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Clinical Trials/NCT02603796
NCT02603796
Completed
Not Applicable

3D Imaging of Neonatal Subjects

Sharp HealthCare1 site in 1 country18 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nose Deformities, Acquired
Sponsor
Sharp HealthCare
Enrollment
18
Locations
1
Primary Endpoint
Deformation changes in nares of preterm infants that require ncpap
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
June 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anup Katheria, M.D.

Director of Neonatal Research

Sharp HealthCare

Eligibility Criteria

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

Outcomes

Primary Outcomes

Deformation changes in nares of preterm infants that require ncpap

Time Frame: 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.

Study Sites (1)

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