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3D Craniofacial Morphologic Development of Healthy Infants

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05004597
Enrollment
30
Registered
2021-08-13
Start date
2018-12-04
Completion date
2020-11-04
Last updated
2021-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniofacial Asymmetry, Development, Infant, IMAGE, Plagiocephaly

Keywords

craniofacial development, growth chart

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.

Interventions

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

all subjects longitudinally received 3D image

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
craniofacial heightat infants' age of 1 month-oldmeasurement of craniofacial anthropometry
craniofacial depthat infants' age of 1 month-oldmeasurement of craniofacial anthropometry
craniofacial widthat infants' age of 1 month-oldmeasurement of craniofacial anthropometry
craniofacial volumeat infants' age of 1 month-oldmeasurement of craniofacial anthropometry
body weightat infants' age of 1 month-oldmeasurement of craniofacial anthropometry
body heightat infants' age of 1 month-oldmeasurement of craniofacial anthropometry
body mass index (BMI)at infants' age of 1 month-oldmeasurement of craniofacial anthropometry
head circumferenceat infants' age of 1 month-oldmeasurement of craniofacial anthropometry

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026