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Trial registered on ANZCTR


Registration number
ACTRN12619000742178
Ethics application status
Approved
Date submitted
24/02/2019
Date registered
17/05/2019
Date last updated
17/05/2019
Date data sharing statement initially provided
17/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Controlled oxygen administration in term newborns and young infants requiring mechanical respiratory support and oxygen therapy
Scientific title
Effect of automated control of oxygen administration on oxygen saturation targeting in term newborns and young infants requiring mechanical respiratory support and oxygen therapy
Secondary ID [1] 297516 0
Nil known
Universal Trial Number (UTN)
Trial acronym
COATI study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal hypoxic respiratory failure 311719 0
Respiratory tract infection of infancy 311720 0
Condition category
Condition code
Respiratory 310343 310343 0 0
Other respiratory disorders / diseases
Infection 310798 310798 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Automated control of inspired oxygen therapy will be administered using a novel adaptive algorithm (VDL1.1), that has been embedded in a commercial ventilator (SLE6000) as the OxyGenie option. This device receives SpO2 input from an oximeter, compares the value with the midpoint of the desired SpO2 range, and provides an output, which is an updated value for FiO2. Automated oxygen control using the SLE6000 + OxyGenie will be compared with standard manual control in a crossover study of 24.5 hours duration. Time spent within the SpO2 target range will be compared during 12 hour periods of automated oxygen control (OxyGenie function on the SLE6000) and manual oxygen control, in random sequence, with a 30 minute washout period between the two epochs. The SpO2 target range will be 92-96% for both manual and automated control.There will be a 30 minute wash out period between interventions. A further 24.5 hour study could commence if the infant remains eligible, after a 30 minute washout. Comparison will also be made of time spent in hypoxic and hyperoxic SpO2 ranges, frequency of hypoxic and hyperoxic episodes, overall oxygen requirement and frequency of manual FiO2 adjustments. Adherence with automated control, and conversely, the use of the manual override option when in automated control, will also be assessed using the 1 Hz data log extracted from the SLE6000 ventilator.
Intervention code [1] 313755 0
Treatment: Devices
Comparator / control treatment
Standard manual control of oxygen therapy (with the participants supported by the SLE6000 ventilator.
Control group
Active

Outcomes
Primary outcome [1] 319219 0
Proportion of time within the SpO2 target range (SpO2 92-96%, inclusive). This proportion will be determined for the entire period of manual control, and automated control, for each subject.

This outcome will be assessed using pulse oximetry measures recorded and logged by the SLE6000 ventilator,
Timepoint [1] 319219 0
At completion of the 2 x 12 hour crossover study
Secondary outcome [1] 367348 0
Proportion of time spent within hypoxic SpO2 ranges. This proportion will be determined for the entire period of automated control and manual control for each participant.
Hypoxic SpO2 ranges are:
• SpO2 <80%
• SpO2 80-84%
• SpO2 85-89%

The time in in hypoxia will be determined using the 1 Hz data log extracted from the SLE6000 ventilator.
Timepoint [1] 367348 0
At the end of the 2 x12 hour crossover study
Secondary outcome [2] 370384 0
Proportion of time spent within hyperoxic SpO2 ranges. This proportion will be determined for the entire period of automated control and manual control for each participant.

Hyperoxic SpO2 ranges are:
• SpO2 >96% when receiving supplemental oxygen
• SpO2 >98% when receiving supplemental oxygen

The time in in hyperoxia will be determined using the 1 Hz data log extracted from the SLE6000 ventilator.
Timepoint [2] 370384 0
At the end of the 2 x12 hour crossover study

Eligibility
Key inclusion criteria
Term newborns with hypoxic respiratory failure, and young infants with respiratory insufficiency related to respiratory tract infection, fulfilling the eligibility criteria outlined below.
Participants will be assigned to a randomised trial treatment only if they meet all of the inclusion criteria and none of the exclusion criteria.

Inclusion criteria
Each participant must meet all of the following criteria in either study population (‘Study group A’ or Study group B’) to be enrolled in the study.

Study group A: Term and near-term infants requiring mechanical respiratory support and oxygen therapy of any duration due to hypoxic respiratory failure (HRF).
• Gestation at birth greater than or equal to 35 completed weeks.
• Chronological age less than or equal to 2 months.
• HRF related to any of parenchymal lung disease, neonatal acute respiratory distress syndrome, pulmonary hypertension or diaphragmatic hernia
• Receiving non-invasive respiratory support (CPAP and HFNC), or intubated and mechanically ventilated using any of the modes available with the SLE6000 ventilator.

Study group B: Young infants requiring non-invasive or invasive mechanical respiratory support and supplemental oxygen therapy of any duration secondary to RTI.
• Any gestation at birth.
• Chronological age less than or equal to 9 months and corrected gestational age less than or equal to 6 months
• Respiratory insufficiency due to respiratory tract infection (viral or bacterial)
• Receiving non-invasive respiratory support (CPAP and HFNC), or intubated and mechanically ventilated using any of the modes available with the SLE6000 ventilator.


For participants in both groups, the following inclusion criteria must be met:
• Supplemental oxygen therapy being administered at study entry (baseline oxygen requirement at least 30%).
• SLE6000 ventilator with OxyGenie® option available for the study.
• Research team available to commence recording.
• Agreement of treating clinicians that the participant is appropriate for study.
Minimum age
No limit
Maximum age
9 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria (common to both study groups):
• Cardiorespiratory instability that precludes entry into a study.
• Change in mode of respiratory support anticipated in next 24 hours.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The intervention sequence will not be revealed until the participant has been deemed to be eligible, consent obtained and the SLE6000 ventilator is in place at the bedside. Concealment of allocation will be by the use of a web-based randomisation schedule prepared by the study statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-based algorithm will be used to generate the sequence of the interventions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Up to two crossover studies will be allowed in a single participant if they remain eligible.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For each study group, primary outcome comparison between automated and manual control epochs will take into account patient effects, period effects as well as the effects of the intervention. Statistical significance will be assumed where P<0.05. Analysis of covariance will be used to determine whether the results are influenced by covariates such as gestation at birth, severity and nature of lung disease, and mode of ventilation at the time of study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/05/2019
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
70
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13245 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 25804 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 302075 0
Other Collaborative groups
Name [1] 302075 0
Murdoch Childrens Research Institute
Country [1] 302075 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Childrens Research Institute
Address
Flemington Road,
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 301891 0
None
Name [1] 301891 0
Address [1] 301891 0
Country [1] 301891 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302755 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 302755 0
Ethics committee country [1] 302755 0
Australia
Date submitted for ethics approval [1] 302755 0
09/01/2019
Approval date [1] 302755 0
08/04/2019
Ethics approval number [1] 302755 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91286 0
Prof Peter Dargaville
Address 91286 0
Menzies Institute for Medical Research,
University of Tasmania
17 Liverpool St, Hobart TAS 7000
Country 91286 0
Australia
Phone 91286 0
+61 400546738
Fax 91286 0
Email 91286 0
[email protected]
Contact person for public queries
Name 91287 0
Peter Dargaville
Address 91287 0
Menzies Institute for Medical Research,
University of Tasmania

17 Liverpool St, Hobart TAS 7000
Country 91287 0
Australia
Phone 91287 0
+61 400546738
Fax 91287 0
Email 91287 0
[email protected]
Contact person for scientific queries
Name 91288 0
Peter Dargaville
Address 91288 0
Menzies Institute for Medical Research,
University of Tasmania

17 Liverpool St, Hobart TAS 7000
Country 91288 0
Australia
Phone 91288 0
+61 400546738
Fax 91288 0
Email 91288 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Summary data will be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.