3D Craniofacial Morphologic Development of Healthy Infants

Development, Infant Clinical Trial

Official title:

Three-dimensional Normative Craniofacial Morphologic Development of Healthy Infants During the First Year of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004597
• Other study ID #: 201701939B0
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: November 4, 2020

Study information

• Verified date: August 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 4, 2020
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Development, Infant
• IMAGE
• Plagiocephaly

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	craniofacial height	measurement of craniofacial anthropometry	at infants' age of 1 month-old
Primary	craniofacial height	measurement of craniofacial anthropometry	at infants' age of 2 month-old
Primary	craniofacial height	measurement of craniofacial anthropometry	at infants' age of 4 month-old
Primary	craniofacial height	measurement of craniofacial anthropometry	at infants' age of 6 month-old
Primary	craniofacial height	measurement of craniofacial anthropometry	at infants' age of 9 month-old
Primary	craniofacial height	measurement of craniofacial anthropometry	at infants' age of 12 month-old
Primary	craniofacial depth	measurement of craniofacial anthropometry	at infants' age of 1 month-old
Primary	craniofacial depth	measurement of craniofacial anthropometry	at infants' age of 2 month-old
Primary	craniofacial depth	measurement of craniofacial anthropometry	at infants' age of 4 month-old
Primary	craniofacial depth	measurement of craniofacial anthropometry	at infants' age of 6 month-old
Primary	craniofacial depth	measurement of craniofacial anthropometry	at infants' age of 9 month-old
Primary	craniofacial depth	measurement of craniofacial anthropometry	at infants' age of 12 month-old
Primary	craniofacial width	measurement of craniofacial anthropometry	at infants' age of 1 month-old
Primary	craniofacial width	measurement of craniofacial anthropometry	at infants' age of 2 month-old
Primary	craniofacial width	measurement of craniofacial anthropometry	at infants' age of 4 month-old
Primary	craniofacial width	measurement of craniofacial anthropometry	at infants' age of 6 month-old
Primary	craniofacial width	measurement of craniofacial anthropometry	at infants' age of 9 month-old
Primary	craniofacial width	measurement of craniofacial anthropometry	at infants' age of 12 month-old
Primary	craniofacial volume	measurement of craniofacial anthropometry	at infants' age of 1 month-old
Primary	craniofacial volume	measurement of craniofacial anthropometry	at infants' age of 2 month-old
Primary	craniofacial volume	measurement of craniofacial anthropometry	at infants' age of 4 month-old
Primary	craniofacial volume	measurement of craniofacial anthropometry	at infants' age of 6 month-old
Primary	craniofacial volume	measurement of craniofacial anthropometry	at infants' age of 9 month-old
Primary	craniofacial volume	measurement of craniofacial anthropometry	at infants' age of 12 month-old
Primary	body weight	measurement of craniofacial anthropometry	at infants' age of 1 month-old
Primary	body weight	measurement of craniofacial anthropometry	at infants' age of 2 month-old
Primary	body weight	measurement of craniofacial anthropometry	at infants' age of 4 month-old
Primary	body weight	measurement of craniofacial anthropometry	at infants' age of 6 month-old
Primary	body weight	measurement of craniofacial anthropometry	at infants' age of 9 month-old
Primary	body weight	measurement of craniofacial anthropometry	at infants' age of 12 month-old
Primary	body height	measurement of craniofacial anthropometry	at infants' age of 1 month-old
Primary	body height	measurement of craniofacial anthropometry	at infants' age of 2 month-old
Primary	body height	measurement of craniofacial anthropometry	at infants' age of 4 month-old
Primary	body height	measurement of craniofacial anthropometry	at infants' age of 6 month-old
Primary	body height	measurement of craniofacial anthropometry	at infants' age of 9 month-old
Primary	body height	measurement of craniofacial anthropometry	at infants' age of 12 month-old
Primary	body mass index (BMI)	measurement of craniofacial anthropometry	at infants' age of 1 month-old
Primary	body mass index (BMI)	measurement of craniofacial anthropometry	at infants' age of 2 month-old
Primary	body mass index (BMI)	measurement of craniofacial anthropometry	at infants' age of 4 month-old
Primary	body mass index (BMI)	measurement of craniofacial anthropometry	at infants' age of 6 month-old
Primary	body mass index (BMI)	measurement of craniofacial anthropometry	at infants' age of 9 month-old
Primary	body mass index (BMI)	measurement of craniofacial anthropometry	at infants' age of 12 month-old
Primary	head circumference	measurement of craniofacial anthropometry	at infants' age of 1 month-old
Primary	head circumference	measurement of craniofacial anthropometry	at infants' age of 2 month-old
Primary	head circumference	measurement of craniofacial anthropometry	at infants' age of 4 month-old
Primary	head circumference	measurement of craniofacial anthropometry	at infants' age of 6 month-old
Primary	head circumference	measurement of craniofacial anthropometry	at infants' age of 9 month-old
Primary	head circumference	measurement of craniofacial anthropometry	at infants' age of 12 month-old