Prevention of Environmental Tobacco Smoke Exposure in Children 0-12 Months Old
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 participant's background, pregnancy and family history, tobacco use and exposure to other people's 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...
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Prevention of Environmental Tobacco Smoke (ETS) Exposure to Children, Ages 0-12 Months|
- Infant ETS exposure 1)Maternal reports of infant ETS exposure at home and 2) Infant urinary cotinine levels.
- Household ETS exposure levels, and maternal salivary cotinine levels.
|Study Start Date:||July 2005|
|Study Completion Date:||May 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340106
|United States, District of Columbia|
|GW University Medical Center|
|Washington, District of Columbia, United States, 20037|
|Washington, District of Columbia, United States|