A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,223
- 主要终点
- Admission to the Level II/III neonatal care unit or hospital
研究概览
简要总结
To determine the effect of a policy of early maternal-newborn infant discharge (12-24 hours) with a home visit on admission to the Level II/III nursery and hospital admissions and readmissions.
详细描述
This is a randomized controlled trial designed to assess the safety of a policy of early maternal newborn infant discharge compared to a policy of routine discharge 2 to 3 days after delivery. The primary outcome is newborn admissions to the Level II or Level III neonatal care unit or hospital within three days of delivery. Secondary outcomes included admissions and readmissions at 2 weeks, 6 weeks and 6 months following delivery, maternal satisfaction with length of stay and overall birthing experience, lactation continuation rates, maternal anxiety, depression, confidence and family functioning. We applied the American Academy of Pediatrics criteria for early newborn discharge, but planned the analysis by intention to treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All pregnant women enrolling for obstetric care at a large military academic health center
排除标准
- •Planning a move from the area before delivery
- •Multiple gestations
- •Pre-existing maternal diabetes
- •Maternal chronic hypertension
- •Maternal age < 18
结局指标
主要结局
Admission to the Level II/III neonatal care unit or hospital
时间窗: 72 hours
All admissions to the Level II/III neonatal care unit following delivery
次要结局
- Breastfeeding score (5 point Likert scale)(6 months)
- Maternal confidence (Confidence on a Likert scale)(14 days)
- Emergency department visits, clinic visits, or hospital admissions(6 months)
- Maternal satisfaction with overall experience (Likert scale)(14 days)
- Admission to the Level II/III neonatal care unit or hospital(6 months)
- Maternal depression (Generalized Contentment Scale)(14 days)
- Maternal anxiety (State/Trait Anxiety Inventory)(14 days)
- Maternal satisfaction with length of stay (Likert scale)(14 days)
研究者
William H. Barth, Jr., M.D., Col(ret), USAF, MC
Chairman, Department of Obstetrics and Gynecology
59th Medical Wing