3D Craniofacial Morphologic Development of Healthy Infants

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05004597
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 23
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Development, Infant; IMAGE; Craniofacial Asymmetry; Plagiocephaly	Other: three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: all subjects longitudinally received 3D imageall subjects longitudinally received 3D image
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Three-dimensional Normative Craniofacial Morphologic Development of Healthy Infants During the First Year of Life
• Actual Study Start Date: Dec 4, 2018
• Actual Primary Completion Date: Oct 27, 2020
• Actual Study Completion Date: Nov 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
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); 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.

Outcome Measures

Primary Outcome Measures

1. craniofacial height [at infants' age of 1 month-old]

   measurement of craniofacial anthropometry

2. craniofacial height [at infants' age of 2 month-old]

   measurement of craniofacial anthropometry

3. craniofacial height [at infants' age of 4 month-old]

   measurement of craniofacial anthropometry

4. craniofacial height [at infants' age of 6 month-old]

   measurement of craniofacial anthropometry

5. craniofacial height [at infants' age of 9 month-old]

   measurement of craniofacial anthropometry

6. craniofacial height [at infants' age of 12 month-old]

   measurement of craniofacial anthropometry

7. craniofacial depth [at infants' age of 1 month-old]

   measurement of craniofacial anthropometry

8. craniofacial depth [at infants' age of 2 month-old]

   measurement of craniofacial anthropometry

9. craniofacial depth [at infants' age of 4 month-old]

   measurement of craniofacial anthropometry

10. craniofacial depth [at infants' age of 6 month-old]

    measurement of craniofacial anthropometry

11. craniofacial depth [at infants' age of 9 month-old]

    measurement of craniofacial anthropometry

12. craniofacial depth [at infants' age of 12 month-old]

    measurement of craniofacial anthropometry

13. craniofacial width [at infants' age of 1 month-old]

    measurement of craniofacial anthropometry

14. craniofacial width [at infants' age of 2 month-old]

    measurement of craniofacial anthropometry

15. craniofacial width [at infants' age of 4 month-old]

    measurement of craniofacial anthropometry

16. craniofacial width [at infants' age of 6 month-old]

    measurement of craniofacial anthropometry

17. craniofacial width [at infants' age of 9 month-old]

    measurement of craniofacial anthropometry

18. craniofacial width [at infants' age of 12 month-old]

    measurement of craniofacial anthropometry

19. craniofacial volume [at infants' age of 1 month-old]

    measurement of craniofacial anthropometry

20. craniofacial volume [at infants' age of 2 month-old]

    measurement of craniofacial anthropometry

21. craniofacial volume [at infants' age of 4 month-old]

    measurement of craniofacial anthropometry

22. craniofacial volume [at infants' age of 6 month-old]

    measurement of craniofacial anthropometry

23. craniofacial volume [at infants' age of 9 month-old]

    measurement of craniofacial anthropometry

24. craniofacial volume [at infants' age of 12 month-old]

    measurement of craniofacial anthropometry

25. body weight [at infants' age of 1 month-old]

    measurement of craniofacial anthropometry

26. body weight [at infants' age of 2 month-old]

    measurement of craniofacial anthropometry

27. body weight [at infants' age of 4 month-old]

    measurement of craniofacial anthropometry

28. body weight [at infants' age of 6 month-old]

    measurement of craniofacial anthropometry

29. body weight [at infants' age of 9 month-old]

    measurement of craniofacial anthropometry

30. body weight [at infants' age of 12 month-old]

    measurement of craniofacial anthropometry

31. body height [at infants' age of 1 month-old]

    measurement of craniofacial anthropometry

32. body height [at infants' age of 2 month-old]

    measurement of craniofacial anthropometry

33. body height [at infants' age of 4 month-old]

    measurement of craniofacial anthropometry

34. body height [at infants' age of 6 month-old]

    measurement of craniofacial anthropometry

35. body height [at infants' age of 9 month-old]

    measurement of craniofacial anthropometry

36. body height [at infants' age of 12 month-old]

    measurement of craniofacial anthropometry

37. body mass index (BMI) [at infants' age of 1 month-old]

    measurement of craniofacial anthropometry

38. body mass index (BMI) [at infants' age of 2 month-old]

    measurement of craniofacial anthropometry

39. body mass index (BMI) [at infants' age of 4 month-old]

    measurement of craniofacial anthropometry

40. body mass index (BMI) [at infants' age of 6 month-old]

    measurement of craniofacial anthropometry

41. body mass index (BMI) [at infants' age of 9 month-old]

    measurement of craniofacial anthropometry

42. body mass index (BMI) [at infants' age of 12 month-old]

    measurement of craniofacial anthropometry

43. head circumference [at infants' age of 1 month-old]

    measurement of craniofacial anthropometry

44. head circumference [at infants' age of 2 month-old]

    measurement of craniofacial anthropometry

45. head circumference [at infants' age of 4 month-old]

    measurement of craniofacial anthropometry

46. head circumference [at infants' age of 6 month-old]

    measurement of craniofacial anthropometry

47. head circumference [at infants' age of 9 month-old]

    measurement of craniofacial anthropometry

48. head circumference [at infants' age of 12 month-old]

    measurement of craniofacial anthropometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 12 Months
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Taoyuan		Taiwan

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

• Principal Investigator: Pangyun Chou, MD, Chang Gung Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pangyunchou, Assistant professor, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05004597
• Other Study ID Numbers: 201701939B0
• First Posted: Aug 13, 2021
• Last Update Posted: Aug 13, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pangyunchou, Assistant professor, Chang Gung Memorial Hospital: craniofacial development; growth chart
• Additional relevant MeSH terms: Plagiocephaly

Study Results

No Results Posted as of Aug 13, 2021