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

Completed · Phase 2

Conditions studied: Environmental Tobacco Smoke (ETS)

In brief

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...

Key facts

Study ID

NCT00340106

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

375

Starts

2005-07-25

Expected to finish

2010-05-18

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• GW University Medical Center — Washington D.C., District of Columbia, United States
• Providence Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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