Reduction of Tobacco Exposure in Pregnancy and Infancy

减少怀孕期和婴儿期的烟草接触

• 批准号: 6895784
• 负责人: AYMAN A EL-MOHANDES
• 金额: $ 76.34万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-06-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6895784
• 关键词: behavior therapy; clinical research; clinical trials; combination therapy; cooperative study; disease /disorder prevention /control; embryo /fetus toxicology; human morbidity; human subject; human therapy evaluation; infant human (0-1 year); infant mortality; maternal behavior; mother /infant health care; nicotine replacement; passive smoking; patient oriented research; perinatal; pregnancy; prenatal care; smoking; smoking cessation; tobacco abuse

DESCRIPTION (provided by applicant): The GWUMC investigators intend to collaborate with investigators from other sites in this cooperative agreement towards the goal of the NICHD to examine ways to maximize health and healthy behaviors in a minority population of mothers and children. Smoking during pregnancy continues to be a significant public health problem and is the foremost preventable cause of perinatal morbidity and mortality. Strong evidence exists for adverse effects on the mother, the fetus and the infant. The focus of this application is to address the risk of nicotine exposure to the fetus and during infancy, this risk factor is considered a continuum impacting both health and development in later life. The GWUMC investigators are submitting two concept papers that aim to test the efficacy of innovative intervention methods tailored to reduce fetal and infant exposure to nicotine secondary to maternal smoking and environmental tobacco exposure. The specific aims of the first concept entitled, "The Efficacy of Nicotine Replacement Therapy to Reduce the Risk of Nicotine Exposure in Pregnant Minority Smokers" include: #1- Conduct a qualitative study among pregnant participants to identify barriers and facilitators of using transdermal nicotine patches as a method to quit smoking while pregnant. #2- Conduct a randomized clinical trial to determine the efficacy of a behavioral intervention plus transdermal nicotine compared with a behavioral intervention only among pregnant minority women who are heavy smokers. The specific aims of the second proposed concept entitled, "Prevention of Environmental Tobacco Smoke (ETS) Exposure in Children Age 0-12 Months" include: #1- Assess the frequency and types of health effects, major and minor, associated with prenatal and postpartum exposure to tobacco smoke products (TSP) and environmental tobacco smoke (ETS) among infants. #2- Develop and test the efficacy of a brief, clinic-based intervention to prevent ETS exposure during infancy that is consistent with clinical practice guidelines. The George Washington University Medical Center with its Schools of Medicine and Health Sciences and School of Public Health and Health Services and its active clinical and research sites is a suitable environment to investigate this significant public health problem in collaboration with other academic sites in the district. The investigators collaborating on this application cover a wide s spectrum of expertise in pediatrics, neonatal medicine, high-risk maternal and fetal medicine, pharmacology, health behavior and clinical psychology. Through this application they will demonstrate a strong academic track record in the area of interest and a track record of effective collaboration during phases I and II of the NIH-DC Initiative to Reduce Infant Mortality.

描述（由申请人提供）：GWUMC调查人员打算与其他站点的调查人员合作，以这一合作协议中的调查人员达成NICHD的目标，以研究在少数母亲和儿童中最大化健康和健康行为的方法。怀孕期间的吸烟仍然是一个重大的公共卫生问题，这是围产期发病率和死亡率的可预防原因。有强有力的证据表明对母亲，胎儿和婴儿的不利影响。该应用的重点是解决尼古丁暴露于胎儿的风险，在婴儿期间，这种危险因素被认为是影响后来健康和发展的连续性。 GWUMC研究人员正在提交两篇概念论文，旨在测试量身定制的创新干预方法的功效，以减少胎儿和婴儿暴露于孕产妇吸烟和环境烟草暴露的尼古丁。第一个概念的具体目的为“尼古丁替代疗法的疗效降低孕妇吸烟者尼古丁暴露的风险”包括：＃1-在怀孕的参与者中进行定性研究，以识别使用透经尼古丁斑块作为戒烟的方法，以识别障碍和促进者，以戒烟。 ＃2-进行一项随机临床试验，以确定行为干预加上透皮尼古丁的疗效，而仅在吸烟者的怀孕少数妇女中进行行为干预。第二个拟议概念的具体目的标题为“预防0-12个月儿童的环境烟草烟雾（ETS）暴露”包括：＃1-评估健康效应的频率和类型，主要和未成年人的频率和类型，与烟草烟（TSP）和环境烟草（ETS）相关的产前和产后与烟草（ETS烟）相关的频率和次要效果。 ＃2-开发和测试简短的基于诊所的干预措施的功效，以防止在婴儿期的ETS暴露，这与临床实践指南一致。乔治华盛顿大学医学中心及其医学和健康科学学院以及公共卫生和健康服务学院及其活跃的临床和研究地点是一个合适的环境，可与该地区的其他学术地点合作调查这一重大公共卫生问题。该应用程序合作的研究人员涵盖了儿科，新生儿医学，高风险孕产妇和胎儿医学，药理学，健康行为和临床心理学方面的广泛专业知识。通过此应用程序，他们将在感兴趣领域展示出强大的学术记录，并在NIH-DC倡议的第I和II阶段有效合作的记录，以降低婴儿死亡率。