Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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.
Query!
Secondary ID [1]
308963
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Premature birth
328978
0
Query!
Respiratory disease
329034
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
325961
325961
0
0
Query!
Complications of newborn
Query!
Respiratory
325962
325962
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
325409
0
Treatment: Devices
Query!
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.
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
333808
0
Query!
Timepoint [1]
333808
0
Mean SpO2 is averaged over the 30-minute intervention and 60-minute control study phases
Query!
Secondary outcome [1]
418363
0
Difference in mean heart rate between intervention and control study phases, as recorded from the patient monitor
Query!
Assessment method [1]
418363
0
Query!
Timepoint [1]
418363
0
Mean heart rate is averaged over the 30-minute intervention and 60-minute control study phases.
Query!
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.
Query!
Assessment method [2]
418364
0
Query!
Timepoint [2]
418364
0
Throughout the 4.5 hour observation period (includes all intervention and control phases).
Query!
Secondary outcome [3]
418751
0
Difference in mean respiratory rate between intervention and control study phases, as recorded from the patient monitor
Query!
Assessment method [3]
418751
0
Query!
Timepoint [3]
418751
0
.Mean respiratory rate is averaged over the 30-minute intervention and 60-minute control study phases.
Query!
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.
Query!
Minimum age
34
Weeks
Query!
Query!
Maximum age
200
Days
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
31/03/2023
Query!
Actual
15/08/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
15
Query!
Accrual to date
5
Query!
Final
Query!
Recruitment outside Australia
Country [1]
25254
0
New Zealand
Query!
State/province [1]
25254
0
Christchurch
Query!
Funding & Sponsors
Funding source category [1]
313175
0
Commercial sector/Industry
Query!
Name [1]
313175
0
Fisher & Paykel Healthcare
Query!
Address [1]
313175
0
15 Maurice Paykel Place
East Tamaki
Auckland, 2013
New Zealand
Query!
Country [1]
313175
0
New Zealand
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
Fisher & Paykel Healthcare
Query!
Address
15 Maurice Paykel Place
East Tamaki
Auckland, 2013
New Zealand
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
314882
0
None
Query!
Name [1]
314882
0
Query!
Address [1]
314882
0
Query!
Country [1]
314882
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
312414
0
Northern A Health and Disability Ethics Committee
Query!
Ethics committee address [1]
312414
0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington, 6011
New Zealand
Query!
Ethics committee country [1]
312414
0
New Zealand
Query!
Date submitted for ethics approval [1]
312414
0
Query!
Approval date [1]
312414
0
30/09/2022
Query!
Ethics approval number [1]
312414
0
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
124574
0
Dr Bronwyn Dixon
Query!
Address
124574
0
Matatiki Child & Youth Healthcare, Neonatal Service
Christchurch Women’s Hospital
Private Bag 4711
Christchurch, 8140
New Zealand
Query!
Country
124574
0
New Zealand
Query!
Phone
124574
0
+64 03 364 4008
Query!
Fax
124574
0
Query!
Email
124574
0
[email protected]
Query!
Contact person for public queries
Name
124575
0
Miss Caitlin Chatfield
Query!
Address
124575
0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland, 2013
New Zealand
Query!
Country
124575
0
New Zealand
Query!
Phone
124575
0
+64 212499434
Query!
Fax
124575
0
Query!
Email
124575
0
[email protected]
Query!
Contact person for scientific queries
Name
124576
0
Miss Caitlin Chatfield
Query!
Address
124576
0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland, 2013
New Zealand
Query!
Country
124576
0
New Zealand
Query!
Phone
124576
0
+64 212499434
Query!
Fax
124576
0
Query!
Email
124576
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF