Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340106
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Prevention of Environmental Tobacco Smoke Exposure in Children 0-12 Months Old
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prevention of Environmental Tobacco Smoke ETS Exposure to Children Ages 0-12 Months
Status:
COMPLETED
Status Verified Date:
2011-05-18
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:
This study will 1 test the effectiveness of a program to prevent the exposure of infants to environmental tobacco smoke and 2 evaluate the health effects associated with prenatal and postpartum exposure to tobacco smoke products and environmental tobacco smoke among infants
African-American and Hispanic women who are 18 years of age or older and who are between 28 and 35 weeks pregnant may be eligible for this study Participants complete an interview and home visit assessment and are then randomly assigned to participate in Program A or Program B of the study as follows
Program A Involves discussions with an Infant Health Advisor about parenting skills to promote child safety and infant growth and development such as ways to prevent childhood injuries caused by falls poisons and other hazards
Program B Involves discussions with an Infant Health Advisor about ways to prevent infant tobacco smoke exposure such as how to adopt smoke-free household rules in the home and how to work with friends and family members to prevent the baby from being exposed to tobacco smoke In addition participants who smoked cigarettes before becoming pregnant or while pregnant are given advice on how to quit smoking and how to remain a non-smoker once the baby is born
Participants come to the clinic four times- once during a regularly scheduled prenatal visit and again when the baby is 6 weeks 4 months and 6 months old - to see the Infant Health Advisor for the activities described above in Program A or Program B Between visits the Advisor calls the participant to check on her progress regarding the program objectives In addition the study involves the following for all participants
Telephone interview during the week after joining the study to obtain information on participants background pregnancy and family history tobacco use and exposure to other peoples cigarette smoke during pregnancy strategies to reduce tobacco use and exposure stressful life events drug and alcohol use during pregnancy and sources of social support Similar interviews are repeated when the baby is 6 weeks old and again when the baby is 4 months 6 months and 12 months old
Home visit about 1 week after entering the study to check the home for possible safety hazards to the baby and to place one or more nicotine air monitors small plastic objects that measure the amount of tobacco smoke in the air of each room The home visitor returns a week late
African-American and Hispanic women who are 18 years of age or older and who are between 28 and 35 weeks pregnant may be eligible for this study Participants complete an interview and home visit assessment and are then randomly assigned to participate in Program A or Program B of the study as follows
Program A Involves discussions with an Infant Health Advisor about parenting skills to promote child safety and infant growth and development such as ways to prevent childhood injuries caused by falls poisons and other hazards
Program B Involves discussions with an Infant Health Advisor about ways to prevent infant tobacco smoke exposure such as how to adopt smoke-free household rules in the home and how to work with friends and family members to prevent the baby from being exposed to tobacco smoke In addition participants who smoked cigarettes before becoming pregnant or while pregnant are given advice on how to quit smoking and how to remain a non-smoker once the baby is born
Participants come to the clinic four times- once during a regularly scheduled prenatal visit and again when the baby is 6 weeks 4 months and 6 months old - to see the Infant Health Advisor for the activities described above in Program A or Program B Between visits the Advisor calls the participant to check on her progress regarding the program objectives In addition the study involves the following for all participants
Telephone interview during the week after joining the study to obtain information on participants background pregnancy and family history tobacco use and exposure to other peoples cigarette smoke during pregnancy strategies to reduce tobacco use and exposure stressful life events drug and alcohol use during pregnancy and sources of social support Similar interviews are repeated when the baby is 6 weeks old and again when the baby is 4 months 6 months and 12 months old
Home visit about 1 week after entering the study to check the home for possible safety hazards to the baby and to place one or more nicotine air monitors small plastic objects that measure the amount of tobacco smoke in the air of each room The home visitor returns a week late
Detailed Description:
ETS exposure is a major public health concern and tobacco use is one of the 10 Healthy People 2010 leading health indicators Despite the body of evidence showing the adverse effects of in-utero and postnatal exposure to tobacco smoke products TSP and environmental tobacco smoke ETS to the respiratory health in children studies continue to be needed to elucidate when TSP exposure causes the greatest damage possible mechanisms that underlie the damage and how harm to the respiratory system of infants and vulnerable children can be prevented and while some efforts to reduce prenatal and childhood ETS exposure over the past decade have been successful there is a paucity of randomized controlled intervention studies in the literature targeting ETS exposure reduction among infants age 0-12 months Moreover the effectiveness of ETS exposure prevention interventions in reducing the occurrence or severity of health symptoms and outcomes has rarely been systematically evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CH-N211 | None | None | None |