Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035685
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2002-05-04
Brief Title:
Exposure of Children With Asthma to Household Environmental Tobacco Smoke
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
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:
To examine whether or not primary school-aged children with asthma from low-income households have lower household environmental tobacco smoke ETS exposure than matched control children
Detailed Description:
BACKGROUND
Children with asthma are particularly vulnerable to environmental tobacco smoke ETS However despite this special vulnerability to ETS children with asthma are at least as likely to live in smoking households as are healthy children Controversy exists however about whether or not the smoking members of households with children with asthma use specific strategies to reduce the harmful effects of their smoking on their children more than the smoking members of households of healthy children
DESIGN NARRATIVE
The case-control study examines whether or not primary school-aged children with asthma from low-income households have lower household ETS exposure than matched control children Household ETS exposure will be measured by both objective monitoring specifically passive nicotine dosimeters and child cotinine assays the primary hypothesis and maternal-report the secondary hypothesis Ninety children with physician diagnosed asthma and smoking mothers will be matched by age gender raceethnicity and other relevant variables to 90 healthy children All children will be recruited from Metro Denver clinics providing services to low-income underserved populations The sample will contain equal numbers of African Americans Hispanics and Whites Recruitment will target low-income populations due to their increased prevalence of and associated morbidity from both asthma and tobacco smoking Specific household smoking behaviors as reported by mothers will be examined for association with household nicotine and child cotinine levels Finally a set of carefully chosen measures will be examined in tertiary exploratory analyses to help understand clarify and contextualize the observed results
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Children with asthma are particularly vulnerable to environmental tobacco smoke ETS However despite this special vulnerability to ETS children with asthma are at least as likely to live in smoking households as are healthy children Controversy exists however about whether or not the smoking members of households with children with asthma use specific strategies to reduce the harmful effects of their smoking on their children more than the smoking members of households of healthy children
DESIGN NARRATIVE
The case-control study examines whether or not primary school-aged children with asthma from low-income households have lower household ETS exposure than matched control children Household ETS exposure will be measured by both objective monitoring specifically passive nicotine dosimeters and child cotinine assays the primary hypothesis and maternal-report the secondary hypothesis Ninety children with physician diagnosed asthma and smoking mothers will be matched by age gender raceethnicity and other relevant variables to 90 healthy children All children will be recruited from Metro Denver clinics providing services to low-income underserved populations The sample will contain equal numbers of African Americans Hispanics and Whites Recruitment will target low-income populations due to their increased prevalence of and associated morbidity from both asthma and tobacco smoking Specific household smoking behaviors as reported by mothers will be examined for association with household nicotine and child cotinine levels Finally a set of carefully chosen measures will be examined in tertiary exploratory analyses to help understand clarify and contextualize the observed results
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL068828 | NIH | None | httpsreporternihgovquickSearchR01HL068828 |