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临床试验/NCT02901665
NCT02901665已完成不适用

Impact of Increased Parent Presence in the NICU on Parent & Infant Outcomes

Ann & Robert H Lurie Children's Hospital of Chicago4 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
191
试验地点
4
主要终点
Parent Salivary Cortisols

研究概览

简要总结

The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the Neonatal Intensive Care Unit (NICU). The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence.

详细描述

Family centered care (FCC) is becoming the standard of care in the Neonatal Intensive Care Unit (NICU) and many benefits of FCC programs are reported in the literature. However, the integration of FCC practices remains inconsistent in NICUs and many families do not fully access available FCC supports. As a result NICU families continue to report feelings of powerlessness, stress, depression and lack of confidence in their ability to care for their infants at home. Studies of increased family presence in the NICU (8hours/day and 24/hours/day) have reported promising results for infants and families, but these studies report on programs implemented outside of the US. It is not known whether a program requiring fewer hours/day of parent presence, which may be a better fit with current US family demographics and policies, would demonstrate similar benefits. The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the NICU. The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence. Following informed consent, data will be collected on up to 45 NICU infants and families pre- and post- the intervention for a total sample of up to 90. Infant measures will include Salivary Cortisol levels, Infant weight gain, Length of Stay and Feeding route at discharge as well as rates of Family Visiting, Traditional Holding, Kangaroo Care (KC), and Breastfeeding. Parent measures will include Salivary Cortisol Levels and reported stress using the Parent Stress Scale: NICU. Unit-wide data will also be collected pre- and post- the intervention. Unit wide measures will include rates of Visitation, KC, Breastfeeding, Nosocomial Infections, IV infiltrates, Medication Errors and Incident (SERS) report rates.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Day 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Less than 2 weeks of age
  • Must be admitted to NICU

排除标准

  • Previously discharged home
  • <28 weeks gestation
  • Anticipated hospital stay > 3 months

研究组 & 干预措施

Pre-FCC Intervention

No Intervention

Pre-intervention group. No intervention will be administered.

Post-FCC Intervention

Active Comparator

Following unit-wide implementation of FCC intervention consisting of communicating to families an expectation that they spend 4 hours per day in the NICU with their infants.

干预措施: FCC intervention (Other)

结局指标

主要结局

Parent Salivary Cortisols

时间窗: Throughout duration of NICU stay, an expected average of 4 weeks

Salivary Cortisol levels obtained at admission, every 4 weeks and at discharge

Parent Stress Scale: NICU

时间窗: Throughout duration of NICU stay, an expected average of 4 weeks

Measured at admission and discharge using validated Parent Stress Scale: NICU

Infant Salivary Cortisol

时间窗: Throughout duration of NICU stay, an expected average of 4 weeks

Measured at admission, every 4 weeks and at discharge

次要结局

  • Family Visiting Rate(Throughout duration of NICU stay, an expected average of 4 weeks)
  • Parent Kangaroo Care Rate(Throughout duration of NICU stay, an expected average of 4 weeks)
  • Breastfeeding Rate(Throughout duration of NICU stay, an expected average of 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Horner, PhD

Clinical Nurse Specialist - Developmental Specialist

Ann & Robert H Lurie Children's Hospital of Chicago

研究点 (4)

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