Nutritional Care After Hospital Discharge (NutriCAD): A Stepped Wedged Multicentre Randomized Controlled Trial in Paediatrics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 6
- 主要终点
- Head circumference
研究概览
简要总结
The goal of this stepped wedge cluster randomized trial is to compare nutritional care after discharge to an intervention in children term born - 18 years old discharged with newly initiated nutritional care.
The main question it aims to answer is:
To investigate whether a tailored nutritional care follow-up program in children who are being discharged from the hospital with nutritional support improves nutritional intake and status as well as feeding behavior and quality of life (QoL) in children and their parents. Furthermore, the effect on parental stress, anxiety, depression, and post-traumatic stress (PTSD) as well as QoL will be assessed with and without a tailored nutritional care follow-up program
详细描述
All subjects, both in the usual care and intervention group, will be treated with the standard nutritional protocols of these individual hospitals during hospitalization. After hospital discharge, the treatments of the intervention and the control group will entail the procedures as described below.
Intervention group The intervention consists of a tailored nutritional follow-up plan, including a parent empowerment program, made by a multidisciplinary support team (primarily responsible clinician, dietician, psychologist and, if indicated, a speech therapist). At discharge and follow-up at 6, 12 and 18 weeks after discharge, food diaries (including growth) and questionnaires* relating to feeding behaviour and parental stress are filled out by parents/caregivers.
One week before the planned outpatient visit of the patient and their parents, questionnaires will be sent with preferred software available in ErasmusMC ICT infrastructure through e-mail. The findings gathered from these nutritional data and questionnaires will be visualized on a dashboard (visible to parents and the caregivers) to discuss and help resolve the most relevant problems with the parents during the follow-up moments. During the outpatient visit, the growth and body composition of the child will also be assessed.
The nutritional support team will discuss the outcomes of the questionnaires and make tailored advice based on the problems parents have reported. The dietician will discuss this tailored advice with the children and/or parents based on the growth, the nutritional intake of the child, and the problems parents have reported regarding the feeding behaviour of the child and their parental distress. Subsequently, the dietician will provide recommendations and psychoeducation to parents and/or patients in order to improve the nutritional status.
At 6 months after discharge follow/up measurements such as, growth, duration and frequency of nutritional support, food diary, feeding behaviour of the child, QoL of the child, parental stress and QoL will be gathered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children term born neonates till 18 years old
- •Admitted with newly initiated nutritional support(oral and/or enteral nutritional support) during hospitalization
- •Nutritional Support continues at home after discharge.
排除标准
- •Children with existing nutritional support upon admission
- •Children in need of parenteral nutrition at discharge
- •Children with DSM-5 diagnosed feeding disorders such as anorexia
- •Absence of written informed consent
研究组 & 干预措施
Control group/usual care group
The usual care as given at that moment in that hospital. The group to compare the intervention with.
Intervention group
The intervention consists of a tailored nutritional follow-up plan, including a parent empowerment program, made by a multidisciplinary support team (primarily responsible clinician, dietician, psychologist and, if indicated, a speech therapist). At discharge and follow-up at 6, 12 and 18 weeks after discharge, food diaries (including growth) and questionnaires* relating to feeding behaviour and parental stress are filled out by parents/caregivers.
干预措施: A structured follow-up with a tailored made nutritional plan and a parent empowerment program (Other)
结局指标
主要结局
Head circumference
时间窗: From enrollment until 6 months after discharge
in centimeters and z-scores
Mid-upper arm circumference
时间窗: From enrollment until 6 months after discharge
in centimeters and z-scores
Length in children <2 years of age
时间窗: From enrollment until 6 months after discharge
in centimeters and z-scores
Weight
时间窗: From enrollment until 6 months after discharge
in kilograms, cm and z-scores
Height
时间窗: From enrollment until 6 months after discharge
in meters and z-scores
次要结局
- Feeding behaviour of the child(From enrollment until 6 months after discharge)
- Nutritional requirements and intake(From enrollment until 6 months after discharge)
- Parental stress(From enrollment until 6 months after discharge)
- Cost-effectiveness of tailored nutritional care(From enrollment until 6 months after discharge)
- Barriers and facilitators of implementation of the multidisciplinary support team(After the intervention)
- Dependency on nasogastric tube feeding(From enrollment until 6 months after discharge)
- Duration and frequency of nutritional support(From enrollment until 6 months after discharge)
- Body composition(From enrollment until 6 months after discharge)
- Quality of Life of children and parents(From enrollment until 6 months after discharge)
研究者
S.C.A.T Verbruggen
Principal Investigator
Erasmus Medical Center