NCT00499915已完成不适用
Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Infants Living in Smoke-free Environments.
研究概览
简要总结
Premature infants have a significantly increased risk for developing respiratory illnesses and asthma. Secondhand smoke (SHS) also is clearly associated with increased breathing problems in children, thus exposure to smoke makes it substantially more likely for a premature infant to develop wheezing. The overall goal of this study is to test whether comprehensive asthma education combined with a home-based secondhand smoke reduction program can reduce exposure to smoke and prevent respiratory illness among premature infants. Our hypotheses are:
- More premature infants whose families receive asthma education combined with a SHS reduction intervention will live in smoke-free environments compared to infants receiving only asthma education (control group).
- Caregivers receiving the SHS reduction program will have higher rates of quit attempts and less relapse into smoking compared to caregivers in the control group.
- Infants whose families receive the combined intervention will experience less respiratory illness compared to infants in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≤32 weeks gestation
- •Planned discharge to home from the Neonatal Intensive Care Unit
- •Parent or caregiver must consent to the intervention
- •The first sibling discharged, for twins or infants from a multiple birth pregnancy
排除标准
- •Inability to speak and understand English
- •No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate home)
- •Family residence outside the greater Rochester area (more than 30 miles away)
- •Children in foster care or other situations in which guardian consent cannot be obtained
- •The child having significant medical conditions, including serious heart disease, cystic fibrosis, or other conditions that could interfere with the assessment of respiratory-related outcome measures
结局指标
主要结局
Infants Living in Smoke-free Environments.
时间窗: 5 months post baseline
Infants living in homes with a "home smoking ban" rule
次要结局
- Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.(2, 5, and 7-9 months post baseline)
研究者
Jill Halterman
Associate Professor
University of Rochester
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature InfantsRespiratory InfectionsNCT01390753Fundacion Infant300
招募中
3 期
Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.WheezingPrematureLRTINCT05063149Franciscus Gasthuis500
已完成
3 期
PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm NeonatesBronchopulmonary DysplasiaNCT00623740Assistance Publique - Hôpitaux de Paris523
已完成
不适用
Children's Respiratory and Environmental WorkgroupAllergiesHealthyAsthmaAllergic AsthmaNCT03213184University of Wisconsin, Madison142
已完成
1 期
Open-label Study of Inhaled RVT-1601 in Preterm InfantsRespiratory Morbidities of Prematurity (RMP)NCT04007120Respivant Sciences GmbH8