A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 16
- 主要终点
- Health and feeding related quality of life
研究概览
简要总结
The primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. Secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.
详细描述
Bolus enteral tube feeding (termed 'bolus feeding') is an increasingly common method of providing nutritional support to home enterally tube fed (HETF) patients, particularly those who are more active and/or require greater flexibility in their feeding regimen. However, current methods of bolus feeding are complex to administer, messy, may be unhygienic, and require and lead to a significant amount of plastic waste. Therefore, there is a clear need for a simpler and optimised way to provide bolus feeds. The aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life, ease of use, liking, compliance, gastrointestinal tolerance, nutritional intake, anthropometry and safety. This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥16 years of age
- •Using or requiring an enteral tube feed as part of nutritional management plan
- •Using or about to use bolus tube feeding methods at least once daily
- •Expected to receive at least 400 kcal/day from the intervention feed
- •Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign.
排除标准
- •Parenteral nutrition contributing more than 70% of total energy requirements
- •Patients with major hepatic dysfunction (i.e., decompensated liver disease)
- •Patients with major renal dysfunction [i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)]
- •Patients receiving inpatient care
- •Participation in other clinical intervention studies within 2 weeks of this study
- •Adults lacking mental capacity to consent
- •Allergy to any study product ingredients
- •Investigator concern regarding ability or willingness of patient to comply with the study requirements.
结局指标
主要结局
Health and feeding related quality of life
时间窗: Baseline to end of intervention (Day 35)
At baseline, and at the mid-point and end of the intervention period, health and feeding related quality of life will be assessed by the FACT-EQ questionnaire.
次要结局
- Ease of administration(Baseline to end of intervention (Day 35))
- Gastrointestinal tolerance(Baseline to end of intervention (Day 35))
- Liking of feeding method(Baseline to end of intervention (Day 35))
- Nutrient intake(Baseline to end of intervention (Day 35))
- Adverse Events(Baseline to end of intervention (Day 35))
- Compliance(Baseline to end of intervention (Day 35))
- Body weight (kg)(Baseline to end of intervention (Day 35))