None listed
Conditions
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).
Interventions
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 t
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.
Sponsors
Metro North Health
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
6 Hours to 5 Months
Healthy volunteers
No
Inclusion criteria
Infants born <30 weeks gestation and/or <1250g who require CPAP therapy for at least 5 days or more.
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
Outcome results
None listed