3D Imaging of Neonatal Faces

July 22, 2016 updated by: Anup Katheria, M.D., Sharp HealthCare

3D Imaging of Neonatal Subjects

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92123
        • Sharp Mary Birch Hospital for Women and Newborns

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants between 24 and 42 weeks corrected gestational age and admitted to Sharp Mary Birch NICU.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newborns requiring ncpap
3D scan of nares will be performed before and after administration of NCPAP for infants with Corrected Gestational Age greater than or equal to 24 weeks and less than or equal to 42 weeks.
3D scan of subjects nose prior to implementation of ncpap and upon discontinuation of ncpap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational Age at time of CPAP
Time Frame: Up to 6 months
Up to 6 months
Photograph of nose with scaled ruler
Time Frame: Up to 6 months
Up to 6 months
Initial 3D scan
Time Frame: Up to 6 months
Date & time of scan, head circumference, CGA, current weight, nasal integrity
Up to 6 months
Post ncpap 3D scan
Time Frame: Up to 6 months
Date & time of scan, head circumference, CGA, current weight, nasal integrity and/ or any notable distortion
Up to 6 months
Total duration of ncpap days
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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