Skip to content

Assessing the utility of 3D facial photography and sleep oximetry for Obstructive Sleep Apnoea severity in infants with Pierre Robin Sequence: A Pilot study

Diagnostic accuracy of 3D facial photography and sleep oximetry in assessing the severity of Obstructive Sleep Apnoea in infants with Pierre Robin Sequence: A Pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000863639
Acronym
ChIN-uP: (C) Capture facial photo and (IN) in NICU sleep study (uP) for PRS infants
Enrollment
2
Registered
2023-08-11
Start date
2023-06-06
Completion date
2028-12-31
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pierre Robin Sequence (PRS) is a rare (1:8500 live births) congenital condition characterized by micrognathia (small jaw)/retrognathia (receding chin), glossoptosis (posterior and upward displacement of the tongue) and upper airway obstruction. Many infants with PRS have a cleft of the soft palate. The main clinical issue for infants with PRS is upper airway obstruction (UAO) leading to obstructive sleep apnoea (OSA, intermittent brief cessations of breathing while asleep), feeding difficulties and failure to thrive (i.e. very slow weight gain). Polysomnography (PSG), also known as the sleep study is the currently approved tool to objectively assess the severity of OSA but is often difficult to obtain in a timely manner. This could lead to suboptimal care, prolonged hospital stays, parental anxiety, and staff dissatisfaction. Two other bedside tools, sleep pulse oximetry and 3D facial photography, are easier and quicker to perform and have the potential to diagnose OSA in these infants. However, there is currently limited evidence on their diagnostic accuracy in comparison to the gold-standard PSG in infants with PRS. Hence, we aim to conduct a prospective diagnostic accuracy study evaluating whether sleep pulse oximetry and 3D facial photography are non-inferior to PSG in detecting upper airway obstruction in infants with PRS. Additionally, we will explore the association between the severity of upper airway obstruction assessed using PSG, sleep pulse oximetry, and 3D facial photography with the neurodevelopmental outcomes of infants with PRS until two years of age. Given rarity of the disease, we aim to recruit for 4 years to reach a sample size of 30 with follow-up of each participant up to 2 years of corrected age. Data from study participants will be collected from birth to 24 months of life. The project is recruiting participants with rare conditions and syndromes.

Interventions

All infants diagnosed with Pierre Robin Sequence (PRS) admitted to Perth Children’s Hospital (PCH) NICU or referred to PCH outpatient clinic will be recruited after obtaining informed parental consent for 3D facial photography, sleep pulse oximetry and the Ages and Stages Questionnaire-Version 3 (ASQ-3). Polysomnography (PSG) will be simultaneously conducted as the standard care pathway for these infants for clinical management in NICU. The study involves taking two and three (2D and 3D) photo

All infants diagnosed with Pierre Robin Sequence (PRS) admitted to Perth Children’s Hospital (PCH) NICU or referred to PCH outpatient clinic will be recruited after obtaining informed parental consent for 3D facial photography, sleep pulse oximetry and the Ages and Stages Questionnaire-Version 3 (ASQ-3). Polysomnography (PSG) will be simultaneously conducted as the standard care pathway for these infants for clinical management in NICU. The study involves taking two and three (2D and 3D) photographs of your child’s face and conducting simultaneous sleep oximetry along with a standard sleep study/Polysomnography (PSG). Facial photography is like taking a photograph with your digital camera at home. All photographs will be taken after appropriate parental consent by the researcher or the clinical photographer at PCH. Two different camera systems may be used. The 2D cameras and/or the Vectra Handheld camera are used in the infant age group and 3dMD fixed system camera for older children. These are portable cameras, much like any digital SLR. Three successive facial images will be taken – right side, front on and left side. A computer automatically stitches these images into a 3D image. Older children may be asked to sit on a stool or their parent’s lap facing two sets of cameras housed in shoebox-size containers mounted to a portable stand. The actual image capture time is less than 2 milliseconds (3DMD camera) and approximately one minute for the Vectra camera. However, each scan may take up to 2- 5 minutes considering that several poses may be required. Time also needs to be allocated to check each scan. The whole process, including height and weight measurement and filling in the questionnaire takes no longer than 10 minutes. Sleep oximetry will be performed with standard devices used by respiratory and sleep departments at PCH. These include new generation devices Massimo or Nellcor™ bedside SpO2 patient monitoring systems which incorporate the latest digital signal processing technology to enable accurate and reliable readings even during low perfusion or other forms of signal interference and filtering of artefacts due to movements. Sleep oximetry will be conducted simultaneously with Polysomnography (PSG) by attaching the cutaneous sensor to the spare limb of the study participant. The sleep oximetry data will be downloaded and analysed using the standard software used by the respiratory and sleep departments. The report will be reviewed and analysed by the researcher under supervision of the sleep specialist. The time of sleep oximetry will be same as Polysomnography (PSG) and no additional time will be required. It will be performed every time the child needs a Polysomnography (PSG) for clinical reasons as prescribed by the treating clinician. ASQ-3™ (Ages and Stages Questionnaire) is a screening tool that meets the Australian standards for sensitivity and specificity and is endorsed for use by Community Health services in Western Australia. The ASQ-3™ can be used from 1 month until 66 months. It is a parent-completed questionnaire and consists of a series of questions screening for communication, gross motor, fine motor, problem solving, and personal adaptive skills. It provides a cut-off score in 5 domains of development. a) Red zone (i.e., ASQ score worse than 2SD below the mean) indicates the need for further evaluation and b) a monitoring zone (i.e., ASQ score worse than 1SD below the mean) identifies children who should be monitored and rescreened. The ASQ questionnaires will be sent to parents by post or email after informed consent and will be scored by the researcher on return. These can be completed by the parents/caregivers independently or with the assistance of professionals or administered by a trained professional. The data will be collected as per current standard practice of developmental follow-up at 4, 8, 12 and 24 months.

Sponsors

Perth Children's Hosptial
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
0 to 2 Years
Healthy volunteers
No

Inclusion criteria

All infants born with a clinical diagnosis of PRS and admitted to the NICU of PCH or referred to the PCH outpatient department in the first 2 years of life will be eligible for inclusion.

Exclusion criteria

Anyone wishing to participate will not be excluded from the study, but data from participants who have had radical facial trauma or who have undergone major face-altering surgery will not be included in the analysis.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026