3D Craniofacial Morphologic Development of Healthy Infants

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Chang Gung memorial hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: infants longitudinally received three dimensional photo; 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: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Pangyun Chou, MD, Chang Gung memorial hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 4, 2018
• Primary Completion (ACTUAL): October 27, 2020
• Study Completion (ACTUAL): November 4, 2020

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (ACTUAL): August 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: craniofacial development; growth chart
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Plagiocephaly
• Other Study ID Numbers: 201701939B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: three dimensional photo acquisition for newborns

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No