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Trial registered on ANZCTR


Registration number
ACTRN12623000156684
Ethics application status
Approved
Date submitted
28/01/2023
Date registered
16/02/2023
Date last updated
2/09/2024
Date data sharing statement initially provided
16/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Deep oropharyngeal air pressure measurements in newborns on non-invasive respiratory support (AIRPREMO Study)
Scientific title
Pharyngeal pressure measurements in newborn babies on continuous positive airway pressure or high flow nasal cannulae (AIRPREMO Study)
Secondary ID [1] 308808 0
None
Universal Trial Number (UTN)
U1111-1287-5937
Trial acronym
AIRPREMO (Airpressure Monitor) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome (RDS) Newborn
 328761 0
Newborn Lung Disease 328762 0
Condition category
Condition code
Respiratory 325773 325773 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 325974 325974 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In the AIRPREMO Study, a modified TGA approved dual lumen nasogastric tube (initially only 8 French in size; after participant 16, with Ethics Committee approval, either 6 French or 8 French in size, depending on the participant's weight and as per preference of the clinical team) is used to measure deep oropharyngeal air pressure of babies who receive non-invasive respiratory support (either through continuous positive airway pressure or through high flow nasal cannulae). Measurements are obtained with this research data collection system for up to one hour and data will inform the development of a new device.
Intervention code [1] 325259 0
Not applicable
Comparator / control treatment
The study does not have a control group. For participants on CPAP, the set CPAP pressures will be the comparator for the measured airway pressure and the comparisons will be processed over a total of up to one hour (rolling average). For high-flow participants, the measured pressures (rolling average) over one hour will be related to the set high flow rate.
Control group
Active

Outcomes
Primary outcome [1] 333664 0
For CPAP: Mean oropharyneal pressure [from the modified nasogastric tube] compared to the set pressure from CPAP.
Timepoint [1] 333664 0
At end of recording period (up to one hour)
Primary outcome [2] 333819 0
For high-flow: Mean oropharyneal pressure [from the modified nasogastric tube] compared to set high flow rate
Timepoint [2] 333819 0
At end of recording period (up to one hour)
Secondary outcome [1] 417887 0
User acceptability feedback from nursing staff observing the study intervention.
Timepoint [1] 417887 0
Completion of questionnaire (specifically designed for this study and HREC approved) at end of the one hour study period
Secondary outcome [2] 418423 0
Effects of newborn behavior (movement, crying etc) on observed oropharyngeal pressures. A variety of newborn behavious (such as movement, yawning, crying, etc.) will be recorded as timed log by the researcher.
Timepoint [2] 418423 0
End of one hour study period

Eligibility
Key inclusion criteria
Babies with a current weight of 1.5 kg or more treated at the Royal Women's Hospital Neonatal Intensive Care Unit receiving non-invasive respiratory support which is expected to be continued for at least one hour who are sufficiently stable for the study intervention as per assessment of the treating neonatal consultant
Minimum age
0 Days
Maximum age
1 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Weight less than 1.5 kg
Anatomical anomaly of the nose, mouth, palate, neck, nasal or pharyngeal airway

Study design
Purpose
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
As deep oropharyngeal pressures are measured over a one-hour period, the mean pressures will be determined. For CPAP, which has a set pressure, the mean pressure will be compared to the set pressure. For high flow the measured pressures will be correlated with the set flows. Pressure fluctuations will be correlated with a number of observed variables (bubbling, participant behaviours, movement etc). The range of measured pressures will be determined. As this is a proof-of-concept study, focus is on observations rather than formal statistical analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/02/2023
Actual
14/03/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
50
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23889 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 39366 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 313024 0
Other
Name [1] 313024 0
Graeme Clark HealthTech Innovation Challenge Grant
Country [1] 313024 0
Australia
Funding source category [2] 313072 0
Commercial sector/Industry
Name [2] 313072 0
Ventora Medical Pty Ltd
Country [2] 313072 0
Australia
Funding source category [3] 317312 0
Government body
Name [3] 317312 0
State of Victoria - Victorian Medical Research Acceleration Fund (Grant - Round 6)
Country [3] 317312 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
20 Flemington Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 314903 0
None
Name [1] 314903 0
Address [1] 314903 0
Country [1] 314903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312286 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 312286 0
Royal Women's Hospital
20 Flemington Road
Parkville VIC 3052
Ethics committee country [1] 312286 0
Australia
Date submitted for ethics approval [1] 312286 0
06/01/2021
Approval date [1] 312286 0
16/12/2022
Ethics approval number [1] 312286 0
HREC/72781/RWH-21-01

Summary
Brief summary
While continuous positive airway pressure (CPAP) and high flow nasal cannulae (HFNC) are commonly used for treatment of infants with respiratory distress, the optimum level of CPAP/HFNC remains somewhat uncertain. Due to leaks occurring at the nostrils, the mouth and into the stomach, not all of the pressure generated by CPAP/HFNC is transmitted to the airway. Real-time information of the patient’s pharyngeal pressure could provide clinicians with important information. The proposed research is a proof-of-concept observational study to measure the pharyngeal pressure in a convenience sample of 50 infants receiving CPAP/HFNC for the purpose of developing a novel airway pressure monitoring device.

TGA-approved dual lumen gastric tubes will be modified to allow for airway pressure measurements in the deep oropharynx using a new airway pressure device (under development). The modified gastric tube will be inserted nasally or orally, similar to regular gastric tubes, and pressures recorded over a one-hour period .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124110 0
A/Prof Christiane Theda
Address 124110 0
Royal Women's Hospital
Neonatal Services
20 Flemington Road
Parkville VIC 3128
Country 124110 0
Australia
Phone 124110 0
+61 03 8345 2671
Fax 124110 0
Email 124110 0
[email protected]
Contact person for public queries
Name 124111 0
Christiane Theda
Address 124111 0
Royal Women's Hospital
Neonatal Services
20 Flemington Road
Parkville VIC 3128
Country 124111 0
Australia
Phone 124111 0
+61 03 8345 2671
Fax 124111 0
Email 124111 0
[email protected]
Contact person for scientific queries
Name 124112 0
Christiane Theda
Address 124112 0
Royal Women's Hospital
Neonatal Services
20 Flemington Road
Parkville VIC 3128
Country 124112 0
Australia
Phone 124112 0
+61 03 8345 2671
Fax 124112 0
Email 124112 0
[email protected]

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.