Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001314516
Ethics application status
Approved
Date submitted
1/09/2024
Date registered
29/10/2024
Date last updated
29/10/2024
Date data sharing statement initially provided
29/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Airway pressure measurements in newborns on non-invasive respiratory support: a feasibility study (AIRPREMO 2 Study)
Scientific title
Pharyngeal pressure in newborns on non-invasive respiratory support: a feasibility study to assess a new airway pressure monitor (AIRPREMO 2 Feasibility Study)
Secondary ID [1] 312863 0
NIL
Universal Trial Number (UTN)
U1111-1312-7838
Trial acronym
AIRPREMO 2 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Newborn Lung Disease 334997 0
Respiratory Distress Syndrome (RDS) 334998 0
Condition category
Condition code
Respiratory 331511 331511 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 331512 331512 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the AIRPREMO 2 Study, a modified TGA-approved dual-lumen gastric tube connected to a new external device will be used to measure the upper airway pressure (pharyngeal pressure) in newborns receiving non-invasive respiratory support (continuous positive airway pressure (CPAP) or high flow nasal cannula (HF)). Once inserted, the sensor lumen of the study feeding tube will be connected to a study sensor module unit which is connected to the study data acquisition unit (airway pressure monitor) that is positioned at the bedside. Pharyngeal pressure measurements will be obtained with the research data collection system for 3-8 days, with the data obtained from the study informing the development of a new device. Clinical staff will not have the ability to view the airway pressure data on the data acquisition unit unless shown by the research team.
The primary feeding lumen of the gastric tube will enable study participants to be fed as per usual clinical guidelines and facilitate enteral fluids/medication delivery as clinically required. The duration of recoding can vary from 3 to 8 days as outlined in our research protocol and as per clinical practices for replacement of tubes. Enteral feeds for infants on respiratory support are administered intermittently and advance (in volume and frequency) as the infant’s tolerance of feeding increases.
Intervention code [1] 329401 0
Other interventions
Comparator / control treatment
This is a feasibility study to assess a new device with no 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 the duration of the recording period. For high-flow participants, the measured pressures (rolling average) will be related to the set high flow rate.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339256 0
Pharyngeal pressure.
Timepoint [1] 339256 0
At the end of recording period (3-8 days post commencement of the recording period).
Primary outcome [2] 339257 0
Safety.
Timepoint [2] 339257 0
At the end of recording period (3-8 days post commencement of the recording period).
Secondary outcome [1] 439286 0
Pharyngeal pressure for different HF/CPAP settings.
Timepoint [1] 439286 0
At the end of recording period (3-8 days post commencement of the recording period).
Secondary outcome [2] 439287 0
Consistency of pharyngeal pressure at unchanged settings.
Timepoint [2] 439287 0
At the end of recording period (3-8 days post commencement of the recording period).

Eligibility
Key inclusion criteria
Babies with a current weight of 1 kg or more treated at the Royal Women's Hospital Neonatal Intensive Care Unit receiving non-invasive respiratory support (CPAP or HF), requiring an orogastric or nasogastric feeding tube (for enteral feeding, gastric decompression and/or medication administration) and considered clinically appropriate for study enrolment as per the assessment of the treating neonatal consultant. Note: There will be a lead-in phase of the study, with the first 5 participants recruited weighing 1.5kg or more.
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 kg.
Concurrent study that prohibits participation.
Anatomical anomaly of the nose, mouth, palate, neck, nasal or pharyngeal airway.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As pharyngeal pressures are measured over a 3-8 day period, the mean pressures will be calculated from the raw pharyngeal pressure data after necessary data processing steps have been applied (calculated as a rolling average). 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 (eg. pressure/flow settings, type of patient interface, weight, age, participant behaviours, etc). The range of measured pressures will be determined. The data obtained from the study will be used for an assessment of the clinical utility of the device, enable further development of the device and guide the design of future research studies, rather than a formal statistical analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
14/01/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27054 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 43121 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 317306 0
Government body
Name [1] 317306 0
Clinical Translation and Commercialisation Medtech Grant. MTPConnect (funded by the Medical Research Future Fund (MRFF) from the Australian Government Department of Health and Aged Care)
Country [1] 317306 0
Australia
Funding source category [2] 317307 0
Commercial sector/Industry
Name [2] 317307 0
Ventora Medical Pty Ltd
Country [2] 317307 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319587 0
None
Name [1] 319587 0
Address [1] 319587 0
Country [1] 319587 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316036 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 316036 0
Ethics committee country [1] 316036 0
Australia
Date submitted for ethics approval [1] 316036 0
06/03/2024
Approval date [1] 316036 0
24/04/2024
Ethics approval number [1] 316036 0
ERM 106742 RWH 24/10

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136582 0
A/Prof Christiane Theda
Address 136582 0
Royal Women's Hospital, Neonatal Services, 20 Flemington Road, Parkville VIC 3052.
Country 136582 0
Australia
Phone 136582 0
+61 03 8345 2671
Fax 136582 0
Email 136582 0
[email protected]
Contact person for public queries
Name 136583 0
Christiane Theda
Address 136583 0
Royal Women's Hospital, Neonatal Services, 20 Flemington Road, Parkville VIC 3052.
Country 136583 0
Australia
Phone 136583 0
+61 03 8345 2671
Fax 136583 0
Email 136583 0
[email protected]
Contact person for scientific queries
Name 136584 0
Christiane Theda
Address 136584 0
Royal Women's Hospital, Neonatal Services, 20 Flemington Road, Parkville VIC 3052.
Country 136584 0
Australia
Phone 136584 0
+61 03 8345 2671
Fax 136584 0
Email 136584 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
Only summarised data will be available for sharing/publication.


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.