3D Craniofacial Morphologic Development of Healthy Infants

NCT ID: NCT05004597

Last Updated: 2021-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2020-11-04

Brief Summary

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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

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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

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Development, Infant IMAGE Craniofacial Asymmetry Plagiocephaly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

all subjects longitudinally received 3D image
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pangyunchou

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pangyun Chou, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201701939B0

Identifier Type: -

Identifier Source: org_study_id

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