Condition category
Respiratory
Date applied
15/08/2005
Date assigned
04/11/2005
Last edited
08/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Kovesi

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Program of Energy Research and Development (Canada)

Sponsor details

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

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes