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NCT00340106 · ClinicalTrials.gov registry record · Phase 2
Prevention of Environmental Tobacco Smoke Exposure in Children 0-12 Months Old
A Phase 2 study of Environmental Tobacco Smoke (ETS), sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 375
- Enrollment target
- 2
- Study locations
NCT00340106 is a Phase 2 study of Environmental Tobacco Smoke (ETS) that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 375 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT00340106, a Phase 2 study of Environmental Tobacco Smoke (ETS), has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 375 participants
- Enrollment target
- 2
- Study locations
Study 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 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
Conditions Studied
Interventions
- BEHAVIORAL Counseling
Study Locations (2)
District of Columbia
- GW University Medical Center - Washington D.C.
- Providence Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2005-07-25 |
| Est. Completion | 2010-05-18 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00340106
The ClinicalTrials.gov registry entry for NCT00340106 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Environmental Tobacco Smoke (ETS) appearing as the primary indexed condition, and to 1 intervention - of which Counseling is the first listed.
NCT00340106 reports 2 study locations spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00340106 about?
NCT00340106 is a clinical study titled "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 an...
What is the current status of trial NCT00340106?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 375 participants. The study started on 2005-07-25. Estimated completion is 2010-05-18.
What conditions does trial NCT00340106 study?
This clinical trial studies the following conditions: Environmental Tobacco Smoke (ETS).
What interventions are being tested in trial NCT00340106?
The interventions under investigation include: Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT00340106?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00340106 being conducted?
This trial has 2 study locations across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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