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Completed

NCT Number: NCT05004597

3D Craniofacial Morphologic Development of Healthy Infants

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.

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Key information

Conditions

Development, Infant Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniofacial Asymmetry Image Musculoskeletal Abnormalities Musculoskeletal Diseases Plagiocephaly

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. craniofacial height

    Time frame: at infants' age of 1 month-old

    measurement of craniofacial anthropometry

  2. craniofacial height

    Time frame: at infants' age of 2 month-old

    measurement of craniofacial anthropometry

  3. craniofacial height

    Time frame: at infants' age of 4 month-old

    measurement of craniofacial anthropometry

  4. craniofacial height

    Time frame: at infants' age of 6 month-old

    measurement of craniofacial anthropometry

  5. craniofacial height

    Time frame: at infants' age of 9 month-old

    measurement of craniofacial anthropometry

  6. craniofacial height

    Time frame: at infants' age of 12 month-old

    measurement of craniofacial anthropometry

  7. craniofacial depth

    Time frame: at infants' age of 1 month-old

    measurement of craniofacial anthropometry

  8. craniofacial depth

    Time frame: at infants' age of 2 month-old

    measurement of craniofacial anthropometry

  9. craniofacial depth

    Time frame: at infants' age of 4 month-old

    measurement of craniofacial anthropometry

  10. craniofacial depth

    Time frame: at infants' age of 6 month-old

    measurement of craniofacial anthropometry

  11. craniofacial depth

    Time frame: at infants' age of 9 month-old

    measurement of craniofacial anthropometry

  12. craniofacial depth

    Time frame: at infants' age of 12 month-old

    measurement of craniofacial anthropometry

  13. craniofacial width

    Time frame: at infants' age of 1 month-old

    measurement of craniofacial anthropometry

  14. craniofacial width

    Time frame: at infants' age of 2 month-old

    measurement of craniofacial anthropometry

  15. craniofacial width

    Time frame: at infants' age of 4 month-old

    measurement of craniofacial anthropometry

  16. craniofacial width

    Time frame: at infants' age of 6 month-old

    measurement of craniofacial anthropometry

  17. craniofacial width

    Time frame: at infants' age of 9 month-old

    measurement of craniofacial anthropometry

  18. craniofacial width

    Time frame: at infants' age of 12 month-old

    measurement of craniofacial anthropometry

  19. craniofacial volume

    Time frame: at infants' age of 1 month-old

    measurement of craniofacial anthropometry

  20. craniofacial volume

    Time frame: at infants' age of 2 month-old

    measurement of craniofacial anthropometry

  21. craniofacial volume

    Time frame: at infants' age of 4 month-old

    measurement of craniofacial anthropometry

  22. craniofacial volume

    Time frame: at infants' age of 6 month-old

    measurement of craniofacial anthropometry

  23. craniofacial volume

    Time frame: at infants' age of 9 month-old

    measurement of craniofacial anthropometry

  24. craniofacial volume

    Time frame: at infants' age of 12 month-old

    measurement of craniofacial anthropometry

  25. body weight

    Time frame: at infants' age of 1 month-old

    measurement of craniofacial anthropometry

  26. body weight

    Time frame: at infants' age of 2 month-old

    measurement of craniofacial anthropometry

  27. body weight

    Time frame: at infants' age of 4 month-old

    measurement of craniofacial anthropometry

  28. body weight

    Time frame: at infants' age of 6 month-old

    measurement of craniofacial anthropometry

  29. body weight

    Time frame: at infants' age of 9 month-old

    measurement of craniofacial anthropometry

  30. body weight

    Time frame: at infants' age of 12 month-old

    measurement of craniofacial anthropometry

  31. body height

    Time frame: at infants' age of 1 month-old

    measurement of craniofacial anthropometry

  32. body height

    Time frame: at infants' age of 2 month-old

    measurement of craniofacial anthropometry

  33. body height

    Time frame: at infants' age of 4 month-old

    measurement of craniofacial anthropometry

  34. body height

    Time frame: at infants' age of 6 month-old

    measurement of craniofacial anthropometry

  35. body height

    Time frame: at infants' age of 9 month-old

    measurement of craniofacial anthropometry

  36. body height

    Time frame: at infants' age of 12 month-old

    measurement of craniofacial anthropometry

  37. body mass index (BMI)

    Time frame: at infants' age of 1 month-old

    measurement of craniofacial anthropometry

  38. body mass index (BMI)

    Time frame: at infants' age of 2 month-old

    measurement of craniofacial anthropometry

  39. body mass index (BMI)

    Time frame: at infants' age of 4 month-old

    measurement of craniofacial anthropometry

  40. body mass index (BMI)

    Time frame: at infants' age of 6 month-old

    measurement of craniofacial anthropometry

  41. body mass index (BMI)

    Time frame: at infants' age of 9 month-old

    measurement of craniofacial anthropometry

  42. body mass index (BMI)

    Time frame: at infants' age of 12 month-old

    measurement of craniofacial anthropometry

  43. head circumference

    Time frame: at infants' age of 1 month-old

    measurement of craniofacial anthropometry

  44. head circumference

    Time frame: at infants' age of 2 month-old

    measurement of craniofacial anthropometry

  45. head circumference

    Time frame: at infants' age of 4 month-old

    measurement of craniofacial anthropometry

  46. head circumference

    Time frame: at infants' age of 6 month-old

    measurement of craniofacial anthropometry

  47. head circumference

    Time frame: at infants' age of 9 month-old

    measurement of craniofacial anthropometry

  48. head circumference

    Time frame: at infants' age of 12 month-old

    measurement of craniofacial anthropometry

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2021
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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