Please note that IPD sharing statement and summary results sections will be added to the ANZCTR form in the coming weeks in order to comply with the updated WHO Trial Registration Data Set.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 478 0
Country [1] 478 0
United States of America
Funding source category [2] 479 0
Commercial sector/Industry
Name [2] 479 0
Interclinical Laboratories
Address [2] 479 0
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