- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02603796
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
Conditions
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
-
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California
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San Diego, California, United States, 92123
- Sharp Mary Birch Hospital for Women and Newborns
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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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3D Imaging in neonates
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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