IntellO2 vs Manual Control for Optimizing Oxygenation in Infants
Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy
1 other identifier
interventional
36
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2014
CompletedFirst Posted
Study publicly available on registry
February 28, 2014
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJune 27, 2018
June 1, 2018
1 year
February 26, 2014
June 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent time in target range for oxygen saturation by pulse oximetry
24 hrs
Study Arms (2)
IntellO2
EXPERIMENTALAutomated control of FiO2
Manual
ACTIVE COMPARATORManual control of FiO2
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vapotherm, Inc.lead
- Ashford and St. Peter's Hospitals NHS Trustcollaborator
- Oxford University Hospitals NHS Trustcollaborator
Study Sites (2)
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Ashford and St. Peter's Hospitals NHS Trust
Chertsey, Surrey, KT16 0QA, United Kingdom
Related Publications (1)
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.
PMID: 30464005DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Reynolds, MB.BS PhD
Ashford and St. Peter's Hospitals NHS Trust
- STUDY DIRECTOR
George C Dungan, MPhil
Vapotherm, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2014
First Posted
February 28, 2014
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
January 1, 2018
Last Updated
June 27, 2018
Record last verified: 2018-06