Neurodevelopmental, Health, and Economic Outcomes at Preschool Age in Former Very Preterm Infants Randomized to An Economic Intervention to Support Mother's Own Milk
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Cognition
研究概览
简要总结
This study will evaluate neurodevelopmental, health, and economic outcomes in preschool children born very preterm that participated in a randomized trial of an economic intervention designed to increase breastmilk feedings while they were in the neonatal intensive care unit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child was enrolled in ReDiMOM Child is alive
排除标准
- •Child is not alive
研究组 & 干预措施
ReDiMOM
Participants that were previously subjects in the ReDiMOM RCT (NCT04540575)
干预措施: This is a an observational prospective cohort study of a previous interventional trial (NCT04540575) (Other)
结局指标
主要结局
Cognition
时间窗: At 5-6 years of age
Cognitive outcome tested by the Wechsler Preschool and Primary Scale of Intelligence
Societal costs
时间窗: Through 6 years of age
Societal costs will be defined as the sum of healthcare, education, family, and ReDiMOM intervention costs from birth to ages 6 years of age. Data will be obtained from ReDiMOM RCT intervention costs (ReDiMOM study database), healthcare costs (Rush data warehouse), early intervention therapies, Medicaid claims, and family costs (questionnaires).
次要结局
- Blood pressure(Through 6 years of age)
- Adiposity(Through 6 years of age)
- Respiratory Health(Through 6 years of age)
- Motor function(Through 6 years of age)
- Behavior(Through 6 years of age)
- Executive functioning(Through 6 years of age)
- Growth(Through 6 years of age)
- Health-related quality of life(Through 6 years of age)