Clinical Trials Directory

Trials / Completed

CompletedNCT05004597

3D Craniofacial Morphologic Development of Healthy Infants

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Chang Gung Memorial Hospital · Academic / Other
Sex
All
Age
1 Month – 12 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERthree 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.

Timeline

Start date
2018-12-04
Primary completion
2020-10-27
Completion
2020-11-04
First posted
2021-08-13
Last updated
2021-08-13

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT05004597. Inclusion in this directory is not an endorsement.