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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
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Backup rate selection during neonatal assist control volume guarantee ventilation: A randomised crossover trial
Scientific title
Backup rate selection during neonatal assist control volume guarantee ventilation: A randomised crossover trial
Secondary ID [1] 252877 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal ventilation 258408 0
Condition category
Condition code
Respiratory 258574 258574 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 258611 258611 0 0
Complications of newborn

Study type
Description of intervention(s) / exposure
Ventilator back-up rates 30, 40 and 50 /min will be compared in random order. The intervention periods (epochs) will last for 20 mins. Each epoch will be preceded by a 10 minute washout period. Infants will be ventilated using assist control volume guarantee mode with the Drager Babylog 8000plus ventilator throughout the study
Intervention code [1] 257404 0
Treatment: Devices
Comparator / control treatment
See description of interventions
Control group

Primary outcome [1] 259420 0
Proportion of ventilator inflations triggered by the the infant identified from the ventilator waveforms/trigger data
Timepoint [1] 259420 0
These data are measured continually. The outcome is defined as the number of triggered inflations / total number of inflations over the epoch
Secondary outcome [1] 265966 0
Ventilator parameters determined from the ventilator data including:
Rate, mean airway pressure, peak inflating pressure
Timepoint [1] 265966 0
The data are measure continually over the epoch. Epoch averages will be compared
Secondary outcome [2] 265967 0
Measures of cardiorespiratory stability including:
FiO2, SpO2, TcCO2, HR and BP assessed using the ventilator data, Masimo Radical pulse oximeter, and Philips Intellivue series monitor with transcutaneous module
Timepoint [2] 265967 0
These data are recorded every minute. The change over the epoch will be measured (average data from last 2 mins of epoch minus average data from last 2 mins of run in period prior to epoch)

Key inclusion criteria
Stable ventilated infants, ventilated using assist control volume guarantee (AC/VG) for previous 24 hours.
Minimum age
24 Hours
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Ventilator changes in previous 4 hours, pH < 7.2, pCO2>80 mmHg, FiO2 > 0.8, acute pneumothoax/pulmonary interstitial emphysema, significant congenital abnormality, severe PVH, receiving muscle relaxants or morphine infusion > 20 ug/kg/hr

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised crossover trial.
Allocation of order of interventions using sequentially numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

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

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257842 0
Government body
Name [1] 257842 0
Address [1] 257842 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 257842 0
Primary sponsor type
Royal Women's Hospital
Locked Bag 300
Cnr Grattan Street/Flemington Road
Vic 3052
Secondary sponsor category [1] 257049 0
Name [1] 257049 0
Address [1] 257049 0
Country [1] 257049 0

Ethics approval
Ethics application status
Ethics committee name [1] 259878 0
The Royal Womens Hospital Research and Ethics Committees
Ethics committee address [1] 259878 0
Locked Bag 300
Cnr Grattan St/Flemington Road
Vic 3052
Ethics committee country [1] 259878 0
Date submitted for ethics approval [1] 259878 0
Approval date [1] 259878 0
Ethics approval number [1] 259878 0
Project 07/33

Brief summary
The purpose of this project is to study how ventilators (breathing machines) support babies. We are investigating how we use the ventilator with the aim of better matching the babies' natural breathing patterns. The backup rate is the speed at which the ventilator works if your baby does not breathe fast enough. Previous experience has suggests that higher backup rates do not give your baby as much chance to breathe for themselves. Slower backup rates give your baby more change to breathe naturally, but when the ventilator takes over it works more slowly.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 31776 0
Address 31776 0
Country 31776 0
Phone 31776 0
Fax 31776 0
Email 31776 0
Contact person for public queries
Name 15023 0
Kevin Wheeler
Address 15023 0
Newborn Research
Royal Women's Hospital
Locked Bag 300
Cnr Grattan Street/Flemington Road
Vic 3052
Country 15023 0
Phone 15023 0
+61 3 8345 2000
Fax 15023 0
Email 15023 0
Contact person for scientific queries
Name 5951 0
Kevin Wheeler
Address 5951 0
Newborn Research
Royal Women's Hospital
Locked Bag 300
Cnr Grattan Street/Flemington Road
Vic 3052
Country 5951 0
Phone 5951 0
+61 3 8345 2000
Fax 5951 0
Email 5951 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary