Towards custom fitting continuous positive airway pressure (CPAP) devices for premature infants

Not Applicable

Completed

• Conditions: Prematurity; Bronchopulmonary dysplasia; CPAP complications; Reproductive Health and Childbirth - Complications of newborn; Respiratory - Other respiratory disorders / diseases; Public Health - Health service research

• Registration Number: ACTRN12622001045707
• Lead Sponsor: Metro North Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-28
• Study Completion: 2023-09-11
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: As soon as possible after starting CPAP therapy, up to the 3rd instance of CPAP initiation.<br>Timepoint 2: 14 days after the first scan or ceasing CPAP, whichever comes first.<br>]