Nose Deformities, AcquiredNCT02603796
3D Imaging of Neonatal Faces
An observational study of Nose Deformities, Acquired, run by Sharp HealthCare at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 24 to 42 weeks
- Conditions the study is for
- Nose Deformities, Acquired
- What is being tested?
- 3D Scan of nares
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants between 24 and 42 weeks corrected gestational age and admitted to Sharp Mary Birch NICU.
Who may be able to join
- Infants between 24 and 42 weeks corrected gestational age (inclusive) born at Sharp Mary Birch NICU,
- Signed informed consent form
Who cannot join
- Nasally intubated infants
- Infants with craniofacial abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
About this study
Official title: 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.
Read the 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.
- Conditions
- Nose Deformities, Acquired
- Being tested
- 3D Scan of nares
- Keywords
- 3-Dimensional, continuous positive airway pressure, nasal changes
- Medical subject headings
- Nose Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Scan of naresOther
3D scan of subjects nose prior to implementation of ncpap and upon discontinuation of ncpap.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 3D Scan of nares |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nose Deformities, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Anup Katheria, M.D., Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603796
- Sponsor's protocol ID
- 3D Imaging in neonates
- Status last verified
- Jul 2016
- First submitted
- 30 Oct 2015
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Imaging of Neonatal Subjects
- ClinicalTrials.gov ID
- NCT02603796
- Acronym / sponsor ID
- 3D Imaging in neonates
- Conditions
- Nose Deformities, Acquired
- Keywords
- 3-Dimensional, continuous positive airway pressure, nasal changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns requiring ncpap | – | Other: 3D Scan of nares3D 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. |
Who may qualify
- Ages
- 24 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants between 24 and 42 weeks corrected gestational age and admitted to Sharp Mary Birch NICU.
Key inclusion criteria (2 listed)
- Infants between 24 and 42 weeks corrected gestational age (inclusive) born at Sharp Mary Birch NICU,
- Signed informed consent form
Key exclusion criteria (2 listed)
- Nasally intubated infants
- Infants with craniofacial abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Scan of nares3D scan of subjects nose prior to implementation of ncpap and upon discontinuation of ncpap. | Other | Newborns requiring ncpap |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nose Deformities, Acquired, run by Sharp HealthCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deformation changes in nares of preterm infants that require ncpap (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.