Infant DevelopmentNCT01274299
Measurements of Facial Dimensions in Infants and Toddlers 0-4 Years of Age
An observational study of Infant Development, run by Ziv Hospital at 1 site in Israel.
Trial summary
Anthropometric data of infants' face will be obtained using special 3D scanners and software. Read more about this study
- Who is it for?
- Ages Up to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Digital camera picture
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2010to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy infants
Who may be able to join
- Healthy infants, 0-4 years of age
Who cannot join
- Facial anomalies
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ziv Medical center
Safed, 13100
Israel Amirav, MD, 97246828712, amirav@012.net.il
Israel Amirav, MD
About this study
Official title: Facial Dimensions in Infants and Toddlers
Anthropometric data of infants' face will be obtained using special 3D scanners and software.
Read the detailed description
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.
- Conditions
- Infant Development
- Being tested
- Digital camera picture
- Keywords
- Infants, morphometry, face, 3D
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital camera pictureProcedure or surgery
Also called none applicable
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.
| Study group | Role | What they receive |
|---|---|---|
| Infants | Healthy 0-4 years of age both boys and girls Receives: Procedure: Digital camera picture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startNov 2010
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Investigators
- Israel Amirav, MD, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274299
- Sponsor's protocol ID
- 0067-10-ZIV
- Status last verified
- Jan 2011
- First submitted
- 28 Dec 2010
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25944944Amirav 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.
PubMed 24074142
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Dimensions in Infants and Toddlers
- ClinicalTrials.gov ID
- NCT01274299
- Acronym / sponsor ID
- 0067-10-ZIV
- Conditions
- Infant Development
- Keywords
- Infants, morphometry, face, 3D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Nov 2010
- Study completion
- Nov 2012 (estimated)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anthropometric data of infants' face will be obtained using special 3D scanners and software.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants | – | Procedure: Digital camera pictureHealthy 0-4 years of age both boys and girls |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy infants
Key inclusion criteria (1 listed)
- Healthy infants, 0-4 years of age
Key exclusion criteria (1 listed)
- Facial anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital camera pictureAlso: none applicableA 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. | Procedure or surgery | Infants |
Primary outcome
Facial Dimensions
Time frame: 5 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
- Derived from this study: PubMed 25944944Amirav 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.
- Derived from this study: PubMed 24074142Amirav 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israel Amirav, MD principal investigator
Ziv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Israel Amirav, MD (97246828712, amirav@012.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Dimensions (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01274299, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.