Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04449978
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2020-06-23
Brief Title:
TARGet Kids COVID-19 Study of Children and Families
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
TARGet Kids COVID-19 Study of Children and Families
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The novel coronavirus COVID-19 was declared a global pandemic in March 2020 Early research suggests that children are no more susceptible to COVID-19 infection than adults and that children with confirmed COVID-19 have generally presented with milder symptoms However the impact of COVID-19 among Canadian children remains unclear The prevalence of COVID-19 in children in Canada is currently unknown and no published research exists regarding the risk factors of COVID-19 in children or its potential long-term health effects on physical health or development Using TARGet Kids Canadas largest childrens cohort study with over 11000 children involved the researchers will conduct a longitudinal observational study aimed to evaluate the cumulative incidence of COVID-19 in children and parents differences among infected and uninfected children in terms of age sex and income risk factors of COVID-19 and longer term health effects of COVID-19 among children Given the rapid spread of COVID-19 and the unknown health effects of the virus in children research must be conducted to determine the extent of infections of COVID-19 in children disease severity risk factors for infection and how the virus affects children as they become older
Detailed Description:
The novel coronavirus COVID-19 was declared a global pandemic in March 2020 Early research has suggested that children may experience less severe clinical symptoms than adults and infected children with minimal or no symptoms may be an underrecognized source of community disease transmission COVID-19 infections in children were occurring very early in the epidemic but the impact of COVID-19 infection among children remains unclear The number of COVID-19 infections in children and parents in Canada is unknown and studies have not evaluated the symptom severity of COVID-19 in children and parents risk factors for infection and severe disease and whether current preventive efforts are effective Using TARGet Kids Canadas largest childrens cohort study the researchers will conduct an observational study to evaluate key epidemiological characteristics of COVID-19 among parents and children as well as to determine the spectrum of disease severity seroprevalence risk factors for COVID-19 infection and severe disease effectiveness of social isolation recommendations risk to family members with a COVID-19 infected family member and potential new strategies to prevent COVID-19 infection and minimize disease severity Parents of 1082 existing TARGet Kids participants will be asked to provide a nasal swab from themselves and their child during the pandemic in addition to a respiratory tract symptom checklist Preventive efforts eg social distancing parent-reported illness laboratory-confirmed infections and healthcare encounters eg emergency department visits hospitalizations and ICU care will be measured Children will subsequently be followed through the TARGet Kids cohort study over the next 6 months and long term with interim analyses at 3 months By understanding every stage of COVID-19 infection from prevention to transmission in the community and home to outpatient and hospital care utilization the researchers will rapidly develop new interventions to prevent COVID-19 transmission and minimize disease severity among children and their families Descriptive statistics will be used to determine the prevalence of COVID-19 in healthy children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None