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 |
| Protocol serial number | PERD-089 |
| Sponsor | Program of Energy Research and Development (Canada) |
| Funder | Program of Energy Research and Development (PERD) PERD-089 |
- Submission date
- 15/08/2005
- Registration date
- 04/11/2005
- Last edited
- 09/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Thomas Kovesi
Scientific
Scientific
Children's Hospital of Eastern Ontario
401 Smyth Rd
Ottawa
K1H 8L1
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Admission to hospital for severe lower respiratory tract infection |
| Key secondary outcome measure(s) |
Effect of Heat Recovery Ventilators on indoor CO2, Air change rate, respiratory symptoms, occupant comfort, and visits to the nursing station for respiratory illness. |
| Completion date | 15/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 2 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Canada
Study participating centre
Children's Hospital of Eastern Ontario
Ottawa
K1H 8L1
Canada
K1H 8L1
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2009 | 09/05/2019 | Yes | No |
Editorial Notes
09/05/2019: Publication reference and total final enrolment added.
