Randomized Trial of Heat Recovery Ventilators (HRVs) for the Prevention of Severe Lower Respiratory Tract Infection (LRTI) in Inuit Infants in Baffin Region, Nunavut, Canada

ISRCTN	ISRCTN71224182
DOI	https://doi.org/10.1186/ISRCTN71224182
Secondary identifying numbers	PERD-089

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Thomas Kovesi
Scientific

Children's Hospital of Eastern Ontario
401 Smyth Rd
Ottawa
K1H 8L1
Canada

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title	Randomized Trial of Heat Recovery Ventilators (HRVs) for the Prevention of Severe Lower Respiratory Tract Infection (LRTI) in Inuit Infants in Baffin Region, Nunavut, Canada
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Bronchiolitis, Pneumonia
Intervention	Heat Recovery Ventilator versus placebo Heat Recovery Ventilator
Intervention type	Other
Primary outcome measure	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 study start date	15/09/2005
Completion date	15/09/2008

Participant type(s)	Patient
Age group	Child
Lower age limit	0 Years
Upper age limit	2 Years
Sex	Both
Target number of participants	150
Total final enrolment	68
Key inclusion criteria	Inuit infants 0-2 years of age living in eligible communities in Baffin Region, Nunavut, Canada
Key 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.
Date of first enrolment	15/09/2005
Date of final enrolment	15/09/2008

Children's Hospital of Eastern Ontario

Ottawa
K1H 8L1
Canada

Program of Energy Research and Development (Canada)
Government

CANMET Energy Technology Centre - Ottawa
Natural Resources Canada
580 Booth Street
13th floor Haanel Drive
Ottawa
K1A 0E4
Canada

Government

Program of Energy Research and Development (PERD) PERD-089

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2009	09/05/2019	Yes	No

09/05/2019: Publication reference and total final enrolment added.