Postpartum Care in the NICU (PeliCaN) Transitions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of participants who have attendance with a primary care provider by 6 months postpartum
研究概览
简要总结
This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HUP postpartum patients who are at least 16 years old at the time their newborns' birth
- •Infant born at HUP
- •Preterm birth <34 weeks
- •English language speaking
排除标准
- •Unable to read or sign informed consent
- •Parents of infants transferred into HUP NICU
- •If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks
- •HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth
结局指标
主要结局
Number of participants who have attendance with a primary care provider by 6 months postpartum
时间窗: 6 months
This will be assessed using the electronic health record and via survey and medical record review of outsider records.
Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum
时间窗: 6 months
This will measured by the PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The symptom severity score ranges from 0-80 with 80 being a worse score.
次要结局
- Difference in Depression scores at 6 months postpartum(6 months)
- Receipt of ACOG-recommended postpartum care by patient's designated provider(12 weeks postpartum)
研究者
Heather Burris
Associate Professor of Pediatrics
University of Pennsylvania