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
- 2
- 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
- •For infants :
- •Birth weight at or below 1500 g or gestational age at or below 34 weeks.
- •Any other peri-neonatal condition anticipating NICU specialised care.
- •Admission for at least 7 days
- •Decision to provide full life support.
- •Inclusion Criteria For Adults
- •Willingness to spend at least 6h per day at NICU OR commitment to attend educational sessions
- •Active involvement in care for their infant at least a 7 day-period
- •No intellectual or language barriers[A] to understanding
- •At least one primary caregivers involved in training [B]
- •Signed informed consent
排除标准
- •For Children:
- •Decision not to provide full life support
- •Critical illness unlikely to survive
- •Scheduled for early transfer to another non-FICare hospital (expected hospital stay <7days)
- •Exclusion Criteria for Parents:
- •Intellectual handicaps that makes difficult learning-understanding
- •Communication cannot be established even with translator
- •Mental, psychiatric problems or under legal supervision
- •Newborn under guardianship of social services
- •Lack of parental signed informed consent
研究组 & 干预措施
control intervention
A cohort of patients born at the non-FICare clinical sites (AMC, GU, CLUJ, UHS, and UNZA) from the start of the study (November 2022) to the time assigned to start the intervention. A 3-month washout period will be established for staff training and site readiness.
FICare intervention
FICare implementation model will be demonstrated by setting 5 pilots in non-FICare-experienced NICUs from NL, TR, RO, UK, ZM (AMC, GU, CLUJ, UHS, and UNZA, partners, respectively) and 2 pilots in clinical sites who have recently implemented FICare from ES and NL (SERMAS and OLVG).
干预措施: FICare (Procedure)
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))
- 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))
- Reported adverse event rate per 1000 patients/day(Through study completion (average of 24 months))