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This study has the ability to provide contemporary Canadian data on the two of the most important outcome measures for effectiveness of rotavirus vaccine: hospital admissions and emergency department visits. The extended time period that already exists prior to vaccine implementation (2005 to 2017) will provide longterm baseline data with which to compare disease burden from 2012 to 2022.
The major advantages to this study are that surveillance occurs at the same hospitals and the same methodology and CRF has been used since 2005. This will ensure reliability and consistency in the surveillance study. The national data set captures patients from age group 0 to 16 years in 12 centers across the country. The retrospective and prospective studies will be in a unique position to capture all children admitted to the 12 pediatric hospitals in Canada. Since reliance on discharge codes alone may underestimate gastroenteritis due to rotavirus, laboratory surveillance coupled with medical record review will ensure the complete capture of the true disease burden. Data on the health status of children will facilitate the evaluation of children who are medically fragile for which rotavirus infections may be more significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotavirus | - Children (0-16 years of age)admitted to hospital (through to December 31, 2020) |
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| Measure | Description | Time Frame |
|---|---|---|
| - Changes in rotavirus hospitalization rates in 12 pediatric hospitals in Canada pre- and post rotavirus vaccine implementation within publicly funded provincial programs | Described In the title | Patients are identified on admission starting January 1, 2018. The surveillance period begins when rotavirus is identified and continues until the patients are discharged (average 3-4 days). The study end date is December 31, 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| - The number of hospital acquired rotavirus infections in children compared pre- and post immunization burden across the network. | Described in the title | Patients are enrolled when rotavirus is identified on a hospitalized patient. The patient is followed until discharge or symptoms of infection have ceased (average 5 days). Enrolment starts January 1, 2012 and ends December 31, 2020. |
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There are two parts to this criteria- Hospital admission surveillance (to December 31, 2019); and genotype surveillance (to December 31, 2020)
Hospital admission surveillance:
Inclusion Criteria:
Exclusion criteria
Rotavirus Genotype Surveillance - on stool sample already obtained for hospital admission purposes (not additional for the surveillance).
- Rotavirus identification: Rotavirus identification at sites will be accomplished by rotavirus antigen detected by EIA (Enzyme Immuno Assay) or electron microscopy.
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Children age 0-16 admitted to the participating IMPACT hospitals (to December 31, 2020) with confirmation of positive stool samples.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Le Saux, MD | Contact | 613-737-7600 | 2651 | lesaux@cheo.on.ca |
| Melanie Laffin Thibodeau | Contact | (613) 526-9397 | 239 | melaniel@cps.ca |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Le Saux, MD | Children's Hospital of Eastern Ontario | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Recruiting | Calgary | Alberta | T3B 6A8 | Canada |
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| Label | URL |
|---|---|
| IMPACT general web site | View source |
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| - The most common rotavirus genotypes in hospitalized patients | Described in the title | Stool specimens from 2012 to 2020 will be collected at the time of laboratory diagnosis. Collection of isolates starts January 1, 2012 and continues to December 2020. |
| Stollery Children's Hospital | Recruiting | Edmonton | Alberta | T6G 1C9 | Canada |
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| BC Children's Hospital | Recruiting | Vancouver | British Columbia | V6H 3V4 | Canada |
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| Winnipeg Children's Hospital | Recruiting | Winnipeg | Manitoba | R3E 3P4 | Canada |
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| Janeway Children's Health and Rehabilitation Center | Recruiting | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
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| IWK Health Centre | Recruiting | Halifax | Nova Scotia | B3K6R8 | Canada |
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| Children's Hospital of Eastern Ontario | Recruiting | Ottawa | Ontario | K1H 8L1 | Canada |
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| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| Montreal Children's Hospital | Recruiting | Montreal | Quebec | H3H 1P3 | Canada |
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| CHU Sainte-Justine Hospital | Recruiting | Montreal | Quebec | H3T 1C5 | Canada |
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| Centre Mère-Enfant de Québec -Pavillon CHUL | Recruiting | Ste Foy | Quebec | G1V 4G2 | Canada |
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| Royal University Hospital | Recruiting | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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