Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001214628
Ethics application status
Approved
Date submitted
7/11/2014
Date registered
18/11/2014
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tooth and Lung Sickness in Murri Medical Kids
Scientific title
The respiratory and oral health of urban children aged less than 5 years
Secondary ID [1] 285609 0
NIL
Universal Trial Number (UTN)
Nil
Trial acronym
TLSiMMKids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Health 293458 0
Oral Health 293459 0
Condition category
Condition code
Respiratory 293738 293738 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 293739 293739 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 293792 293792 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Epidemiological, environmental, cultural, social, economic and microbiological determinants of health.
Children are enrolled at the time of presentation for any reason and followed monthly for a period of 12 months. If a child develops an ARI they are followed weekly for 28 days and parents complete a daily cough diary. Demographic, clinical, social, environmental, cultural and economic factors are collected via researcher-administered questionnaires, clinical histories and datasets, telephone interviews or home visits if required. Multivariable modelling will be used to examine the relationship between potential explanatory factors and ARI incidence and outcomes.
Intervention code [1] 290565 0
Not applicable
Comparator / control treatment
Not applicable. Exposures will be compared between children who do and do not develop respiratory/dental health diseases
Control group
Active

Outcomes
Primary outcome [1] 293540 0
Acute respiratory infection: For the purpose of this study, an ARI is defined as any acute illness (ie less than 14 days duration) with cough as symptom.Children that present with ARI or develop ARI during the study period will have weekly follow-up for, four weeks including weekly nasal swabs, and parent completed cough diary cards.
Timepoint [1] 293540 0
Any episode within 12 months of enrolment
Secondary outcome [1] 311293 0
Chronic cough.
chronic cough (defined as > 4 weeks duration) and/or hospitalisation for ARI.
Timepoint [1] 311293 0
each child on the study is followed for 12 months
28 days post onset of acute respiratory illness if a child has a persistent cough at day 28, he/she will be reviewed by a paediatric respiratory fellow. Once seen by the paediatric respiratory fellow, if cough resolved the child will go back into the study on monthly follow ups. If cough not resolved at time of paediatric respiratory fellow review child will stay on weekly follow up until any further investigations by paediatric respiratory fellow are completed once completed child will go back onto monthly follow up.
Secondary outcome [2] 311294 0
Dental caries.
at enrolment a oral health screen questionnaire is completed by research staff and a stage of dentition questionnaire is completed by dentist or oral hygiene therapist
Timepoint [2] 311294 0
Point prevalence on enrolment
Secondary outcome [3] 311295 0
Direct and indirect cost of acute respiratory illness.
To calculate the direct and indirect economic cost of ARI in urban children to the family, community and health-care sectors. Economic endpoints will include both direct and indirect costs for ARI incurred as follows
Costs incurred by the Primary health care service
Costs incurred by the family
Costs incurred by other aspects of the health sector
Costs borne by other sectors of the economy
Timepoint [3] 311295 0
Total cost calculated over 12 months of active study period
Secondary outcome [4] 311296 0
Nasal carriage of respiratory viruses and bacteria.
Nasal swabs are tested for 7 bacteria and 17 viruses via multiplex PCR methods at the Queensland Paediatric Infectious Diseases Laboratory. Descriptive statistics were used to estimate the prevalence of respiratory symptoms and nasal carriage of 7 bacteria and 17 viruses
Timepoint [4] 311296 0
At baseline, monthly for 12 months and weekly during an acute respiratory illness episode.
Participants will be in the study for 12 months following enrolment.
Monthly routine follow-up for 12 months includes,Determine willingness to continue in the study,completion of monthly study questionnaire,collection of monthly nasal swab,collection of any relevant clinical data from medical records at the medical centre or hospital if applicable.

Eligibility
Key inclusion criteria
Aged less than 5 years
Registered with Murri Medical Health Services
Not moving from study area in next 12 months
Minimum age
0 Days
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Broadly, descriptive and analytical statistical methods will be utilised including univariate and multivariate logistic and Poisson regression to identify independent predictors of study endpoints. Demographic, clinical, laboratory, socio-economic and risk factor data will be tabulated and expressed as proportions and/or means of the selected characteristics with the corresponding 95% Confidence Intervals (CI).
Economic analyses will be done according to established methods , including detailed subanalyses of data that account for epidemiological, social, cultural, risk factor and microbiological variables.

The primary analysis will be the incidence density of ARI over a 12-month period. Differences in demographic, clinical, laboratory and risk factor data between children who do and do not develop ARI will be assessed by the normal test for comparisons of means and Chi square tests for comparison of proportions. The incidence of ARI and the predictors for episodes will be assessed assuming a Poisson distribution and multivariate analyses performed using Poisson regression methods. The denominator will be child weeks of observation, with the number of days of ARI experienced for each child removed from person-time at risk calculations.

To estimate the cost of ARI illness, the costing approach will involve following three steps a) Identification of the appropriate resources used, b) Measurement of resources used; and c) valuation of such resources used. Identification of the resources or inputs used, such as health care personnel, transport, consumables, will be guided by the ARI clinical or care pathway, which will be used to identify key care activities and associated unit costs. The pathway will reflect the purpose of the exercise, identify all the components or elements of the program/service in a linear manner, and may involve disease progressions. Some or all of the following type of activities will be included in the costing, which may differ from costs in non-ACCHS services: Co-payments for the pharmaceutical products; transport of clients to and from clinic /or services, social and cultural issue that clinic staff with on behalf of client’s e.g. economic hardship, legal issues. The units of measure of costing data will then be combined with the unit costs to estimate the cost of each activity. The costs of the activities will be aggregated to estimate the cost of illness

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/02/2013
Actual
14/02/2013
Date of last participant enrolment
Anticipated
30/11/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8878 0
4510 - Caboolture

Funding & Sponsors
Funding source category [1] 290204 0
Government body
Name [1] 290204 0
NHMRC
Country [1] 290204 0
Australia
Funding source category [2] 290205 0
Charities/Societies/Foundations
Name [2] 290205 0
Children's Hospital Foundation
Country [2] 290205 0
Australia
Funding source category [3] 290206 0
Government body
Name [3] 290206 0
Queensland Government Smart Futures Fellowship
Country [3] 290206 0
Australia
Funding source category [4] 290207 0
University
Name [4] 290207 0
The University of Queensland Foundation Research Excellence Award
Country [4] 290207 0
Australia
Funding source category [5] 290208 0
University
Name [5] 290208 0
Queensland University of Technology
Country [5] 290208 0
Australia
Primary sponsor type
Hospital
Name
The Lady Cilento Children's Hospital
Address
53 Raymond Terrace
South Brisbane, Queensland 4101
Country
Australia
Secondary sponsor category [1] 288915 0
None
Name [1] 288915 0
Address [1] 288915 0
Country [1] 288915 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291915 0
Queensland Children's Health Services Human Research Ethics Committee
Ethics committee address [1] 291915 0
Ethics committee country [1] 291915 0
Australia
Date submitted for ethics approval [1] 291915 0
Approval date [1] 291915 0
04/12/2012
Ethics approval number [1] 291915 0
HREC/12/QRCH/169

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

Contacts
Principal investigator
Name 52574 0
Dr Kerry-Ann O'Grady
Address 52574 0
Level 7, Centre for Children's Health Research, 62 Graham Street South Brisbane Queensland 4101
Country 52574 0
Australia
Phone 52574 0
61 7 30697270
Fax 52574 0
Email 52574 0
[email protected]
Contact person for public queries
Name 52575 0
Kerry Hall
Address 52575 0
Level 7, Centre for Children's Health Research, 62 Graham Street South Brisbane Queensland 4101
Country 52575 0
Australia
Phone 52575 0
61 7 0424359347
Fax 52575 0
Email 52575 0
[email protected]
Contact person for scientific queries
Name 52576 0
Kerry-Ann O'Grady
Address 52576 0
Level 7, Centre for Children's Health Research, 62 Graham Street South Brisbane Queensland 4101
Country 52576 0
Australia
Phone 52576 0
61 7 30697270
Fax 52576 0
Email 52576 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
SourceTitleYear of PublicationDOI
EmbaseUpper airway viruses and bacteria in urban Aboriginal and Torres Strait Islander children in Brisbane, Australia: A cross-sectional study.2017https://dx.doi.org/10.1186/s12879-017-2349-1
EmbaseHealth service utilisation amongst urban Aboriginal and Torres Strait Islander children aged younger than 5 years registered with a primary health-care service in South-East Queensland.2018https://dx.doi.org/10.1111/jpc.13812
EmbaseThe cost of acute respiratory infections with cough among urban aboriginal and torres strait islander children.2018https://dx.doi.org/10.3389/fped.2018.00379
N.B. These documents automatically identified may not have been verified by the study sponsor.