Clinical trial NCT05004597: 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
Overall status: COMPLETED
Phase: NA
Conditions: Development, Infant
IMAGE
Craniofacial Asymmetry
Plagiocephaly
Keywords: craniofacial development
growth chart
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all subjects longitudinally received 3D image
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: craniofacial height
timeFrame: at infants' age of 1 month-old
measure: craniofacial height
timeFrame: at infants' age of 2 month-old
measure: craniofacial height
timeFrame: at infants' age of 4 month-old
measure: craniofacial height
timeFrame: at infants' age of 6 month-old
measure: craniofacial height
timeFrame: at infants' age of 9 month-old
measure: craniofacial height
timeFrame: at infants' age of 12 month-old
measure: craniofacial depth
timeFrame: at infants' age of 1 month-old
measure: craniofacial depth
timeFrame: at infants' age of 2 month-old
measure: craniofacial depth
timeFrame: at infants' age of 4 month-old
measure: craniofacial depth
timeFrame: at infants' age of 6 month-old
measure: craniofacial depth
timeFrame: at infants' age of 9 month-old
measure: craniofacial depth
timeFrame: at infants' age of 12 month-old
measure: craniofacial width
timeFrame: at infants' age of 1 month-old
measure: craniofacial width
timeFrame: at infants' age of 2 month-old
measure: craniofacial width
timeFrame: at infants' age of 4 month-old
measure: craniofacial width
timeFrame: at infants' age of 6 month-old
measure: craniofacial width
timeFrame: at infants' age of 9 month-old
measure: craniofacial width
timeFrame: at infants' age of 12 month-old
measure: craniofacial volume
timeFrame: at infants' age of 1 month-old
measure: craniofacial volume
timeFrame: at infants' age of 2 month-old
measure: craniofacial volume
timeFrame: at infants' age of 4 month-old
measure: craniofacial volume
timeFrame: at infants' age of 6 month-old
measure: craniofacial volume
timeFrame: at infants' age of 9 month-old
measure: craniofacial volume
timeFrame: at infants' age of 12 month-old
measure: body weight
timeFrame: at infants' age of 1 month-old
measure: body weight
timeFrame: at infants' age of 2 month-old
measure: body weight
timeFrame: at infants' age of 4 month-old
measure: body weight
timeFrame: at infants' age of 6 month-old
measure: body weight
timeFrame: at infants' age of 9 month-old
measure: body weight
timeFrame: at infants' age of 12 month-old
measure: body height
timeFrame: at infants' age of 1 month-old
measure: body height
timeFrame: at infants' age of 2 month-old
measure: body height
timeFrame: at infants' age of 4 month-old
measure: body height
timeFrame: at infants' age of 6 month-old
measure: body height
timeFrame: at infants' age of 9 month-old
measure: body height
timeFrame: at infants' age of 12 month-old
measure: body mass index (BMI)
timeFrame: at infants' age of 1 month-old
measure: body mass index (BMI)
timeFrame: at infants' age of 2 month-old
measure: body mass index (BMI)
timeFrame: at infants' age of 4 month-old
measure: body mass index (BMI)
timeFrame: at infants' age of 6 month-old
measure: body mass index (BMI)
timeFrame: at infants' age of 9 month-old
measure: body mass index (BMI)
timeFrame: at infants' age of 12 month-old
measure: head circumference
timeFrame: at infants' age of 1 month-old
measure: head circumference
timeFrame: at infants' age of 2 month-old
measure: head circumference
timeFrame: at infants' age of 4 month-old
measure: head circumference
timeFrame: at infants' age of 6 month-old
measure: head circumference
timeFrame: at infants' age of 9 month-old
measure: head circumference
timeFrame: at infants' age of 12 month-old
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Pangyun Chou, MD
role: PRINCIPAL_INVESTIGATOR
References: