. Peter's Hospitals NHS TrustGeorge C Dungan, MPhil, Study director, Vapotherm, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074774
- Sponsor's protocol ID
- RP-NIAE2014001Reg
- Status last verified
- Jun 2018
- First submitted
- 26 Feb 2014
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21.
PubMed 30464005
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy
- ClinicalTrials.gov ID
- NCT02074774
- Acronym / sponsor ID
- RP-NIAE2014001Reg
- Keywords
- nasal cannula, high flow oxygen therapy, pulse oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vapotherm, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ashford and St. Peter's Hospitals NHS Trust, Oxford University Hospitals NHS Trust
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 28 Feb 2014 (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.
The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IntellO2 | Experimental | Device: IntellO2Automated control of FiO2 |
| Manual | Active comparator | Other: Manual controlManual control of FiO2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm infants being treated with high flow nasal cannula therapy
- A need for supplemental oxygen as demonstrated by an required FiO2 > 0.25 at enrollment
- Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC).
Key exclusion criteria (6 listed)
- Major congenital abnormalities
- Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics
- Seizures
- Ongoing sepsis
- Meningitis
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 |
|---|---|---|
| IntellO2Automated FiO2 regulator that responds to pulse oximetry measures | Device | IntellO2 |
| Manual controlStandard practice of manually titrating FiO2 as needed. | Other | Manual |
Primary outcome
Percent time in target range for oxygen saturation by pulse oximetry
Time frame: 24 hrs
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 27 Jun 2018.
- Derived from this study: PubMed 30464005Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21.
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.
Peter Reynolds, MB.BS PhD principal investigator
Ashford and St. Peter's Hospitals NHS Trust
George C Dungan, MPhil study director
Vapotherm, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntellO2 in people with Oxygen Titration in Preterm Infants to Manage Lung Disease, run by Vapotherm, Inc. at 2 sites in United Kingdom.
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 3 inclusion and 6 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Percent time in target range for oxygen saturation by pulse oximetry (time frame: 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02074774, which also lists 1 linked publication.
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 27 Jun 2018.