Status:
COMPLETED
Prevention of Environmental Tobacco Smoke Exposure in Children 0-12 Months Old
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Environmental Tobacco Smoke (ETS)
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ex...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 25 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 18 2010
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00340106
Start Date
July 25 2005
End Date
May 18 2010
Last Update
July 2 2017
Active Locations (2)
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1
GW University Medical Center
Washington D.C., District of Columbia, United States, 20037
2
Providence Hospital
Washington D.C., District of Columbia, United States