IntellO2 vs Manual Control for Optimizing Oxygenation in... | NCT02074774

Studies
IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

NCT02074774

Sponsor

Vapotherm, Inc.

Status

Completed

Last Update Posted

Jun 27, 2018Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Oxygen Titration in Preterm Infants to Manage Lung Disease

Interventions

IntellO2
Manual control

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Jan 2018Actual

First Submitted Date

Feb 26, 2014

First Submission Date that Met QC Criteria

Feb 26, 2014

First Posted Date

Feb 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2018

Last Update Posted Date

Jun 27, 2018Actual

Name	Class
Ashford and St. Peter's Hospitals NHS Trust	OTHER
Oxford University Hospitals NHS Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IntellO2	Experimental	Automated control of FiO2	Device: IntellO2
Manual	Active Comparator	Manual control of FiO2	Other: Manual control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IntellO2	Device	Automated FiO2 regulator that responds to pulse oximetry measures	IntellO2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent time in target range for oxygen saturation by pulse oximetry		24 hrs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Reynolds, MB.BS PhD	Ashford and St. Peter's Hospitals NHS Trust	Principal Investigator
George C Dungan, MPhil	Vapotherm, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oxford University Hospitals NHS Trust		Oxford	Oxfordshire	OX3 9DU	United Kingdom
Ashford and St. Peter's Hospitals NHS Trust

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30464005	Derived	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.