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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-13
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-22
• Last Update Posted: 2016-07-25

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

Name	Time	Method
Deformation changes in nares of preterm infants that require ncpap	Up 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.

Trial Locations

Locations (1)

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