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3D Craniofacial Morphologic Development of Healthy Infants

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Plagiocephaly
IMAGE
Craniofacial Asymmetry
Development, Infant

Treatments

Other: three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)

Study type

Interventional

Funder types

Other

Identifiers

NCT05004597
201701939B0

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

1 to 12 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

infants longitudinally received three dimensional photo
Experimental group
Description:
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
Treatment:
Other: three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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