Early Life Exposures Among Children With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention
研究概览
简要总结
This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition/breastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.
详细描述
During year 3 of the award period, 20 mother-infant dyads will be randomly assigned to either a community-based breastfeeding support group or observation. Acceptability to enrollment, intervention adherence for at least 6 months and preliminary effectiveness will be captured. Biomarkers of inflammation, development of asthma and incidences of pain and/or acute chest syndrome will be compared among the intervention and control groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •mother of infant with sickle cell disease
- •resides within the city of Birmingham, Alabama or in close proximity
排除标准
- •prescribed teratogenic medications
- •no/limited internet access
研究组 & 干预措施
Breastfeeding Intervention Group
Ten mother-infant dyads will be recruited to a six-month, community-based intervention aimed to promote sustained breastfeeding for at least six months among mothers of infants with sickle cell disease. The intervention will include an online, social media-based support group, online educational modules, monthly in-person educational sessions, access to free breast pump rentals, and monthly peer-led home visits by certified Vanderbilt-affiliated Maternal Infant Health Outreach Specialists. We obtain whole blood specimens for analysis of oxidative stress and inflammation at 3, 6, 12 and 24 months.
干预措施: Breastfeeding support group (Behavioral)
Observation Group
A 24 month observation of 10 mother-infant dyads affected by sickle cell disease that initiate breastfeeding. These dyads will observed for breastfeeding exclusivity/dosage and duration. We obtain whole blood specimens for analysis of oxidative stress and inflammation at 3, 6, 12 and 24 months.
干预措施: Observation (Other)
结局指标
主要结局
Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention
时间窗: 6 months
acceptance (number of mothers enrolled/number of mothers approached) and retention (number of mothers to complete 6 month support group intervention/number enrolled)
Preliminary Effectiveness
时间窗: 2 years
Percentage of mothers of infants with sickle cell disease that successful complete 6 months of breastfeeding, comparing the intervention vs. control groups
次要结局
- Asthma(4 year follow up period)
- Acute chest syndrome(4 year follow up period)
研究者
Brandi Pernell
Assistant Professor
University of Alabama at Birmingham