Integrating Families at Neonatal Intensive Care Units for Empowering Them as Primary Caregivres: the Impact of the Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Short-term health infant's outcomes
研究概览
简要总结
International, multi-centre, pluri-cultural, stepped wedge cluster controlled trial, to demonstrate superiority of site tailored 'Family integrated care model'(FICare), that promotes the active participation of the parents as primary caregivers of their infants in neonatal intensive care units (NICU), versus standard NICU care delivery with regards to short-term health outcomes in high-risk newborns with prolonged hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Weeks 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Short-term health infant's outcomes
时间窗: Through study completion (average of 24 months)
proportion of high-risk infants achieving and maintaining adequate growth patterns during NICU admission.
RISEinFAMILY implementation:
时间窗: Through study completion (average of 24 months)
proportion of families completing basic and advanced training levels (observed vs expected).
次要结局
- Proportion of infants diagnosed of (at 36 weeks PMA or discharge): bronchopulmonary dysplasia, oxygen dependency, severe retinopathy of prematurity (grade 3 or need for treatment), nosocomial infection necrotising enterocoli(Through study completion (average of 24 months))
- Reported adverse event rate per 1000 patients/day(Through study completion (average of 24 months))
- Satisfaction and self-care of professionals measured by surveys(Through study completion (average of 24 months))
- Feeding patterns at discharge:(Through study completion (average of 24 months))
- Brestfeeding rates at discharge:(Through study completion (average of 24 months))
- Parental psychological health(Through study completion (average of 24 months))