Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
2015年2月19日 更新者：William H. Barth, Jr., M.D., Col(ret), USAF, MC、59th Medical Wing
A Randomized Controlled Trial to Assess the Safety and Cost-Effectiveness of Early Maternal Newborn Infant Discharge
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
2223
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- All pregnant women enrolling for obstetric care at a large military academic health center
Exclusion Criteria:
- Planning a move from the area before delivery
- Multiple gestations
- Pre-existing maternal diabetes
- Maternal chronic hypertension
- Maternal age < 18
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Early Discharge Group
If safety criteria were met, women and infants were discharged home from the hospital at 12 to 24 hours after delivery with a planned home health visit within 48 hours of the discharge.
|
Discharge from the hospital between 12-24 hours of life
|
|
有源比较器：Routine Stay Group
Women and newborns were discharged no sooner than 48 hours after delivery and could stay voluntarily up to 72 hours.
|
Discharge of the mother and newborn 2 to 3 days after delivery
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Admission to the Level II/III neonatal care unit or hospital
大体时间：72 hours
|
All admissions to the Level II/III neonatal care unit following delivery
|
72 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Emergency department visits, clinic visits, or hospital admissions
大体时间：72 hours
|
Any unplanned pediatric visit to an emergency room, clinic or a hospital admission
|
72 hours
|
|
Emergency department visits, clinic visits, or hospital admissions
大体时间：14 days
|
Any unplanned pediatric visit to an emergency room, clinic or a hospital admission
|
14 days
|
|
Emergency department visits, clinic visits, or hospital admissions
大体时间：8 weeks
|
Any unplanned pediatric visit to an emergency room, clinic or a hospital admission
|
8 weeks
|
|
Emergency department visits, clinic visits, or hospital admissions
大体时间：6 months
|
Any unplanned pediatric visit to an emergency room, clinic or a hospital admission
|
6 months
|
|
Breastfeeding score (5 point Likert scale)
大体时间：At discharge (12 to 72 hours after delivery)
|
5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle
|
At discharge (12 to 72 hours after delivery)
|
|
Breastfeeding score (5 point Likert scale)
大体时间：14 days
|
5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle
|
14 days
|
|
Breastfeeding score (5 point Likert scale)
大体时间：8 weeks
|
5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle
|
8 weeks
|
|
Breastfeeding score (5 point Likert scale)
大体时间：6 months
|
5 point Likert scale: Only breast, mostly breast, 50/50, mostly bottle, only bottle
|
6 months
|
|
Maternal anxiety (State/Trait Anxiety Inventory)
大体时间：At discharge (12 to 72 hours after delivery)
|
At discharge (12 to 72 hours after delivery)
|
|
|
Maternal anxiety (State/Trait Anxiety Inventory)
大体时间：14 days
|
State/Trait Anxiety Inventory
|
14 days
|
|
Maternal depression (Generalized Contentment Scale)
大体时间：At discharge (12 to 72 hours after delivery)
|
Generalized Contentment Scale
|
At discharge (12 to 72 hours after delivery)
|
|
Maternal depression (Generalized Contentment Scale)
大体时间：14 days
|
Generalized Contentment Scale
|
14 days
|
|
Maternal confidence (Confidence on a Likert scale)
大体时间：At discharge (12 to 72 hours after delivery)
|
Confidence on a Likert scale
|
At discharge (12 to 72 hours after delivery)
|
|
Maternal confidence (Confidence on a Likert scale)
大体时间：14 days
|
Confidence on a Likert scale
|
14 days
|
|
Maternal satisfaction with length of stay (Likert scale)
大体时间：At discharge (12 to 72 hours after delivery)
|
Satisfaction with length of stay on a Likert scale
|
At discharge (12 to 72 hours after delivery)
|
|
Maternal satisfaction with length of stay (Likert scale)
大体时间：14 days
|
Satisfaction with length of stay on a Likert scale
|
14 days
|
|
Maternal satisfaction with overall experience (Likert scale)
大体时间：At discharge (12 to 72 hours after delivery)
|
Satisfaction with overall childbirth experience on a Likert scale
|
At discharge (12 to 72 hours after delivery)
|
|
Maternal satisfaction with overall experience (Likert scale)
大体时间：14 days
|
Satisfaction with overall childbirth experience on a Likert scale
|
14 days
|
|
Admission to the Level II/III neonatal care unit or hospital
大体时间：14 days
|
All admissions to the Level II/III neonatal care unit following delivery
|
14 days
|
|
Admission to the Level II/III neonatal care unit or hospital
大体时间：8 weeks
|
All admissions to the Level II/III neonatal care unit following delivery
|
8 weeks
|
|
Admission to the Level II/III neonatal care unit or hospital
大体时间：6 months
|
All admissions to the Level II/III neonatal care unit following delivery
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：William H Barth, MD、Massachusetts General Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
1997年4月1日
初级完成 (实际的)
2001年1月1日
研究完成 (实际的)
2001年8月1日
研究注册日期
首次提交
2015年2月3日
首先提交符合 QC 标准的
2015年2月19日
首次发布 (估计)
2015年2月26日
研究记录更新
最后更新发布 (估计)
2015年2月26日
上次提交的符合 QC 标准的更新
2015年2月19日
最后验证
2015年2月1日
更多信息
与本研究相关的术语
其他研究编号
- SGO 96-042
- DI950076 (其他赠款/资助编号：Department of Defense Women's Health Intramural Research)
- FWH19960042H (其他标识符：Wilford Hall Medical Center)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.