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Trial registered on ANZCTR
Registration number
ACTRN12619000197134
Ethics application status
Approved
Date submitted
7/02/2019
Date registered
12/02/2019
Date last updated
17/10/2019
Date data sharing statement initially provided
12/02/2019
Date results information initially provided
17/10/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
An observational study of the gas flow delivered by bubble continuous positive airway pressure (CPAP) to preterm infants in neonatal intensive care
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Scientific title
An observational study of the gas flow delivered by bubble CPAP to preterm infants in neonatal intensive care
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Secondary ID [1]
297314
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None
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Universal Trial Number (UTN)
U1111-1228-0755
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome
311421
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Condition category
Condition code
Respiratory
310051
310051
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0
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Other respiratory disorders / diseases
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Reproductive Health and Childbirth
310052
310052
0
0
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Complications of newborn
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Preterm infants receiving bubble CPAP in the neonatal intensive care unit will have demographic information and weight recorded. The current state of the infant including flow rate, bCPAP pressure, mouth opening, and nasal prong fit will be recorded. The gas flow will then be adjusted until bubbling just ceases and the flow and pressure measurements will be repeated. The infant’s chin will then be gently supported to close the mouth, and the measurements taken for a third time. This will be recorded for 50 infants over the space of 3 months. It will take approximately 15 minutes to record each neonate.
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Intervention code [1]
313568
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
318951
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Gas flow in litres per minute delivered by bubble CPAP at a range of set pressures to the nose of preterm infants.
CPAP pressure will be monitored via a pressure monitor connected to the inspiratory limb of the system. Gas flow to the infant will be read from the flow meter in L/min once bubbling has ceased in the bubble chamber.
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Assessment method [1]
318951
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Timepoint [1]
318951
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At time of observation.
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Secondary outcome [1]
366521
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Gas flow changes in litres per minute with mouth opened or closed.
Gas flow to the infant will be read from the flow meter in L/min once bubbling has ceased in the bubble chamber. Mouth opening will be assessed as either open or closed by observation.
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Assessment method [1]
366521
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Timepoint [1]
366521
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At time of observation.
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Eligibility
Key inclusion criteria
- Infants born less than 37 weeks gestation.
- Currently receiving bubble CPAP therapy for any reason in the neonatal intensive care unit (NICU).
- Agreement from the treating clinician to include the infant in the study.
- Informed consent for participation in the study provided by the parent or guardian.
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Minimum age
No limit
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Maximum age
6
Months
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Informed consent refused or withdrawn by a parent or guardian.
- Unstable clinical condition, including but not limited to respiratory distress and varying oxygen saturation.
- Deemed unsuitable by the treating clinician for participation in the study.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
A convenience sample of 50 babies will be enrolled to the study. This provides 80% power to detect a 0.4 standard deviation difference between pressures of 5 and 8 mmH2O.
For the primary outcome, the data will be presented as the mean and standard deviations or median with interquartile range depending on the normality of the data. For the primary outcome only the first assessment will be used. A secondary analysis using all measurements from individual infants will be undertaken.
The effect of infant weight on the delivered flow will be determined by comparing mean (SD) flow of infants <1000g, 1000-1499g, 1500-2499g using ANOVA.
The effect of mouth closure will be determined using a paired t-test.
Demographic data will be descriptive and will be reported as means (standard deviations), medians (interquartile ranges), or proportions as appropriate.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
27/03/2019
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Actual
29/03/2019
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Date of last participant enrolment
Anticipated
31/08/2019
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Actual
10/09/2019
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Date of last data collection
Anticipated
31/08/2019
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Actual
11/09/2019
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Sample size
Target
50
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Accrual to date
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Final
44
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
13051
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The Royal Women's Hospital - Parkville
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Recruitment postcode(s) [1]
25557
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3052 - Parkville
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Funding & Sponsors
Funding source category [1]
301878
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Hospital
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Name [1]
301878
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Department of Newborn Research, The Royal Women's Hospital, Melbourne
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Address [1]
301878
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Level7,
20 Flemington Road
PARKVILLE VIC 3052
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Country [1]
301878
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Australia
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Primary sponsor type
Hospital
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Name
Department of Newborn Research, The Royal Women's Hospital Melbourne
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Address
Level 7,
20 Flemington Road
PARKVILLE VIC 3052
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Country
Australia
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Secondary sponsor category [1]
301631
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None
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Name [1]
301631
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Address [1]
301631
0
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Country [1]
301631
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302569
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The Royal Women's Hospital Human Research Ethics Committee
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Ethics committee address [1]
302569
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20 Flemington Road
PARKVILLE VIC 3052
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Ethics committee country [1]
302569
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Australia
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Date submitted for ethics approval [1]
302569
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16/01/2019
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Approval date [1]
302569
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19/03/2019
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Ethics approval number [1]
302569
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Summary
Brief summary
This is a single-centre observational study that aims to measure the gas flow delivered by bubble CPAP to preterm infants in neonatal intensive care. The project will aim to recruit 50 stable infants currently receiving bubble CPAP in the Royal Women’s Hospital Neonatal Intensive Care Unit. The data collection process involves: recording of the gas flow and pressure of the bubble CPAP apparatus at baseline; decreasing the gas flow until bubbling ceases whilst maintaining the CPAP pressure to record the gas flow being delivered to the infant; recording the gas flow with the infant’s mouth closed; after which the gas flow will be returned to its initial setting. This information will provide insight into the mechanism of action of bubble CPAP compared to other non-invasive respiratory supports such as Nasal High-flow Therapy (nHFT). We hypothesise that the gas flow produced in bubble CPAP is similar to that used in nHFT.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
90690
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Mr Cameron Payne
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Address
90690
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Newborn Research Centre, The Royal Women's Hospital, Melbourne
Level 7,
20 Flemington road
PARKVILLE VICTORIA 3052
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Country
90690
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Australia
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Phone
90690
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+61 3 84353763
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Fax
90690
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Email
90690
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[email protected]
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Contact person for public queries
Name
90691
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Mr Cameron Payne
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Address
90691
0
Newborn Research Centre, The Royal Women's Hospital, Melbourne
Level 7,
20 Flemington road
PARKVILLE VICTORIA 3052
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Country
90691
0
Australia
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Phone
90691
0
+61 3 84353763
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Fax
90691
0
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Email
90691
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[email protected]
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Contact person for scientific queries
Name
90692
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Mr Cameron Payne
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Address
90692
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Newborn Research Centre, The Royal Women's Hospital, Melbourne
Level 7,
20 Flemington road
PARKVILLE VICTORIA 3052
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Country
90692
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Australia
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Phone
90692
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+61 3 84353763
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Fax
90692
0
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Email
90692
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The data collected in this study will be used only for the purposes of this study. Pooled, de-identified results will also be published as a part of the study.
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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
Source
Title
Year of Publication
DOI
Embase
Gas flow in preterm infants treated with bubble CPAP: An observational study.
2021
https://dx.doi.org/10.1136/archdischild-2020-319337
N.B. These documents automatically identified may not have been verified by the study sponsor.
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