Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000388617
Ethics application status
Approved
Date submitted
28/03/2014
Date registered
10/04/2014
Date last updated
27/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Rhinovirus Study : A bedroom heating intervention to reduce rhinovirus infection in children.
Scientific title
A randomised placebo controlled trial of the effect of heating children's bedrooms for an 8-week period over the colder months of the year on preventing rhinovirus caused colds and reducing symptom severity as measured by parental reported cold symptoms and nasal swabs for determining levels of rhinovirus in the nose.
Secondary ID [1] 284220 0
Nil
Universal Trial Number (UTN)
U111-1136-4538
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of rhinovirus cold infection 291330 0
Condition category
Condition code
Respiratory 291688 291688 0 0
Other respiratory disorders / diseases
Infection 291689 291689 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomly assigned to one of two different interventions - either a 10 minute ultraviolet light (UV) treatment of the walls and surfaces of the child’s bedroom; or a heater is placed in the child’s bedroom for an 8-week period (in April to November), and set to come on at night time to keep the ambient air temperature at 18-22 degrees C. The heaters have thermostat control.
Intervention code [1] 288921 0
Prevention
Comparator / control treatment
The UV light intervention group will act as the placebo control for this RCT because although UV light is a valid method for denaturing viruses and rendering them non-infectious, it is unlikely that the one time application of this treatment at the beginning of the 8 week study period will effectively prevent exposure to viruses in a child's bedroom throughout the entire 8 week study duration. We will therefore disregard the first week's cold symptom data and use data from the second week onwards to act as the control data for this study. We therefore consider the UV group a sham treatment group (placebo) and it will act as the control group for this study.
Control group
Placebo

Outcomes
Primary outcome [1] 291629 0
Reduction in cold symptoms as recorded in cold symptom diaries in the heating intervention group compared to the placebo group. The parent or guardian will fill in the cold symptom diaries for the child participants.
Timepoint [1] 291629 0
Symptom diaries are collected for 8 weeks from the first visit. The first week of data will be discarded during data analysis, and the subsequent 7 weeks of data will be used to give an average cold symptom score per day. We will compare the mean of the average cold symptom scores per day in the intervention group and the control group.
Secondary outcome [1] 307202 0
Fewer rhinovirus positive nasal swabs in the heating group compared to the placebo group in the swab taken at the end of the 8 week intervention period.
Timepoint [1] 307202 0
Nasal swabs will be taken at the beginning and the end of the 8 week intervention period from all participants. Parents will also swab their children's noses when they exhibit symptoms of a cold. One swab will be taken per cold but if the cold lasts more than seven days, another swab will be taken at the start of the next seven days.
Secondary outcome [2] 307360 0
Lower rhinovirus levels in nasal swabs in the heating group compared to the UV (placebo) group.
Timepoint [2] 307360 0
Nasal swabs will be taken at the beginning and the end of the 8 week intervention period from all participants. Parents will also swab their children's noses when they exhibit symptoms of a cold. One swab will be taken per cold but if the cold lasts more than seven days, another swab will be taken at the start of the next seven days.

Eligibility
Key inclusion criteria
At least one cold infection reported in the previous 12 months.
Minimum age
1 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child lives in more than one house. Child regularly sleeps more than 1 full night per week or more than 2 hours per night) in more than one bedroom. Child's bedroom is heated to 20C for more than 12 hours per day.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Our previous HRC programme He Kainga Oranga/ Community Housing and Health Intervention Research Programme HOME Study examined the influence of housing factors and visible household mould on the development of first onset wheezing. We are approaching this group of participants again to see if they are interested in participating in the Rhinovirus Study. We aim to recruit 300 children in total. If we are not able to achieve this number from the HOME Study invitees, we will recruit the additional participants from the community. After screening the participant and determining that they are eligible, the researcher will assign them to either the heating or UV (placebo) intervention groups using a computer generated randomisation programme. The researchers do not know in advance which group the participant will be assigned to, so in this way, allocation to the study groups is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will occur by using a randomisation table created by computer software and applied at the time of enrolment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power, sampling and analysis: The primary outcome will be the total cold symptom score from the child’s symptom diary, excluding week 1. As the symptom scores are recorded daily per child, a generalised hierarchical linear model, will be used to allow for repeated measures in the data. The primary analysis will therefore be the effect of assignment to the intervention group from hierarchical linear model with total cold symptoms per day as the outcome and each child as a repeated measure with an adjustment for season.

Power: Assuming that the mean of children’s mean symptoms score will reduced by 0.75 and that the standard deviation of the children mean symptom score will be 2 after adjusting for season, the study will have 80% power.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/06/2013
Date of last participant enrolment
Anticipated
3/10/2014
Actual
20/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 5872 0
New Zealand
State/province [1] 5872 0
Wellington

Funding & Sponsors
Funding source category [1] 288845 0
Government body
Name [1] 288845 0
Health Research Council (NZ)
Country [1] 288845 0
New Zealand
Primary sponsor type
Individual
Name
Julian Crane
Address
School of Medicine and Health Sciences
University of Otago Wellington
23a Mein Street
Newtown
Wellington
New Zealand 6021
Country
New Zealand
Secondary sponsor category [1] 287537 0
None
Name [1] 287537 0
None
Address [1] 287537 0
None
Country [1] 287537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290716 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 290716 0
Ministry of Health
No.1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 290716 0
New Zealand
Date submitted for ethics approval [1] 290716 0
Approval date [1] 290716 0
22/11/2012
Ethics approval number [1] 290716 0

Summary
Brief summary
This is a randomised control trial (RCT) to investigate whether heating the ambient air in children's bedrooms to at least 18C overnight for an eight week period during the colder months of the year will significantly reduce the number cold symptoms they get due to rhinovirus infection compared to the number of cold symptoms experienced by children in the placebo group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46770 0
Prof Julian Crane
Address 46770 0
Department of Medicine
University of Otago, Wellington
23a Mein Street
Newtown
Wellington 6021
Country 46770 0
New Zealand
Phone 46770 0
+6449185258
Fax 46770 0
Email 46770 0
[email protected]
Contact person for public queries
Name 46771 0
Prof Julian Crane
Address 46771 0
Department of Medicine
University of Otago, Wellington
23a Mein Street
Newtown
Wellington 6021
Country 46771 0
New Zealand
Phone 46771 0
+6449185258
Fax 46771 0
Email 46771 0
[email protected]
Contact person for scientific queries
Name 46772 0
Prof Julian Crane
Address 46772 0
Department of Medicine
University of Otago, Wellington
23a Mein Street
Newtown
Wellington 6021
Country 46772 0
New Zealand
Phone 46772 0
+6449185258
Fax 46772 0
Email 46772 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

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