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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05004597
Other study ID # 201701939B0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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