Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000276651
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
2/09/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Craniofacial Deformities in Children -
Trial to Understand the Aetiology of Non-syndromic Cleft Lip and Palate
Scientific title
Craniofacial Deformities in Children -
Trial to Understand the Aetiology of Non-syndromic Cleft Lip and Palate
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cleft lip and palate 364 0
Condition category
Condition code
Reproductive Health and Childbirth 426 426 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention at this stage but measurement of metabolic markers in blood and hair.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 487 0
To find connections between cleft lip and palate with genetics.
Timepoint [1] 487 0
Primary outcome [2] 488 0
To find connections between cleft lip and palate with nutritional status.
Timepoint [2] 488 0
Primary outcome [3] 489 0
To find connections between cleft lip and palate with toxin exposure.
Timepoint [3] 489 0
Secondary outcome [1] 1051 0
None at this stage
Timepoint [1] 1051 0

Eligibility
Key inclusion criteria
Children under the age of two years with non-syndromic cleft lip and/or palate.
Minimum age
0 Years
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 478 0
Commercial sector/Industry
Name [1] 478 0
Metametrix Laboratories
Country [1] 478 0
United States of America
Funding source category [2] 479 0
Commercial sector/Industry
Name [2] 479 0
Interclinical Laboratories
Country [2] 479 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Metametrix Laboratories
Address
Country
United States of America
Secondary sponsor category [1] 386 0
Commercial sector/Industry
Name [1] 386 0
Interclinical Laboratories
Address [1] 386 0
Country [1] 386 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1456 0
Southern Cross University
Ethics committee address [1] 1456 0
Ethics committee country [1] 1456 0
Australia
Date submitted for ethics approval [1] 1456 0
Approval date [1] 1456 0
Ethics approval number [1] 1456 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35114 0
Address 35114 0
Country 35114 0
Phone 35114 0
Fax 35114 0
Email 35114 0
Contact person for public queries
Name 9483 0
Dr. Tini Gruner
Address 9483 0
SN&CM
Southern Cross University
PO Box 157
Lismore NSW 2480
Country 9483 0
Australia
Phone 9483 0
+61 2 66203349
Fax 9483 0
Email 9483 0
tgruner@scu.edu.au
Contact person for scientific queries
Name 411 0
Graeme Wallace
Address 411 0
1/13 Elizabeth St
Doncaster East VIC 3109
Country 411 0
Australia
Phone 411 0
+61 3 98483514 or +61 3 98487890
Fax 411 0
Email 411 0
graemew@bigpond.net.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.