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3D Imaging of Neonatal Faces

3D Imaging of Neonatal Subjects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02603796
Enrollment
18
Registered
2015-11-13
Start date
2015-10-31
Completion date
2016-06-30
Last updated
2016-07-25

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

Conditions

Nose Deformities, Acquired

Keywords

3-Dimensional, continuous positive airway pressure, nasal changes

Brief summary

Facial scans of newborns will be performed before and after implementation of respiratory support devices such as nasal CPAP. 3D scanned images will be processed by Fisher & Paykel Healthcare Limited. Images will be analyzed for changes or distortion in nasal structure.

Detailed description

Any newborns admitted to the neonatal intensive care unit at Sharp Mary Birch Hospital for Women and Newborns between 24-42 weeks CGA with parental informed consent are eligible. 3D scanned image will be obtained prior to implementation of nasal support devices and after nasal support devices. Fisher & Paykel Healthcare Limited will analyze the 3D images and observations will be made for changes in nasal structure or distortion.

Interventions

OTHER3D Scan of nares

3D scan of subjects nose prior to implementation of ncpap and upon discontinuation of ncpap.

Sponsors

Fisher and Paykel Healthcare
CollaboratorINDUSTRY
Sharp HealthCare
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 42 Weeks
Healthy volunteers
No

Inclusion criteria

* Infants between 24 and 42 weeks corrected gestational age (inclusive) born at Sharp Mary Birch NICU, * Signed informed consent form

Exclusion criteria

* Nasally intubated infants * Infants with craniofacial abnormalities

Design outcomes

Primary

MeasureTime frameDescription
Deformation changes in nares of preterm infants that require ncpapUp to 6 months3D scans of infants face will be performed before implementation of NCPAP and a 3D scan will be performed after the NCPAP is discontinued and the images will be analyzed for changes in facial structures that might be due to NCPAP.

Other

MeasureTime frameDescription
Gestational Age at time of CPAPUp to 6 months
Photograph of nose with scaled rulerUp to 6 months
Initial 3D scanUp to 6 monthsDate & time of scan, head circumference, CGA, current weight, nasal integrity
Post ncpap 3D scanUp to 6 monthsDate & time of scan, head circumference, CGA, current weight, nasal integrity and/ or any notable distortion
Total duration of ncpap daysUp to 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026