NCT01274299

Brief Summary

Anthropometric data of infants' face will be obtained using special 3D scanners and software.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

First QC Date

December 28, 2010

Last Update Submit

January 9, 2011

Conditions

Infant Development

Keywords

Infantsmorphometryface3D

Outcome Measures

Primary Outcomes (1)

  • Facial Dimensions

    Landmarks that are relevant to face mask application such as the distance from the chin to the bridge of the nose will be marked and measured.

    5 minutes

Study Arms (1)

Infants

Healthy 0-4 years of age both boys and girls

Procedure: Digital camera picture

Interventions

Digital camera picturePROCEDURE

A digital camera will be used to take a 3D picture the face of each infant. Off line measurements of landmarks on the face will be marked and dimensions will be calculated using a special analysis software.

Also known as: none applicable
Infants

Eligibility Criteria

AgeUp to 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Healthy infants

You may qualify if:

  • Healthy infants, 0-4 years of age

You may not qualify if:

  • Facial anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Medical center

Safed, 13100, Israel

RECRUITING

Related Publications (2)

  • Amirav I, Luder AS, Halamish A, Marzuk C, Daitzchman M, Newhouse MT. Computerized Dead-Space Volume Measurement of Face Masks Applied to Simulated Faces. Respir Care. 2015 Sep;60(9):1247-51. doi: 10.4187/respcare.03813. Epub 2015 May 5.

    PMID: 25944944DERIVED

  • Amirav I, Luder AS, Halamish A, Raviv D, Kimmel R, Waisman D, Newhouse MT. Design of aerosol face masks for children using computerized 3D face analysis. J Aerosol Med Pulm Drug Deliv. 2014 Aug;27(4):272-8. doi: 10.1089/jamp.2013.1069. Epub 2013 Sep 28.

    PMID: 24074142DERIVED

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Israel Amirav, MD

    Ziv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Israel Amirav, MD

CONTACT

97246828712amirav@012.net.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 28, 2010

First Posted

January 11, 2011

Study Start

November 1, 2010

Study Completion

November 1, 2012

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

IL(1)