3D Imaging of Neonatal Faces

Nose Deformities, Acquired Clinical Trial

Official title:

3D Imaging of Neonatal Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603796
• Other study ID #: 3D Imaging in neonates
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: July 22, 2016
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 42 Weeks

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Abnormalities
• Nose Deformities, Acquired

Intervention

Other:
• 3D Scan of nares
3D scan of subjects nose prior to implementation of ncpap and upon discontinuation of ncpap.

Locations

Country	Name	City	State
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Sharp HealthCare	Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gestational Age at time of CPAP		Up to 6 months	No
Other	Photograph of nose with scaled ruler		Up to 6 months	No
Other	Initial 3D scan	Date & time of scan, head circumference, CGA, current weight, nasal integrity	Up to 6 months	No
Other	Post ncpap 3D scan	Date & time of scan, head circumference, CGA, current weight, nasal integrity and/ or any notable distortion	Up to 6 months	No
Other	Total duration of ncpap days		Up to 6 months	No
Primary	Deformation changes in nares of preterm infants that require ncpap	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.	Up to 6 months	No