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临床试验/NCT05004597
NCT05004597已完成不适用

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

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
body weight

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
1 Month 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Asian ethnicity
  • healthy infants
  • full-term

排除标准

  • growth curve <3%
  • premature
  • congenital craniofacial anomaly
  • hormonal anomaly.
  • chromsomal anomaly
  • thyroid anomaly
  • bone anomaly

结局指标

主要结局

body weight

时间窗: at infants' age of 12 month-old

measurement of craniofacial anthropometry

craniofacial width

时间窗: at infants' age of 12 month-old

measurement of craniofacial anthropometry

craniofacial volume

时间窗: at infants' age of 12 month-old

measurement of craniofacial anthropometry

craniofacial height

时间窗: at infants' age of 12 month-old

measurement of craniofacial anthropometry

craniofacial depth

时间窗: at infants' age of 12 month-old

measurement of craniofacial anthropometry

body height

时间窗: at infants' age of 12 month-old

measurement of craniofacial anthropometry

body mass index (BMI)

时间窗: at infants' age of 12 month-old

measurement of craniofacial anthropometry

head circumference

时间窗: at infants' age of 12 month-old

measurement of craniofacial anthropometry

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pangyunchou

Assistant professor

Chang Gung Memorial Hospital

研究点 (1)

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