3D Craniofacial Morphologic Development of Healthy Infants

Not Applicable

Completed

• Conditions: IMAGE; Development, Infant; Plagiocephaly; Craniofacial Asymmetry
• Interventions: Other: three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)

• Registration Number: NCT05004597
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2018-12-04
• Primary Completion: 2020-10-27
• Study Completion: 2020-11-04
• Study First Submitted: 2021-07-28
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-06
• Last Update Submitted: 2021-08-06
• Study First Posted: 2021-08-13
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
infants longitudinally received three dimensional photo	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

Primary Outcome Measures

Name	Time	Method
body weight	at infants' age of 12 month-old	measurement of craniofacial anthropometry
craniofacial width	at infants' age of 12 month-old	measurement of craniofacial anthropometry
craniofacial volume	at infants' age of 12 month-old	measurement of craniofacial anthropometry
craniofacial height	at infants' age of 12 month-old	measurement of craniofacial anthropometry
craniofacial depth	at infants' age of 12 month-old	measurement of craniofacial anthropometry
body height	at infants' age of 12 month-old	measurement of craniofacial anthropometry
body mass index (BMI)	at infants' age of 12 month-old	measurement of craniofacial anthropometry
head circumference	at infants' age of 12 month-old	measurement of craniofacial anthropometry

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan