Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PERD-089
Study information
Scientific title
Acronym
Study hypothesis
Heat Recovery Ventilators, by improving indoor air ventilation and indoor air quality will reduce the incidence of severe lower respiratory tract infection requiring admission to hospital in Inuit infants in Baffin Region, Nunavut.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Bronchiolitis, Pneumonia
Intervention
Heat Recovery Ventilator versus placebo Heat Recovery Ventilator
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Admission to hospital for severe lower respiratory tract infection
Secondary outcome measures
Effect of Heat Recovery Ventilators on indoor CO2, Air change rate, respiratory symptoms, occupant comfort, and visits to the nursing station for respiratory illness.
Overall trial start date
15/09/2005
Overall trial end date
15/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Inuit infants 0-2 years of age living in eligible communities in Baffin Region, Nunavut, Canada
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
150
Participant exclusion criteria
Children with underlying congenital malformations known to increase the risk of LRTI, including congenital lung malformations and congenital heart disease will be excluded from the study, as well as children with underlying conditions known to increase the risk of LRTI, including cystic fibrosis, severe developmental delay, and immunodeficiency. Houses where it is technically impossible to install the HRV will be excluded from the study. Only households providing informed consent will be allowed to participate in the trial.
Recruitment start date
15/09/2005
Recruitment end date
15/09/2008
Locations
Countries of recruitment
Canada
Trial participating centre
Children's Hospital of Eastern Ontario
Ottawa
K1H 8L1
Canada
Funders
Funder type
Government
Funder name
Program of Energy Research and Development (PERD) PERD-089
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary