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Trial registered on ANZCTR


Registration number
ACTRN12622001045707
Ethics application status
Approved
Date submitted
12/03/2022
Date registered
28/07/2022
Date last updated
30/08/2024
Date data sharing statement initially provided
28/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Towards custom fitting continuous positive airway pressure (CPAP) devices for premature infants
Scientific title
Using a 3D scanner to investigate nasal injuries from CPAP devices in premature infants.
Secondary ID [1] 306667 0
Nil known
Universal Trial Number (UTN)
Trial acronym
COMFIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 325604 0
Bronchopulmonary dysplasia 325605 0
CPAP complications 325606 0
Condition category
Condition code
Reproductive Health and Childbirth 322966 322966 0 0
Complications of newborn
Respiratory 323711 323711 0 0
Other respiratory disorders / diseases
Public Health 323712 323712 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A member of the clinical team will perform (up to 30 seconds) 3D facial scans on each participant, in the infant's cot, in the intensive care nursery. 3D facial scans will not affect participant treatment in any way. Scans will only occur during the baby's cares when the CPAP device is removed for short periods of time for cleaning and to inspect for injuries as part of routine care. CPAP will be reapplied between each scan. The first scan will occur as soon as possible after starting CPAP therapy and again at 14 days after starting CPAP. The scanner used to capture the data will be the most optimal 3D scanners, identified prior to this study. These scanners will be one of the 3D scanners selected from a pool of scanners [Artec Leo, ipad 12, Bellus, Revopoint or a photogrammetry custom made rig](to be decided in the preceding phase of the study, which involves identifying the optimal scanners using a manikin or 3D printed model (simulacrum)). Scanning personnel will be trained to perform clinical scans. All scans performed will be reviewed promptly by members of the research team, to ensure the image acquired is adequate for data collection.
Intervention code [1] 323109 0
Early detection / Screening
Comparator / control treatment
All premature infants will be scanned with the 3D scanner and assessed for face size, shape and presence of injuries. The facial features of those who are free from injury, acquire single facial injury, and acquire multiple facial injuries (and severity of injuries) will be compared.
Control group
Active

Outcomes
Primary outcome [1] 330732 0
Feasibility of 3D scanning of facial features of preterm infants on CPAP, including nostril size, nostril shape, nostril symmetry, septal (columella) width, bridge width or height, or distances between any of these landmarks, surface feature deviation analysis (voxel by voxel) by 3D scans. Feasibility of 3D scanning will be assessed through the scan quality and ability to visualise anatomical landmarks, measured on a rating scale by four independent assessors.
Timepoint [1] 330732 0
Timepoint 1: As soon as possible after starting CPAP therapy, up to the 3rd instance of CPAP initiation.
Timepoint 2: 14 days after the first scan or ceasing CPAP, whichever comes first.
Secondary outcome [1] 409963 0
Stage of nasal injury from CPAP device, measured by the stage of skin injury, will be assessed by the bedside nurse. Stage 0 - no injury, stage 1 - non-blanchable erythema, stage 2 - partial thickness skin loss (shallow ulcer), stage 3 - full thickness skin loss, stage 4 - full thickness tissue loss, stage 5 - unstageable, depth unknown.
Timepoint [1] 409963 0
At the time of the 3D facial scans - as soon as possible after starting CPAP therapy and at 14 days after starting CPAP or at CPAP completion, whichever occurs first.
Secondary outcome [2] 409964 0
Determine clinician acceptability of scanning. This will be determined by a short 3 question survey at the time of scanning, specifically designed for this study. Q1. 3D scanning did not adversely interfere with clinical care delivery (5 point likert scale - strongly disagree etc.), Q2. What changes were required to the neonatal care delivery area to complete scan? (Check box: room lighting, cot, mattress tilt, equipment, other...). Q3. I think 3D scanning and printing will improve the neonatal CPAP experience (5 point likert scale).
Timepoint [2] 409964 0
This will occur at the time of scanning by clinicians who are using or observing the 3D facial scans.
Secondary outcome [3] 409965 0
Duration of scans. This will be assessed at the time of each scan using the data collection form designed specifically for the study. The date and time at the start of scanning and at the end of scanning will be recorded.
Timepoint [3] 409965 0
This will occur at the time of 3D facial scanning.
Secondary outcome [4] 439262 0
3D scan facial features of preterm infants, including columella width
Timepoint [4] 439262 0
Cumulative data will be assessed at the conclusion of the data collection period.
Secondary outcome [5] 439263 0
3D scan facial features, including philtrum
Timepoint [5] 439263 0
Cumulative data will be assessed at the conclusion of the data collection period.
Secondary outcome [6] 439264 0
3D scan facial features, including philtrum
Timepoint [6] 439264 0
Cumulative data will be assessed at the conclusion of the data collection period.
Secondary outcome [7] 439265 0
3D scan facial features including upper lip
Timepoint [7] 439265 0
Cumulative data will be assessed at the conclusion of the data collection period.
Secondary outcome [8] 439266 0
3D scan facial features including upper lip
Timepoint [8] 439266 0
Cumulative data will be assessed at the conclusion of the data collection period.
Secondary outcome [9] 439267 0
3D scan facial features of preterm infants including lower lip
Timepoint [9] 439267 0
Cumulative data will be assessed at the conclusion of the data collection period.
Secondary outcome [10] 439268 0
3D scan facial features of preterm infants including lower lip
Timepoint [10] 439268 0
Cumulative data will be assessed at the conclusion of the data collection period.
Secondary outcome [11] 439269 0
3D scan facial features of preterm infants, including bridge width or height
Timepoint [11] 439269 0
Cumulative data will be assessed at the conclusion of the data collection period.
Secondary outcome [12] 439270 0
3D scan facial features of preterm infants, including bridge width or height
Timepoint [12] 439270 0
Cumulative data will be assessed at the conclusion of the data collection period.

Eligibility
Key inclusion criteria
Infants born <30 weeks gestation and/or <1250g who require CPAP therapy for at least 5 days or more.
Minimum age
6 Hours
Maximum age
5 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants born with a facial congenital abnormality or infants with a poor prognosis and who may require redirection of care (palliation). Infants who are on non-invasive intermittent positive pressure ventilation (NIPPV) or requiring >8cm CPAP or >40% oxygen, or who are deemed too unwell for handling at the time scan is due. Change made after

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A cohort of preterm infants who meet inclusion criteria and whose parents consent to participate, will be recruited as study participants. Recruitment will continue until at least 20 preterm infants with CPAP injuries and 20 preterm infants without CPAP injury have been recruited (maximum 40 infants). In order to give some indication of sample size, we calculate a sample size based on a conservative estimate of variation, in a well-studied anatomical measurement in preterm infants (head circumference at 28 weeks gestational age). In this case, we aim to find a significant difference in two relative distances between landmarks of 20% between groups in a population with a natural standard deviation in measurements of 20% (Cohen’s D = 1). This results in a sample size of n~40 (20 per group), at 80% power, when using exploratory Student’s t-tests and a correction for multiple comparisons based on the false discovery rate, at a level of significance of 0.05. Of note, recruitment will continue until 20 participants in each group, injured and uninjured are collected, as injury may be unknown at time of recruitment. Analysis will be exploratory and a number of anatomical measures will be compared between outcome groups. These measures include nostril size, and columella and septal width. We will also investigate a surface deviation analysis (voxel by voxel differences) between outcome groups by averaging 3D scans within groups. Demographics will be compared between using statistical hypothesis tests to ensure inter-group homogeneity. Anatomical measures of facial morphology will be compared between two outcome groups. Differences between groups will be analyzed using hypothesis testing (parametric on non-parametric tests selected based on the distribution of the recorded data). The null hypothesis is that facial features are not associated with facial injuries in preterm infants who receive CPAP treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2022
Actual
6/12/2022
Date of last participant enrolment
Anticipated
28/02/2023
Actual
11/09/2023
Date of last data collection
Anticipated
24/03/2023
Actual
11/09/2023
Sample size
Target
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21961 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 37055 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 310995 0
Charities/Societies/Foundations
Name [1] 310995 0
RBWH Foundation
Country [1] 310995 0
Australia
Primary sponsor type
Hospital
Name
Metro North Health
Address
Level 14, Block 7
Royal Brisbane & Women's Hospital
Herston, Qld, 4029
Country
Australia
Secondary sponsor category [1] 312309 0
None
Name [1] 312309 0
Address [1] 312309 0
Country [1] 312309 0
Other collaborator category [1] 282365 0
Other Collaborative groups
Name [1] 282365 0
Herston Biofabrication Institute
Address [1] 282365 0
Level 12, Block 7
Royal Brisbane & Women's Hospital
Herston Queensland 4029
Country [1] 282365 0
Australia
Other collaborator category [2] 282366 0
Other Collaborative groups
Name [2] 282366 0
Queensland Institute of Medical Research Berghofer
Address [2] 282366 0
300 Herston Rd,
Herston Qld 4029
Country [2] 282366 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310548 0
RBWH HREC
Ethics committee address [1] 310548 0
Level 2, Building 34
Butterfield St
Herston Qld 4029
Ethics committee country [1] 310548 0
Australia
Date submitted for ethics approval [1] 310548 0
16/02/2022
Approval date [1] 310548 0
26/04/2022
Ethics approval number [1] 310548 0
HREC/2021/QRBW/83811

Summary
Brief summary
Nasal continuous positive airway pressure (CPAP) is the most common method of respiratory support used in the care of preterm infants. Injury to the nose from nasal CPAP occurs frequently (25% of infants using CPAP), potentially causing permanent scarring and disfigurement. Infants most at risk, are those born < 30 weeks gestation and < 1250g. Current nasal interfaces for CPAP available in the Grantley Stable Neonatal Unit (GSNU), come in a limited number of sizes and do not fit all faces. 3D printed custom fitted CPAP masks hold promise for reducing the risk of nasal injury from CPAP in this vulnerable population. This study will gather preliminary data to determine the best 3D scanning technique, to identify facial features that predispose preterm infants to CPAP nasal injuries. This is the first step towards the development of custom fitted CPAP masks to be manufactured, in house, at Metro North’s Herston Biofabrication Institute (HBI).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118042 0
Dr Melissa Lai
Address 118042 0
Grantley Stable Neonatal Unit
Level 5, Ned Hanlon Building
Royal Brisbane & Women's Hospital
Butterfield St, Herston, Qld 4029
Country 118042 0
Australia
Phone 118042 0
+61 7 3646 8918
Fax 118042 0
+61 7 3646 5259
Email 118042 0
[email protected]
Contact person for public queries
Name 118043 0
Melissa Lai
Address 118043 0
Grantley Stable Neonatal Unit
Level 5, Ned Hanlon Building
Royal Brisbane & Women's Hospital
Butterfield St, Herston, Qld 4029
Country 118043 0
Australia
Phone 118043 0
+61 7 3646 8918
Fax 118043 0
+61 7 3646 5259
Email 118043 0
[email protected]
Contact person for scientific queries
Name 118044 0
Melissa Lai
Address 118044 0
Grantley Stable Neonatal Unit
Level 5, Ned Hanlon Building
Royal Brisbane & Women's Hospital
Butterfield St, Herston, Qld 4029
Country 118044 0
Australia
Phone 118044 0
+61 7 3646 8918
Fax 118044 0
+61 7 3646 5259
Email 118044 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.