Weaning is Winning? (WeWin Study): Are Parenteral Nutrition (PN) Graduates Growing up Healthy?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).
详细描述
Children with IF depend on PN. This is associated with frequent and various complications such as metabolic bone disease, micronutrient deficiencies and abnormal body composition. Due to advancements in care, many patients with IF are able to wean off PN; they are so called PN graduates. It is currently not well known how often complications do occur after weaning off PN, and which patients are at highest risk of developing these complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parenteral Nutrition graduates for at least 1 year, with a history of intestinal failure.
- •Age <18 years at time of inclusion.
排除标准
- •No consent provided.
研究组 & 干预措施
Erasmus
Patients recruited from the Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands
干预措施: Weaning off Parenteral Nutrition (Other)
SickKids
Patients recruited from the Hospital for Sick Children (SickKids), Toronto, Canada
干预措施: Weaning off Parenteral Nutrition (Other)
结局指标
主要结局
Complications
时间窗: From 1 year after weaning off PN to 18 years of age
Assess the frequency of nutritional complications including poor growth, micronutrient deficiencies, poor bone health, abnormal body composition, and delayed pubertal development in PN graduates.
次要结局
未报告次要终点
研究者
Jessie Hulst
Staff Physician
The Hospital for Sick Children