3D Craniofacial Morphologic Development of Healthy Infants
Primary Purpose
Development, Infant, IMAGE, Craniofacial Asymmetry
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)
Sponsored by
About this trial
This is an interventional health services research trial for Development, Infant focused on measuring craniofacial development, growth chart
Eligibility Criteria
Inclusion Criteria:
- Asian ethnicity
- healthy infants
- full-term
Exclusion Criteria:
- growth curve <3%
- premature
- congenital craniofacial anomaly
- hormonal anomaly.
- chromsomal anomaly
- thyroid anomaly
- bone anomaly
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
infants longitudinally received three dimensional photo
Arm Description
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
Outcomes
Primary Outcome Measures
craniofacial height
measurement of craniofacial anthropometry
craniofacial height
measurement of craniofacial anthropometry
craniofacial height
measurement of craniofacial anthropometry
craniofacial height
measurement of craniofacial anthropometry
craniofacial height
measurement of craniofacial anthropometry
craniofacial height
measurement of craniofacial anthropometry
craniofacial depth
measurement of craniofacial anthropometry
craniofacial depth
measurement of craniofacial anthropometry
craniofacial depth
measurement of craniofacial anthropometry
craniofacial depth
measurement of craniofacial anthropometry
craniofacial depth
measurement of craniofacial anthropometry
craniofacial depth
measurement of craniofacial anthropometry
craniofacial width
measurement of craniofacial anthropometry
craniofacial width
measurement of craniofacial anthropometry
craniofacial width
measurement of craniofacial anthropometry
craniofacial width
measurement of craniofacial anthropometry
craniofacial width
measurement of craniofacial anthropometry
craniofacial width
measurement of craniofacial anthropometry
craniofacial volume
measurement of craniofacial anthropometry
craniofacial volume
measurement of craniofacial anthropometry
craniofacial volume
measurement of craniofacial anthropometry
craniofacial volume
measurement of craniofacial anthropometry
craniofacial volume
measurement of craniofacial anthropometry
craniofacial volume
measurement of craniofacial anthropometry
body weight
measurement of craniofacial anthropometry
body weight
measurement of craniofacial anthropometry
body weight
measurement of craniofacial anthropometry
body weight
measurement of craniofacial anthropometry
body weight
measurement of craniofacial anthropometry
body weight
measurement of craniofacial anthropometry
body height
measurement of craniofacial anthropometry
body height
measurement of craniofacial anthropometry
body height
measurement of craniofacial anthropometry
body height
measurement of craniofacial anthropometry
body height
measurement of craniofacial anthropometry
body height
measurement of craniofacial anthropometry
body mass index (BMI)
measurement of craniofacial anthropometry
body mass index (BMI)
measurement of craniofacial anthropometry
body mass index (BMI)
measurement of craniofacial anthropometry
body mass index (BMI)
measurement of craniofacial anthropometry
body mass index (BMI)
measurement of craniofacial anthropometry
body mass index (BMI)
measurement of craniofacial anthropometry
head circumference
measurement of craniofacial anthropometry
head circumference
measurement of craniofacial anthropometry
head circumference
measurement of craniofacial anthropometry
head circumference
measurement of craniofacial anthropometry
head circumference
measurement of craniofacial anthropometry
head circumference
measurement of craniofacial anthropometry
Secondary Outcome Measures
Full Information
NCT ID
NCT05004597
First Posted
July 28, 2021
Last Updated
August 6, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05004597
Brief Title
3D Craniofacial Morphologic Development of Healthy Infants
Official Title
Three-dimensional Normative Craniofacial Morphologic Development of Healthy Infants During the First Year of Life
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
October 27, 2020 (Actual)
Study Completion Date
November 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Development, Infant, IMAGE, Craniofacial Asymmetry, Plagiocephaly
Keywords
craniofacial development, growth chart
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all subjects longitudinally received 3D image
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
infants longitudinally received three dimensional photo
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
craniofacial height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 1 month-old
Title
craniofacial height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 2 month-old
Title
craniofacial height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 4 month-old
Title
craniofacial height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 6 month-old
Title
craniofacial height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 9 month-old
Title
craniofacial height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 12 month-old
Title
craniofacial depth
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 1 month-old
Title
craniofacial depth
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 2 month-old
Title
craniofacial depth
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 4 month-old
Title
craniofacial depth
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 6 month-old
Title
craniofacial depth
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 9 month-old
Title
craniofacial depth
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 12 month-old
Title
craniofacial width
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 1 month-old
Title
craniofacial width
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 2 month-old
Title
craniofacial width
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 4 month-old
Title
craniofacial width
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 6 month-old
Title
craniofacial width
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 9 month-old
Title
craniofacial width
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 12 month-old
Title
craniofacial volume
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 1 month-old
Title
craniofacial volume
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 2 month-old
Title
craniofacial volume
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 4 month-old
Title
craniofacial volume
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 6 month-old
Title
craniofacial volume
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 9 month-old
Title
craniofacial volume
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 12 month-old
Title
body weight
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 1 month-old
Title
body weight
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 2 month-old
Title
body weight
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 4 month-old
Title
body weight
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 6 month-old
Title
body weight
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 9 month-old
Title
body weight
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 12 month-old
Title
body height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 1 month-old
Title
body height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 2 month-old
Title
body height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 4 month-old
Title
body height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 6 month-old
Title
body height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 9 month-old
Title
body height
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 12 month-old
Title
body mass index (BMI)
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 1 month-old
Title
body mass index (BMI)
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 2 month-old
Title
body mass index (BMI)
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 4 month-old
Title
body mass index (BMI)
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 6 month-old
Title
body mass index (BMI)
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 9 month-old
Title
body mass index (BMI)
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 12 month-old
Title
head circumference
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 1 month-old
Title
head circumference
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 2 month-old
Title
head circumference
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 4 month-old
Title
head circumference
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 6 month-old
Title
head circumference
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 9 month-old
Title
head circumference
Description
measurement of craniofacial anthropometry
Time Frame
at infants' age of 12 month-old
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
15 males, and 15 females
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Asian ethnicity
healthy infants
full-term
Exclusion Criteria:
growth curve <3%
premature
congenital craniofacial anomaly
hormonal anomaly.
chromsomal anomaly
thyroid anomaly
bone anomaly
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pangyun Chou, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
three dimensional photo acquisition for newborns
Learn more about this trial
3D Craniofacial Morphologic Development of Healthy Infants
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