Trial Review

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


Registration number
ACTRN12612000081819
Ethics application status
Not yet submitted
Date submitted
13/01/2012
Date registered
17/01/2012
Date last updated
17/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Health Effects in Children Exposed to Clandestine Methamphetamine Laboratories in Western Australia
Scientific title
Positive toxicology, physical assessment and developmental assessments of all children found in raided Clandestine Methamphetamine Laboratories with the aim of establishing services and clinical protocols for management of these children.
Secondary ID [1] 279725 0
NIL
Universal Trial Number (UTN)
U1111-1127-0873
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effects of exposure to clandestine methamphetamine laboratories 285565 0
Condition category
Condition code
Other 285762 285762 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Complete medical asssessment of children found in Clandestine methamphetamine laboratories. This will consist of an initial 60 minute session for history and physcial examination as soon as possible after child has been found in the CLandestine laboratory and will be followed up by a 2 hour session within 1 week to complete the developmental assessments.
Intervention code [1] 284024 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286284 0
Positive Methamphetamine levels on urine toxicology screen
Timepoint [1] 286284 0
At 12 months of assessing all children found in clandestine methamphetamine laboratories during that time
Secondary outcome [1] 295516 0
Positive urine levels for other illicit drugs
Timepoint [1] 295516 0
At 12 months of assessing all children found in clandestine methamphetamine laboratories during that time
Secondary outcome [2] 295517 0
Any reported respiratory or neurological symptoms known to be caused by exposure to methamphetamine or the chemicals used in its manufacture. Each patient will be assessed by a standardised proforma including a check list of symptoms that will be checked off.
Timepoint [2] 295517 0
At 12 months of assessing all children found in clandestine methamphetamine laboratories during that time
Secondary outcome [3] 295518 0
Abnormal liver function tests
Timepoint [3] 295518 0
At 12 months of assessing all children found in clandestine methamphetamine laboratories during that time
Secondary outcome [4] 295519 0
Any indicators of physical or sexual abuse or neglect
Timepoint [4] 295519 0
At 12 months of assessing all children found in clandestine methamphetamine laboratories during that time
Secondary outcome [5] 295520 0
Developmental or cognitive assessment below expected level for age. In 0-5 year old this will be via a Griffiths Developmental Scales Assessment, in 5-16 years this will be via the WPPSI and WISC tools.
Timepoint [5] 295520 0
At 12 months of assessing all children found in clandestine methamphetamine laboratories during that time

Eligibility
Key inclusion criteria
1. Consecutive children discovered in raided clandestine methamphetamine laboratories or known to have been in the laboratory within the last 7 days
2. Children aged 0 - 16
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Child has not been in or near the Clandestine Methamphetamine laboratory for the past 7 days
2. Child over 16 years
3. Consent not obtained

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284505 0
Hospital
Name [1] 284505 0
Princess Margaret Hospital
Country [1] 284505 0
Australia
Primary sponsor type
Individual
Name
Dr Sharon Hawkrigg
Address
Princess Margaret Hospital
Roberts Rd
Subiaco
WA 6008
Country
Australia
Secondary sponsor category [1] 283436 0
Individual
Name [1] 283436 0
Clinical A/Prof Peter Winterton
Address [1] 283436 0
Princess Margaret Hospital
Roberts Rd
Subiaco
WA 6008
Country [1] 283436 0
Australia
Other collaborator category [1] 260439 0
Individual
Name [1] 260439 0
Dr Louise Houliston
Address [1] 260439 0
Princess Margaret Hospital
Roberts Rd
Subiaco
WA 6008
Country [1] 260439 0
Australia
Other collaborator category [2] 260440 0
Individual
Name [2] 260440 0
Dr Geraldine Goh
Address [2] 260440 0
Princess Margaret Hospital
Roberts Rd
Subiaco
WA 6008
Country [2] 260440 0
Australia
Other collaborator category [3] 260441 0
Individual
Name [3] 260441 0
Dr Alice Johnson
Address [3] 260441 0
Princess Margaret Hospital
Roberts Rd
Subiaco
WA 6008
Country [3] 260441 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286487 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 286487 0
Roberts Rd
Subiaco
WA 6008
Ethics committee country [1] 286487 0
Australia
Date submitted for ethics approval [1] 286487 0
06/02/2012
Approval date [1] 286487 0
Ethics approval number [1] 286487 0

Summary
Brief summary
We propose to see every child, under the age of 16, who has been found in a Clandestine Methamphetamine laboratory, or who is known to have been in this illegal site in the last 7 days. As the Clan Labs are raided we will liaise with WA Police and Department for Child Protection to assess these children. Each child will receive a thorough physical examination, urine toxicology screen, general bloods including liver function test, and a developmental or cognitive assessment. It is our aim to describe the health effects that potentially arise in children exposed to the methamphetamine and toxic chemicals that are used in the illegal manufacture of this drug. We will describe symptoms, abnormal examination findings, developmental and cognitive functioning and report on positive toxicology screens in these children so that we can better understand the health and medical needs of this population, which is unfortunately on the increase as more illegal labs are found around WA. We ultimately plan to devise a protocol for asessment of these children that can be followed Australia wide.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33628 0
Address 33628 0
Country 33628 0
Phone 33628 0
Fax 33628 0
Email 33628 0
Contact person for public queries
Name 16875 0
Dr Sharon Hawkrigg
Address 16875 0
Princess Margaret Hospital
Roberts Rd
Subiaco
WA 6008
Country 16875 0
Australia
Phone 16875 0
+61 8 9340 8646
Fax 16875 0
+61 8 9340 8822
Email 16875 0
[email protected]
Contact person for scientific queries
Name 7803 0
Clinical A/Professor Peter Winterton
Address 7803 0
Princess Margaret Hospital
Roberts Rd
Subiaco
WA 6008
Country 7803 0
Australia
Phone 7803 0
+61 8 9340 8646
Fax 7803 0
+61 8 93408822
Email 7803 0
[email protected]

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.