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Trial registered on ANZCTR


Registration number
ACTRN12619000535178
Ethics application status
Approved
Date submitted
28/03/2019
Date registered
3/04/2019
Date last updated
3/04/2019
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two devices for breathing support in newborn babies
Scientific title
A single-centre, randomized, un-blinded, controlled, multi-period study
to assess the non-inferiority and safety of a neonatal flow generator to
deliver bubble CPAP to premature infants requiring respiratory
support.
Secondary ID [1] 297853 0
Nil known
Universal Trial Number (UTN)
U1111-1220-7070
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transient tachypnea of the newborn 312197 0
Premature birth 312226 0
Condition category
Condition code
Respiratory 310742 310742 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 310772 310772 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational device (neonatal flow generator) will be used to deliver flow and humidity for bubble continuous airway pressure (BCPAP) therapy to a neonate currently on BCPAP in the NICU. The investigational device will be compared to control device (F&P 950 setup) using un-blinded, 2-sequence, 2-treatment, 4-period, randomised cross-over design. The randomization sequence will be either ABBA or BAAB (A = control, B = investigational device). Each period will last 30-minutes. The flow and pressure setting on the investigation device will be set to match the therapy setting currently used on the neonate. The investigator will change between devices by disconnecting the inspiratory tube from the patient interface and connecting the inspiratory tube of the other device. The remainder of the setup for BCPAP therapy (i.e. patient interface, expiratory tube, bubbler) will remain unchanged when changing between the control and investigational devices.
Intervention code [1] 313175 0
Treatment: Devices
Comparator / control treatment
Bubble CPAP therapy as currently delivered in Middlemore NICU using the F&P 950 system. Typical settings for the therapy are flow rates of 4 to 15 L/min and set pressures of 3 to 10 cmH2O, Humidity is normally set to 37 degrees Celsius dew point.. See description of intervention for duration of control periods.
Control group
Active

Outcomes
Primary outcome [1] 308474 0
Difference in mean SpO2 level between intervention and control phases, as recorded from the pulse oximeter,
Timepoint [1] 308474 0
Mean SpO2 is averaged over the 30-minute intervention and control study phases
Secondary outcome [1] 355102 0
Difference in mean heart rate between intervention and control study phases, as recorded from the patient monitor.
Timepoint [1] 355102 0
Mean heart rate is averaged over the 30-minute intervention and control study phases
Secondary outcome [2] 355103 0
Difference in mean respiratory rate between intervention and control study phases, as recorded from the patient monitor.
Timepoint [2] 355103 0
Mean respiratory rate is averaged over the 30-minute intervention and control study phases
Secondary outcome [3] 355104 0
Adverse events that occur during the trial will be recorded as reported in medical records. These include nasal trauma, pulmonary air leaks, apnea, abdominal distension, intestinal perforation, necrotizing enterocolitis
Timepoint [3] 355104 0
Through out the four 30 minute intervention and control phases.

Eligibility
Key inclusion criteria
• Born at GA greater than or equal to 33 weeks
• Clinical decision that the baby should continue BCPAP therapy for the next 6 hours
• Infant is stable for >4 hours on a BCPAP pressure of 6 cmH2O and 6 L/min with no oxygen requirement, with a respiratory rate of <60 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
6 Hours
Maximum age
7 Weeks
Gender
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 BCPAP.
• Prenatal asphyxia (Apgar score less than 3 at minute 5, Cord pH less than 7, and cord bicarbonate less than 12)
• Infants with notifiable diseases.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21135 0
New Zealand
State/province [1] 21135 0
Auckland

Funding & Sponsors
Funding source category [1] 301473 0
Commercial sector/Industry
Name [1] 301473 0
Fisher & Paykel Healthcare
Address [1] 301473 0
15 Maurice Paykel Place
East Tamaki
Auckland, 2013
New Zealand
Country [1] 301473 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] 301165 0
None
Name [1] 301165 0
Address [1] 301165 0
Country [1] 301165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302218 0
Northern A HDEC
Ethics committee address [1] 302218 0
Ministry of Health
Health and Disability Ethics Committees
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 302218 0
New Zealand
Date submitted for ethics approval [1] 302218 0
15/10/2018
Approval date [1] 302218 0
07/12/2018
Ethics approval number [1] 302218 0
18/NTA/172

Summary
Brief summary
The purpose of this clinical investigation is to compare the performance of a flow generator to deliver bubble CPAP (BCPAP) therapy in the Neonatal Intensive Care Unit (NICU) to spontaneously breathing infants requiring respiratory support. The trial objective is to test if the flow generator system is non-inferior to the same therapy delivered using existing systems with respect to measured SpO2 in sub population of neonates who require BCPAP therapy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89482 0
Mr Jonathan Barrett
Address 89482 0
Middlemore Hospital, Hospital Road, Otahuhu, Auckland 2025
Country 89482 0
New Zealand
Phone 89482 0
+64 9 276 0171
Fax 89482 0
Email 89482 0
jrbarrett@middlemore.co.nz
Contact person for public queries
Name 89483 0
Dr James Revie
Address 89483 0
Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki
Auckland, 2013
Country 89483 0
New Zealand
Phone 89483 0
+64 9 574 0123 ext 7733
Fax 89483 0
Email 89483 0
james.revie@fphcare.co.nz
Contact person for scientific queries
Name 89484 0
Dr James Revie
Address 89484 0
Fisher & Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki
Auckland, 2013
Country 89484 0
New Zealand
Phone 89484 0
+64 9 574 0123 ext 7733
Fax 89484 0
Email 89484 0
james.revie@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 other documents available
Summary results
No Results