跳至主要内容
临床试验/NCT01852695
NCT01852695Unknown不适用

A Family Integrated Care Model For The Neonatal Intensive Care Unit: A Cluster Randomised Controlled Trial

Mount Sinai Hospital, Canada15 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
720
试验地点
15
主要终点
Weight Gain

研究概览

简要总结

In the highly technological environment of the modern neonatal intensive care unit (NICU), the infant is physically, psychologically and emotionally separated from its parents. Recognition that this impedes parent- infant interaction and is detrimental to the infant, led to the development of programs such as family centered care, kangaroo care and skin-to-skin care1-3. However, they are based on the common premise that only NICU professionals with special skills can provide care for the infant. Parents are relegated to a supportive role, and some have described themselves as voyeurs who are "allowed" to visit and hold their infants4. Many feel anxious and unprepared to care for their infants after discharge5.

In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a "humane" care model in which parents provided nursing care for the infant (except for administration of IV fluid and medication), while nurses provided teaching and guidance to parents. This resulted in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents and staff [personal communication, Levin,A.]. Building on the Estonian experience, we have developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their families were enrolled in the study. Preliminary results and feedback from parents and healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead to improved outcomes including improved weight gain(paper submitted for publication). This study is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the efficacy of the FIC model in Canada.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
— 至 33 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • < 33 weeks gestational age at birth;
  • On no respiratory support or low level respiratory support (i.e., oxygen by cannula or mask, or continuous positive airway pressure (CPAP);
  • A primary caregiver parent who is willing and able to commit to spending at least 8 hours per day with her/his infant between the hours of 0700 and 2000;
  • Parental consent.

排除标准

  • Palliative care;
  • Major life threatening congenital anomaly;
  • Critical illness (unlikely to survive);
  • On high level of respiratory support (mechanical ventilator, high frequency oscillatory or jet ventilation, extra-corporeal membrane oxygenation)
  • Parental request for early transfer to another hospital;
  • Parental inability to participate (e.g., health, social or language issues that might inhibit their ability to communicate with the healthcare team).

结局指标

主要结局

Weight Gain

时间窗: Day 0-21

Change in weight from enrollment to day 21 following commencement of the intervention

次要结局

  • Weight gain velocity(Day 0-21)
  • Resource Use(Day 0 -week 16)
  • Breastfeeding rate(up to 16 weeks)
  • Parental stress and anxiety(Day 0 and when the infant reaches 35 weeks corrected gestational age)
  • Clinical outcomes (mortality and Nosocomial infection (NI), Necrotizing Enterocolitis (NEC), Bronchopulmonary Dysplasia(BPD), Retinopathy of prematurity(ROP) & Intraventricular haemorrhage(IVH)(up to 16 weeks)
  • Safety(1000 patient days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (15)

Loading locations...

相似试验