Prevention of Environmental Tobacco Smoke Exposure in Children 0-12 Months Old

Condition(s) targeted: Environmental Tobacco Smoke (ETS)

Intervention: Counseling (Behavioral)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute of Child Health and Human Development (NICHD)

Overall contact:
Maurice Davis, Phone: (301) 594-9198, Email: md350g@nih.gov

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 later to collect the monitors and ask questions about cigarette smoking by members of the household during the previous week. Similar home visits are repeated when the baby is 6 weeks old, and again when the baby is 6 months, and 12 months old. Collection of saliva samples from the baby's mother upon entering the study, one week later, and again when the baby is 6 weeks, 6 months, and 12 months old to measure participant's exposure to tobacco smoke. Collection of urine samples from the baby's diaper when the baby is 6 weeks, 6 months, and 12 months old to measure the amount of exposure to cigarette smoke during the previous week. Permission for investigators to contact the mother's and the baby's health care provider immediately following delivery, and again when the child is 12 months old to learn more about any birth or delivery complications for the mother or child, and any health problems or medical treatments the baby received since birth. Participants may be contacted within 1 to 2 years after completing the project for a 30-minute telephone interview regarding what they thought about the project and to check on their progress and how the child and family members have been doing since completing the study.

Official title: Prevention of Environmental Tobacco Smoke (ETS) Exposure to Children, Ages 0-12 Months

Study design: Treatment

Primary outcome: Infant ETS exposure 1)Maternal reports of infant ETS exposure at home and 2) Infant urinary cotinine levels.

Secondary outcome: Household ETS exposure levels, and maternal salivary cotinine levels.

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. 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 severity of health symptoms and outcomes has rarely been systematically evaluated.

Minimum age: N/A. Maximum age: 1 Year. Gender(s): Female.

Criteria:

INCLUSION CRITERIA: English-speaking women over age 18, who self-identify as African American, Black or Hispanic, live in the DC metropolitan area, and who have a singleton pregnancy will be enrolled in this study. EXCLUSION CRITERIA: Exclusionary criteria include women reporting diagnosis of major psychiatric illnesses, current incarceration, or suicidal ideation, or who initiate prenatal care after 28 weeks. At postpartum, women who have lost custody of the child, are in withdrawal from addictive substances requiring hospitalization or methadone treatment will be deemed ineligible to remain in the study. Further, all women who report delivery complications requiring a hospital stay of 7 days or longer or the infants' admissions to the NICU (or NICU step down unit) for more than 12 hours, including infant prematurity less than 34 weeks, or infant birth weight less than 1800gm (i. e. 4. 9 pounds) will be considered ineligible to continue in the study.

Maurice Davis, Phone: (301) 594-9198, Email: md350g@nih.gov

GW University Medical Center, Washington, District of Columbia 20037, United States; Recruiting
Susan Blake, Ph.D., Sub-Investigator

Related publications:

Chilmonczyk BA, Palomaki GE, Knight GJ, Williams J, Haddow JE. An unsuccessful cotinine-assisted intervention strategy to reduce environmental tobacco smoke exposure during infancy. Am J Dis Child. 1992 Mar;146(3):357-60.

Starting date: July 2005
Last updated: December 5, 2007