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CompletedNCT05004597Updated Aug 13, 2021

3D Craniofacial Morphologic Development of Healthy Infants

An interventional study of three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA) in Development, Infant, IMAGE and Craniofacial Asymmetry, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 1 Month to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-13.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Dec 2018, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
1 Month to 12 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Development, Infant
  • IMAGE
  • Craniofacial Asymmetry
  • Plagiocephaly

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Keywords

  • craniofacial development
  • growth chart
03

In context

Plagiocephaly

16 studies on the registry are indexed under Plagiocephaly; 4 are open to participants now.

Browse Plagiocephaly studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 12 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Asian ethnicity
  • healthy infants
  • full-term

Exclusion criteria

Exclusion Criteria:

  • growth curve \<3%
  • premature
  • congenital craniofacial anomaly
  • hormonal anomaly.
  • chromsomal anomaly
  • thyroid anomaly
  • bone anomaly
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    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

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

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.

06

What researchers measure

Primary outcomes

  1. craniofacial height

    measurement of craniofacial anthropometry

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

  2. craniofacial height

    measurement of craniofacial anthropometry

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

  3. craniofacial height

    measurement of craniofacial anthropometry

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

  4. craniofacial height

    measurement of craniofacial anthropometry

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

  5. craniofacial height

    measurement of craniofacial anthropometry

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

  6. craniofacial height

    measurement of craniofacial anthropometry

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

  7. craniofacial depth

    measurement of craniofacial anthropometry

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

  8. craniofacial depth

    measurement of craniofacial anthropometry

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

  9. craniofacial depth

    measurement of craniofacial anthropometry

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

  10. craniofacial depth

    measurement of craniofacial anthropometry

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

  11. craniofacial depth

    measurement of craniofacial anthropometry

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

  12. craniofacial depth

    measurement of craniofacial anthropometry

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

  13. craniofacial width

    measurement of craniofacial anthropometry

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

  14. craniofacial width

    measurement of craniofacial anthropometry

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

  15. craniofacial width

    measurement of craniofacial anthropometry

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

  16. craniofacial width

    measurement of craniofacial anthropometry

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

  17. craniofacial width

    measurement of craniofacial anthropometry

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

  18. craniofacial width

    measurement of craniofacial anthropometry

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

  19. craniofacial volume

    measurement of craniofacial anthropometry

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

  20. craniofacial volume

    measurement of craniofacial anthropometry

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

  21. craniofacial volume

    measurement of craniofacial anthropometry

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

  22. craniofacial volume

    measurement of craniofacial anthropometry

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

  23. craniofacial volume

    measurement of craniofacial anthropometry

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

  24. craniofacial volume

    measurement of craniofacial anthropometry

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

  25. body weight

    measurement of craniofacial anthropometry

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

  26. body weight

    measurement of craniofacial anthropometry

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

  27. body weight

    measurement of craniofacial anthropometry

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

  28. body weight

    measurement of craniofacial anthropometry

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

  29. body weight

    measurement of craniofacial anthropometry

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

  30. body weight

    measurement of craniofacial anthropometry

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

  31. body height

    measurement of craniofacial anthropometry

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

  32. body height

    measurement of craniofacial anthropometry

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

  33. body height

    measurement of craniofacial anthropometry

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

  34. body height

    measurement of craniofacial anthropometry

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

  35. body height

    measurement of craniofacial anthropometry

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

  36. body height

    measurement of craniofacial anthropometry

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

  37. body mass index (BMI)

    measurement of craniofacial anthropometry

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

  38. body mass index (BMI)

    measurement of craniofacial anthropometry

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

  39. body mass index (BMI)

    measurement of craniofacial anthropometry

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

  40. body mass index (BMI)

    measurement of craniofacial anthropometry

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

  41. body mass index (BMI)

    measurement of craniofacial anthropometry

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

  42. body mass index (BMI)

    measurement of craniofacial anthropometry

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

  43. head circumference

    measurement of craniofacial anthropometry

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

  44. head circumference

    measurement of craniofacial anthropometry

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

  45. head circumference

    measurement of craniofacial anthropometry

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

  46. head circumference

    measurement of craniofacial anthropometry

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

  47. head circumference

    measurement of craniofacial anthropometry

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

  48. head circumference

    measurement of craniofacial anthropometry

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

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taoyuan, Taiwan
08

References and documents

Individual participant data

Plan to share: No — three dimensional photo acquisition for newborns

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2018 to primary completion in Oct 2020, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2021
First posted
Aug 13, 2021
StartActual
Dec 4, 2018
Primary completionActual
Oct 27, 2020
CompletionActual
Nov 4, 2020
Last update
Aug 13, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05004597
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Pangyunchou (Assistant professor, Chang Gung Memorial Hospital) — Principal investigator
First posted
Aug 13, 2021
Start date
Dec 4, 2018
Primary completion
Oct 27, 2020
Completion
Nov 4, 2020
Last update
Aug 13, 2021

Study contacts

Pangyun Chou, MD
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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