Development, InfantNCT05004597
3D Craniofacial Morphologic Development of Healthy Infants
A study testing three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA) in people with Development, Infant and IMAGE, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Healthy infants were enrolled to receive three dimensional craniofacial photography regularly at their age of one month, two month, four month, six month, nine month and twelve month. All the image data was analyzed to reveal infants' craniofacial development. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Development, Infant, IMAGE, Craniofacial Asymmetry
- What is being tested?
- three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Dec 2018to 4 Nov 2020
- Phase
- Interventional
- 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 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Asian ethnicity
- healthy infants
- full-term
Who cannot join
- growth curve <3%
- premature
- congenital craniofacial anomaly
- hormonal anomaly.
- chromsomal anomaly
- thyroid anomaly
- bone anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-dimensional Normative Craniofacial Morphologic Development of Healthy Infants During the First Year of Life
Healthy infants were enrolled to receive three dimensional craniofacial photography regularly at their age of one month, two month, four month, six month, nine month and twelve month. All the image data was analyzed to reveal infants' craniofacial development.
Read the detailed description
Importance The development of craniofacial morphology in the first year of life is critical, especially when analyzed with longitudinal 3-dimensional photographs.
Objective To evaluate the development of the craniofacial region in healthy infants in the first year of life and provide treatment guidelines for craniofacial deformities such as orofacial clefts and deformational plagiocephaly.
Design, Setting, and Participants Three-dimensional (3D) photographs of included participants were captured using a 3dMD system. Participants were grouped by sex and age (1, 2, 4, 6, 9, and 12 months). We placed 32 craniofacial anatomical landmarks on 3D craniofacial photos. The thin-plate spline algorithm and closest-point matching were applied to transform a symmetric 3D template into a series of scanned images to calculate 3D composite heads at different ages.
Main Outcomes and Measures Average craniofacial meshes were calculated for each group. The growth patterns of the following anthropometric indices were determined: craniofacial height, depth, width, volume, body height, weight, body mass index (BMI), and head circumference.
- Conditions
- Development, Infant, IMAGE, Craniofacial Asymmetry, Plagiocephaly
- Being tested
- three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)
- Keywords
- craniofacial development, growth chart
- Medical subject headings
- Plagiocephaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)Other
A series of 3D craniofacial photos were captured using a 3dMDHead System (3dMD, Atlanta, GA, USA) within 7 days before or after the age of 1, 2, 4, 6, 9, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| infants longitudinally received three dimensional photo | Experimental | A series of 3D craniofacial photos were captured using a 3dMDHead System (3dMD, Atlanta, GA, USA) within 7 days before or after the age of 1, 2, 4, 6, 9, and 12 months Receives: Other: three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
craniofacial height
measurement of craniofacial anthropometry
Measured: at infants' age of 1 month-old
craniofacial height
measurement of craniofacial anthropometry
Measured: at infants' age of 2 month-old
craniofacial height
measurement of craniofacial anthropometry
Measured: at infants' age of 4 month-old
craniofacial height
measurement of craniofacial anthropometry
Measured: at infants' age of 6 month-old
craniofacial height
measurement of craniofacial anthropometry
Measured: at infants' age of 9 month-old
craniofacial height
measurement of craniofacial anthropometry
Measured: at infants' age of 12 month-old
craniofacial depth
measurement of craniofacial anthropometry
Measured: at infants' age of 1 month-old
craniofacial depth
measurement of craniofacial anthropometry
Measured: at infants' age of 2 month-old
craniofacial depth
measurement of craniofacial anthropometry
Measured: at infants' age of 4 month-old
craniofacial depth
measurement of craniofacial anthropometry
Measured: at infants' age of 6 month-old
craniofacial depth
measurement of craniofacial anthropometry
Measured: at infants' age of 9 month-old
craniofacial depth
measurement of craniofacial anthropometry
Measured: at infants' age of 12 month-old
craniofacial width
measurement of craniofacial anthropometry
Measured: at infants' age of 1 month-old
craniofacial width
measurement of craniofacial anthropometry
Measured: at infants' age of 2 month-old
craniofacial width
measurement of craniofacial anthropometry
Measured: at infants' age of 4 month-old
craniofacial width
measurement of craniofacial anthropometry
Measured: at infants' age of 6 month-old
craniofacial width
measurement of craniofacial anthropometry
Measured: at infants' age of 9 month-old
craniofacial width
measurement of craniofacial anthropometry
Measured: at infants' age of 12 month-old
craniofacial volume
measurement of craniofacial anthropometry
Measured: at infants' age of 1 month-old
craniofacial volume
measurement of craniofacial anthropometry
Measured: at infants' age of 2 month-old
craniofacial volume
measurement of craniofacial anthropometry
Measured: at infants' age of 4 month-old
craniofacial volume
measurement of craniofacial anthropometry
Measured: at infants' age of 6 month-old
craniofacial volume
measurement of craniofacial anthropometry
Measured: at infants' age of 9 month-old
craniofacial volume
measurement of craniofacial anthropometry
Measured: at infants' age of 12 month-old
body weight
measurement of craniofacial anthropometry
Measured: at infants' age of 1 month-old
body weight
measurement of craniofacial anthropometry
Measured: at infants' age of 2 month-old
body weight
measurement of craniofacial anthropometry
Measured: at infants' age of 4 month-old
body weight
measurement of craniofacial anthropometry
Measured: at infants' age of 6 month-old
body weight
measurement of craniofacial anthropometry
Measured: at infants' age of 9 month-old
body weight
measurement of craniofacial anthropometry
Measured: at infants' age of 12 month-old
body height
measurement of craniofacial anthropometry
Measured: at infants' age of 1 month-old
body height
measurement of craniofacial anthropometry
Measured: at infants' age of 2 month-old
body height
measurement of craniofacial anthropometry
Measured: at infants' age of 4 month-old
body height
measurement of craniofacial anthropometry
Measured: at infants' age of 6 month-old
body height
measurement of craniofacial anthropometry
Measured: at infants' age of 9 month-old
body height
measurement of craniofacial anthropometry
Measured: at infants' age of 12 month-old
body mass index (BMI)
measurement of craniofacial anthropometry
Measured: at infants' age of 1 month-old
body mass index (BMI)
measurement of craniofacial anthropometry
Measured: at infants' age of 2 month-old
body mass index (BMI)
measurement of craniofacial anthropometry
Measured: at infants' age of 4 month-old
body mass index (BMI)
measurement of craniofacial anthropometry
Measured: at infants' age of 6 month-old
body mass index (BMI)
measurement of craniofacial anthropometry
Measured: at infants' age of 9 month-old
body mass index (BMI)
measurement of craniofacial anthropometry
Measured: at infants' age of 12 month-old
head circumference
measurement of craniofacial anthropometry
Measured: at infants' age of 1 month-old
head circumference
measurement of craniofacial anthropometry
Measured: at infants' age of 2 month-old
head circumference
measurement of craniofacial anthropometry
Measured: at infants' age of 4 month-old
head circumference
measurement of craniofacial anthropometry
Measured: at infants' age of 6 month-old
head circumference
measurement of craniofacial anthropometry
Measured: at infants' age of 9 month-old
head circumference
measurement of craniofacial anthropometry
Measured: at infants' age of 12 month-old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start4 Dec 2018
- Primary completion27 Oct 2020
- Study completion4 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development, InfantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all subjects longitudinally received 3D image
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pangyunchou, Chang Gung Memorial Hospital
- Investigators
- Pangyun Chou, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004597
- Sponsor's protocol ID
- 201701939B0
- Status last verified
- Aug 2021
- First submitted
- 28 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: three dimensional photo acquisition for newborns
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Normative Craniofacial Morphologic Development of Healthy Infants During the First Year of Life
- ClinicalTrials.gov ID
- NCT05004597
- Acronym / sponsor ID
- 201701939B0
- Conditions
- Development, Infant, IMAGE, Craniofacial Asymmetry, Plagiocephaly
- Keywords
- craniofacial development, growth chart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 13 Aug 2021 (actual)
- 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.
Healthy infants were enrolled to receive three dimensional craniofacial photography regularly at their age of one month, two month, four month, six month, nine month and twelve month. All the image data was analyzed to reveal infants' craniofacial development.
Detailed description
Importance The development of craniofacial morphology in the first year of life is critical, especially when analyzed with longitudinal 3-dimensional photographs.
Objective To evaluate the development of the craniofacial region in healthy infants in the first year of life and provide treatment guidelines for craniofacial deformities such as orofacial clefts and deformational plagiocephaly.
Design, Setting, and Participants Three-dimensional (3D) photographs of included participants were captured using a 3dMD system. Participants were grouped by sex and age (1, 2, 4, 6, 9, and 12 months). We placed 32 craniofacial anatomical landmarks on 3D craniofacial photos. The thin-plate spline algorithm and closest-point matching were applied to transform a symmetric 3D template into a series of scanned images to calculate 3D composite heads at different ages.
Main Outcomes and Measures Average craniofacial meshes were calculated for each group. The growth patterns of the following anthropometric indices were determined: craniofacial height, depth, width, volume, body height, weight, body mass index (BMI), and head circumference.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all subjects longitudinally received 3D image
| Arm | Type | Receives |
|---|---|---|
| infants longitudinally received three dimensional photo | Experimental | Other: three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)A series of 3D craniofacial photos were captured using a 3dMDHead System (3dMD, Atlanta, GA, USA) within 7 days before or after the age of 1, 2, 4, 6, 9, and 12 months |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Asian ethnicity
- healthy infants
- full-term
Key exclusion criteria (7 listed)
- growth curve <3%
- premature
- congenital craniofacial anomaly
- hormonal anomaly.
- chromsomal anomaly
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 |
|---|---|---|
| three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)A series of 3D craniofacial photos were captured using a 3dMDHead System (3dMD, Atlanta, GA, USA) within 7 days before or after the age of 1, 2, 4, 6, 9, and 12 months. | Other | infants longitudinally received three dimensional photo |
Primary outcome
craniofacial height
Time frame: at infants' age of 1 month-old
measurement of craniofacial anthropometry
craniofacial height
Time frame: at infants' age of 2 month-old
measurement of craniofacial anthropometry
craniofacial height
Time frame: at infants' age of 4 month-old
measurement of craniofacial anthropometry
craniofacial height
Time frame: at infants' age of 6 month-old
measurement of craniofacial anthropometry
craniofacial height
Time frame: at infants' age of 9 month-old
measurement of craniofacial anthropometry
craniofacial height
Time frame: at infants' age of 12 month-old
measurement of craniofacial anthropometry
craniofacial depth
Time frame: at infants' age of 1 month-old
measurement of craniofacial anthropometry
craniofacial depth
Time frame: at infants' age of 2 month-old
measurement of craniofacial anthropometry
craniofacial depth
Time frame: at infants' age of 4 month-old
measurement of craniofacial anthropometry
craniofacial depth
Time frame: at infants' age of 6 month-old
measurement of craniofacial anthropometry
craniofacial depth
Time frame: at infants' age of 9 month-old
measurement of craniofacial anthropometry
craniofacial depth
Time frame: at infants' age of 12 month-old
measurement of craniofacial anthropometry
craniofacial width
Time frame: at infants' age of 1 month-old
measurement of craniofacial anthropometry
craniofacial width
Time frame: at infants' age of 2 month-old
measurement of craniofacial anthropometry
craniofacial width
Time frame: at infants' age of 4 month-old
measurement of craniofacial anthropometry
craniofacial width
Time frame: at infants' age of 6 month-old
measurement of craniofacial anthropometry
craniofacial width
Time frame: at infants' age of 9 month-old
measurement of craniofacial anthropometry
craniofacial width
Time frame: at infants' age of 12 month-old
measurement of craniofacial anthropometry
craniofacial volume
Time frame: at infants' age of 1 month-old
measurement of craniofacial anthropometry
craniofacial volume
Time frame: at infants' age of 2 month-old
measurement of craniofacial anthropometry
craniofacial volume
Time frame: at infants' age of 4 month-old
measurement of craniofacial anthropometry
craniofacial volume
Time frame: at infants' age of 6 month-old
measurement of craniofacial anthropometry
craniofacial volume
Time frame: at infants' age of 9 month-old
measurement of craniofacial anthropometry
craniofacial volume
Time frame: at infants' age of 12 month-old
measurement of craniofacial anthropometry
body weight
Time frame: at infants' age of 1 month-old
measurement of craniofacial anthropometry
body weight
Time frame: at infants' age of 2 month-old
measurement of craniofacial anthropometry
body weight
Time frame: at infants' age of 4 month-old
measurement of craniofacial anthropometry
body weight
Time frame: at infants' age of 6 month-old
measurement of craniofacial anthropometry
body weight
Time frame: at infants' age of 9 month-old
measurement of craniofacial anthropometry
body weight
Time frame: at infants' age of 12 month-old
measurement of craniofacial anthropometry
body height
Time frame: at infants' age of 1 month-old
measurement of craniofacial anthropometry
body height
Time frame: at infants' age of 2 month-old
measurement of craniofacial anthropometry
body height
Time frame: at infants' age of 4 month-old
measurement of craniofacial anthropometry
body height
Time frame: at infants' age of 6 month-old
measurement of craniofacial anthropometry
body height
Time frame: at infants' age of 9 month-old
measurement of craniofacial anthropometry
body height
Time frame: at infants' age of 12 month-old
measurement of craniofacial anthropometry
body mass index (BMI)
Time frame: at infants' age of 1 month-old
measurement of craniofacial anthropometry
body mass index (BMI)
Time frame: at infants' age of 2 month-old
measurement of craniofacial anthropometry
body mass index (BMI)
Time frame: at infants' age of 4 month-old
measurement of craniofacial anthropometry
body mass index (BMI)
Time frame: at infants' age of 6 month-old
measurement of craniofacial anthropometry
body mass index (BMI)
Time frame: at infants' age of 9 month-old
measurement of craniofacial anthropometry
body mass index (BMI)
Time frame: at infants' age of 12 month-old
measurement of craniofacial anthropometry
head circumference
Time frame: at infants' age of 1 month-old
measurement of craniofacial anthropometry
head circumference
Time frame: at infants' age of 2 month-old
measurement of craniofacial anthropometry
head circumference
Time frame: at infants' age of 4 month-old
measurement of craniofacial anthropometry
head circumference
Time frame: at infants' age of 6 month-old
measurement of craniofacial anthropometry
head circumference
Time frame: at infants' age of 9 month-old
measurement of craniofacial anthropometry
head circumference
Time frame: at infants' age of 12 month-old
measurement of craniofacial anthropometry
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 13 Aug 2021.
- Individual participant dataSharing planned: No. three dimensional photo acquisition for newborns
Related trials for Development, Infant
Recruiting
Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
Gut Microbiome, Neurocognitive Correlates of Eating Habits
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Active, not recruitingPhase 2
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Tuberous Sclerosis Complex, Epilepsy
RecruitingObservational study
Impact of Delivery Mode on Infant Gut Microbiota, Visceral Sensitivity, and the Neuroenteric System
Healthy Newborn Infants
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.
Pangyun Chou, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA) in people with Development, Infant and IMAGE, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 7 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 13 Aug 2021. 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 Taiwan. 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?
craniofacial height (time frame: at infants' age of 1 month-old). The study lists 48 primary outcomes in all. 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 13 Aug 2021.