NCT05004597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

July 28, 2021

Last Update Submit

August 6, 2021

Conditions

Development, InfantIMAGECraniofacial AsymmetryPlagiocephaly

Keywords

craniofacial developmentgrowth chart

Outcome Measures

Primary Outcomes (48)

  • craniofacial height

    measurement of craniofacial anthropometry

    at infants' age of 1 month-old

  • craniofacial height

    measurement of craniofacial anthropometry

    at infants' age of 2 month-old

  • craniofacial height

    measurement of craniofacial anthropometry

    at infants' age of 4 month-old

  • craniofacial height

    measurement of craniofacial anthropometry

    at infants' age of 6 month-old

  • craniofacial height

    measurement of craniofacial anthropometry

    at infants' age of 9 month-old

  • craniofacial height

    measurement of craniofacial anthropometry

    at infants' age of 12 month-old

  • craniofacial depth

    measurement of craniofacial anthropometry

    at infants' age of 1 month-old

  • craniofacial depth

    measurement of craniofacial anthropometry

    at infants' age of 2 month-old

  • craniofacial depth

    measurement of craniofacial anthropometry

    at infants' age of 4 month-old

  • craniofacial depth

    measurement of craniofacial anthropometry

    at infants' age of 6 month-old

  • craniofacial depth

    measurement of craniofacial anthropometry

    at infants' age of 9 month-old

  • craniofacial depth

    measurement of craniofacial anthropometry

    at infants' age of 12 month-old

  • craniofacial width

    measurement of craniofacial anthropometry

    at infants' age of 1 month-old

  • craniofacial width

    measurement of craniofacial anthropometry

    at infants' age of 2 month-old

  • craniofacial width

    measurement of craniofacial anthropometry

    at infants' age of 4 month-old

  • craniofacial width

    measurement of craniofacial anthropometry

    at infants' age of 6 month-old

  • craniofacial width

    measurement of craniofacial anthropometry

    at infants' age of 9 month-old

  • craniofacial width

    measurement of craniofacial anthropometry

    at infants' age of 12 month-old

  • craniofacial volume

    measurement of craniofacial anthropometry

    at infants' age of 1 month-old

  • craniofacial volume

    measurement of craniofacial anthropometry

    at infants' age of 2 month-old

  • craniofacial volume

    measurement of craniofacial anthropometry

    at infants' age of 4 month-old

  • craniofacial volume

    measurement of craniofacial anthropometry

    at infants' age of 6 month-old

  • craniofacial volume

    measurement of craniofacial anthropometry

    at infants' age of 9 month-old

  • craniofacial volume

    measurement of craniofacial anthropometry

    at infants' age of 12 month-old

  • body weight

    measurement of craniofacial anthropometry

    at infants' age of 1 month-old

  • body weight

    measurement of craniofacial anthropometry

    at infants' age of 2 month-old

  • body weight

    measurement of craniofacial anthropometry

    at infants' age of 4 month-old

  • body weight

    measurement of craniofacial anthropometry

    at infants' age of 6 month-old

  • body weight

    measurement of craniofacial anthropometry

    at infants' age of 9 month-old

  • body weight

    measurement of craniofacial anthropometry

    at infants' age of 12 month-old

  • body height

    measurement of craniofacial anthropometry

    at infants' age of 1 month-old

  • body height

    measurement of craniofacial anthropometry

    at infants' age of 2 month-old

  • body height

    measurement of craniofacial anthropometry

    at infants' age of 4 month-old

  • body height

    measurement of craniofacial anthropometry

    at infants' age of 6 month-old

  • body height

    measurement of craniofacial anthropometry

    at infants' age of 9 month-old

  • body height

    measurement of craniofacial anthropometry

    at infants' age of 12 month-old

  • body mass index (BMI)

    measurement of craniofacial anthropometry

    at infants' age of 1 month-old

  • body mass index (BMI)

    measurement of craniofacial anthropometry

    at infants' age of 2 month-old

  • body mass index (BMI)

    measurement of craniofacial anthropometry

    at infants' age of 4 month-old

  • body mass index (BMI)

    measurement of craniofacial anthropometry

    at infants' age of 6 month-old

  • body mass index (BMI)

    measurement of craniofacial anthropometry

    at infants' age of 9 month-old

  • body mass index (BMI)

    measurement of craniofacial anthropometry

    at infants' age of 12 month-old

  • head circumference

    measurement of craniofacial anthropometry

    at infants' age of 1 month-old

  • head circumference

    measurement of craniofacial anthropometry

    at infants' age of 2 month-old

  • head circumference

    measurement of craniofacial anthropometry

    at infants' age of 4 month-old

  • head circumference

    measurement of craniofacial anthropometry

    at infants' age of 6 month-old

  • head circumference

    measurement of craniofacial anthropometry

    at infants' age of 9 month-old

  • head circumference

    measurement of craniofacial anthropometry

    at infants' age of 12 month-old

Study Arms (1)

infants longitudinally received three dimensional photo

EXPERIMENTAL

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

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.

infants longitudinally received three dimensional photo

Eligibility Criteria

Age1 Month - 12 Months
Sexall(Gender-based eligibility)
Gender Eligibility Details15 males, and 15 females
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Asian ethnicity
  • healthy infants
  • full-term

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Plagiocephaly

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Pangyun Chou, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: all subjects longitudinally received 3D image
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 13, 2021

Study Start

December 4, 2018

Primary Completion

October 27, 2020

Study Completion

November 4, 2020

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

three dimensional photo acquisition for newborns

Locations

TW(1)