NCT00705055

Brief Summary

The hypothesis to be tested: After the construction of a database of anthropometric measurements, the system would extract important features of a given facial surface and be able to match it with existing morphometric figures. A given combination of normal and abnormal measurements will open a "probable diagnosis" and a list of "differential diagnosis" that will be expressed as percent of matching in a descendent order to the examiner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

November 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2013

Completed
Last Updated

August 9, 2017

Status Verified

November 1, 2013

Enrollment Period

6.2 years

First QC Date

June 19, 2008

Last Update Submit

August 8, 2017

Conditions

Genetic Disorders

Keywords

Anthropometryface recognitiongenetic diseasenewborn infant

Outcome Measures

Primary Outcomes (1)

  • To create the bases for a "normal patterns" database

Study Arms (4)

1

Normal Males

2

Normal Females

3

Abnormal Males

4

Abnormal Females

Eligibility Criteria

Age1 Hour - 2 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborn infants born at Carmel Medical Center or at Soroka Medical Center

You may qualify if:

  • all newborn infants born at the Carmel Medical Center following parental consent, and at Soroka Medical Center.

You may not qualify if:

  • No parental consent; Facial deformation not related to chromosomal or genetic anomalies; babies transferred to the neonatal intensive care unit that need ventilatory support.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Neonatology, Soroka University Medical Center

Beersheba, Israel

Location

Department of Neonatology, Carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Dan Waisman, MD

    Department of Neonatology, Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 25, 2008

Study Start

November 1, 2007

Primary Completion

December 30, 2013

Study Completion

December 30, 2013

Last Updated

August 9, 2017

Record last verified: 2013-11

Locations

IL(2)