Coached, Coordinated, Enhanced Neonatal Transition (CCENT): A Multi-centre Mixed-methods Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 7
- 主要终点
- Change in Parental Stress
研究概览
简要总结
This study will evaluate a new neonatal follow-up model that offers additional support and coping resources for parents during their child's NICU admission as well as during their transition home. The Coached, Coordinated, Enhanced Neonatal Transition (CCENT) model involves a key worker who will be the primary support for families during the first year of their child's life. The key worker's role involves 1) parental coaching using an Acceptance and Commitment Therapy approach, 2) coordinating care across various levels of care as well as supporting families in system and resource navigation, and 3) provided proactive education targeting normal challenges in caring for a child who required intensive care support. The goal is to improve the psychosocial support and medical care coordination beyond the neonatal intensive care unit as many of the medical and social concerns do not end at the time of discharge. Primary objective is parent stress at 12 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(meets at least one of the following criteria):
- •Infant born ≤ 26+6 weeks of gestational age (GA)
- •Infant born between 27-29+6 weeks GA with ≥ 1 of the following risk factors:
- •i)≥ Grade III intraventricular hemorrhage with post hemorrhagic hydrocephalus ii)Retinopathy of prematurity requiring intraocular bevacizumab/ anti-vascular endothelial growth factor or laser surgery therapy iii)Requires invasive (e.g., intubated) or non-invasive (e.g., CPAP or BiPAP) at ≥ 34 weeks GA and/or supplemental oxygen at ≥ 37 weeks gestational age iv)Requires surgery for management of necrotizing enterocolitis (NEC)- stage 3
- •Infant with ≥ 2 major congenital anomalies as defined by EUROCAT(13) (e.g., congenital heart disease, spina bifida, cleft palate, etc. Not including minor congenital anomalies, e.g., dysmorphic facies), and length of stay in recruiting institution ≥ 14 days.
- •Infant with hypoxic ischemic encephalopathy (HIE) requiring therapeutic hypothermia and in the recruiting institution for ≥ 14 days.
排除标准
- •Families that do not speak English or French
- •Parent will not be involved with child's care over the entirety of the study period (2 years) (e.g., adoption).
- •Infant will be followed by an out-of-province neonatal follow-up program or lives a significant distance from the neonatal follow up program and therefore not routinely followed by the team.
- •Infant that has previously been discharged home from the NICU/hospital.
- •Decision/high likelihood of decision for act of withdrawal of care by clinical teams/families
研究组 & 干预措施
CCENT Intervention group
Participants will be assigned a dedicated key worker that will support families through the child's first year, in addition to standard medical care, which involves a primary care provider and/or neonatal follow-up at routine times.
干预措施: CCENT Intervention (Other)
Control group
Participants will receive the standard medical care at their institution, which involves a primary care provider and/or neonatal follow-up at routine times.
结局指标
主要结局
Change in Parental Stress
时间窗: 12 months
This outcome will be assessed using the Parenting Stress Index 4th Edition (PSI-4) Short Form questionnaire.
次要结局
- Parental Empowerment(12 months)
- Child Development(18 months)
- Parental Quality of Life (QoL)(12 months)
- Parent and Child Interaction(12 months)
- Healthcare Service Delivery(12 months)
- Child Social and Emotional Development(12 months)
- Maternal Depression(12 months)
- Maternal Anxiety(12 months)
- Resource Utilization(12 months)
- Psychology Inflexibility(18 months)
- Parental perception of transition experience(6 weeks post discharge)
- Parental Quality of Life (QoL)(4 months)
- Maternal Depression(6 weeks)
- Maternal Depression(4 months)
- Maternal Anxiety(4 months)
- Resource Utilization(4 months)
- Psychology Inflexibility(6 weeks)
- Psychology Inflexibility(4 months)
- Psychology Inflexibility(12 months)
研究者
Julia Orkin
Staff Physician, Medical Director of the Complex Care Program
The Hospital for Sick Children