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3D Imaging of Neonatal Faces

Completed
Conditions
Nose Deformities, Acquired
Registration Number
NCT02603796
Lead Sponsor
Sharp HealthCare
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Deformation changes in nares of preterm infants that require ncpapUp to 6 months

3D 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Sharp Mary Birch Hospital for Women and Newborns

🇺🇸

San Diego, California, United States

Sharp Mary Birch Hospital for Women and Newborns
🇺🇸San Diego, California, United States

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