Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000203651
Ethics application status
Approved
Date submitted
9/02/2023
Date registered
24/02/2023
Date last updated
1/10/2023
Date data sharing statement initially provided
24/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two variable-flow CPAP devices for respiratory support in premature infants
Scientific title
A single-centre, controlled, within-patient, multi-period study to assess the non-inferiority and safety of a neonatal flow generator to deliver variable-flow CPAP to premature infants requiring respiratory support.
Secondary ID [1] 308963 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature birth 328978 0
Respiratory disease 329034 0
Condition category
Condition code
Reproductive Health and Childbirth 325961 325961 0 0
Complications of newborn
Respiratory 325962 325962 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational device (neonatal flow generator) will be used to deliver variable-flow CPAP to neonates who are already on variable-flow CPAP with the hospitals standard system (SLE1000) in the NICU.
The neonatal flow generator is an integrated air source (blower) and humidifier with an integrated oxygen blender and sensor, and is more portable compared to the SLE1000. The neonatal flow generator has a number of features to improve patient monitoring and safety, and improve usability in the NICU.
To minimize disturbance, all patients receive the sequence of treatment RTR over three periods (Reference ‘R’: variable-flow CPAP via standard hospital system, SLE1000; Treatment ‘T’: variable-flow CPAP via the neonatal flow generator device). That is, the patients will be observed on the standard variable-flow CPAP therapy for 30 minutes to confirm that they are stable, followed by 60 minutes of recorded observation if stable, then the treatment will be swapped to T for 90 minutes, and then the patient is placed back on standard variable-flow CPAP therapy for a final 90 minutes of observation. During each 90-minute observation period, the last 60 minutes is recorded observation. In total, the patients in this study will be under observation in the study for 4.5 hours (with a total of 3 hours being recorded observation).
The investigator will set the pressure of the investigational device to match the pressure of the standard device. The investigator will swap the patients between the devices by changing the patient interface in conjunction with the applicable device. The new device delivers the same therapy as the standard device and will use the same pressure settings, therefore the therapy remains unchanged.
An external pressure logger will be used to measure and confirm the pressure delivered by the investigational device.
Intervention code [1] 325409 0
Treatment: Devices
Comparator / control treatment
Variable-flow CPAP therapy as currently delivered in the Christchurch Hospital NICU using the SLE1000 system. See description of intervention for duration of control periods.
Control group
Active

Outcomes
Primary outcome [1] 333808 0
Difference in SpO2 between intervention and control study phases as recorded from the pulse oximeter, with a noninferiority margin of 2% points.
Timepoint [1] 333808 0
Mean SpO2 is averaged over the 30-minute intervention and 60-minute control study phases
Secondary outcome [1] 418363 0
Difference in mean heart rate between intervention and control study phases, as recorded from the patient monitor
Timepoint [1] 418363 0
Mean heart rate is averaged over the 30-minute intervention and 60-minute control study phases.
Secondary outcome [2] 418364 0
To assess the safety of the neonatal flow generator by recording adverse events and any other relevant safety parameters per treatment, as reported in the medical records.
Timepoint [2] 418364 0
Throughout the 4.5 hour observation period (includes all intervention and control phases).
Secondary outcome [3] 418751 0
Difference in mean respiratory rate between intervention and control study phases, as recorded from the patient monitor
Timepoint [3] 418751 0
.Mean respiratory rate is averaged over the 30-minute intervention and 60-minute control study phases.

Eligibility
Key inclusion criteria
• Born at GA equal to or greater than 34 weeks
• Clinical decision that the baby should continue variable-flow CPAP therapy for the next 6 hours
• Infant is stable for >3 hours before 1 hour observation period on a variable-flow CPAP pressure between 4 and 10 cmH2O with FiO2 less than or equal to 0.3 oxygen requirement, with a respiratory rate of <70 breaths/min and without significant desaturation or bradycardia events (defined at spontaneous events with oxygen saturation levels < 80%, heart rate <100 beats/min and requiring nursing intervention).
• Infants will be discussed with the attending neonatologist as to their suitability relative to the study protocol on the morning ward round, and the ultimate discretion remains at all times with the neonatologist responsible for the infant’s care.
Minimum age
34 Weeks
Maximum age
200 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Infants with congenital abnormalities, suspected chromosomal abnormalities or other conditions which would exclude the use of variable-flow CPAP.
• Prenatal asphyxia (Apgar score less than 5 at minute 5, Cord pH less than 7, and Lactate > 6)
• Infants with notifiable diseases.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2023
Actual
15/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 25254 0
New Zealand
State/province [1] 25254 0
Christchurch

Funding & Sponsors
Funding source category [1] 313175 0
Commercial sector/Industry
Name [1] 313175 0
Fisher & Paykel Healthcare
Country [1] 313175 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland, 2013
New Zealand
Country
New Zealand
Secondary sponsor category [1] 314882 0
None
Name [1] 314882 0
Address [1] 314882 0
Country [1] 314882 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312414 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 312414 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington, 6011
New Zealand
Ethics committee country [1] 312414 0
New Zealand
Date submitted for ethics approval [1] 312414 0
Approval date [1] 312414 0
30/09/2022
Ethics approval number [1] 312414 0

Summary
Brief summary
The purpose of this clinical investigation is to compare the performance of a neonatal flow generator device (a new integrated flow source, oxygen blender, and heated-humidification system) to deliver variable-flow CPAP therapy in the Neonatal Intensive Care Unit (NICU) to spontaneously breathing infants requiring respiratory support. The trial objective will be to collect data to demonstrate that variable-flow CPAP delivered using the neonatal flow generator is non-inferior to the same therapy delivered using existing systems (SLE1000) in a sub-population in the NICU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124574 0
Dr Bronwyn Dixon
Address 124574 0
Matatiki Child & Youth Healthcare, Neonatal Service
Christchurch Women’s Hospital
Private Bag 4711
Christchurch, 8140
New Zealand
Country 124574 0
New Zealand
Phone 124574 0
+64 03 364 4008
Fax 124574 0
Email 124574 0
Bronwyn.Dixon@cdhb.health.nz
Contact person for public queries
Name 124575 0
Miss Caitlin Chatfield
Address 124575 0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland, 2013
New Zealand
Country 124575 0
New Zealand
Phone 124575 0
+64 212499434
Fax 124575 0
Email 124575 0
caitlin.chatfield@fphcare.co.nz
Contact person for scientific queries
Name 124576 0
Miss Caitlin Chatfield
Address 124576 0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland, 2013
New Zealand
Country 124576 0
New Zealand
Phone 124576 0
+64 212499434
Fax 124576 0
Email 124576 0
caitlin.chatfield@fphcare.co.nz

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


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.