Evaluation of the Acceptability (including Gastrointestinal Tolerance, Compliance and Palatability) of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children Over 12 Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Gastrointestinal tolerance
研究概览
简要总结
This is an acceptability study (including gastrointestinal tolerance, compliance and palatability) of a high energy peptide based paediatric oral nutritional supplement for children over 12 months of age.
The acceptability data from a minimum of 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).
详细描述
Fifteen (15) participants, aged 12 months and over, requiring a high energy peptide based oral nutritional supplement drink for the dietary management.
The ACBS requirement for evaluable data on 15 participants has informed the trial's recruitment target; however, we may need to exceed this target if any patients give their consent to join the study but then decide not to participate in the study. Participants who join the study and begin using the product would count towards the recruitment total and their data would be included in a submission to the ACBS whether they complete the 7-day study period or not.
Each potential participant must meet all of the inclusion criteria and not meet any of the exclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I. Children aged 1 year and over who require 1-3 bottles of an oral nutritional peptide based supplement drink II. Children who require an oral nutritional supplement or who are already established on a nutritional supplement drink III. Children who require a nutritional supplement drink as bolus feeding via a feeding tube.
- •IV. Children being able to communicate views of acceptability V. Willingly given, written, informed consent from patient or parent/guardian. VI. Willingly given, written assent (if appropriate).
排除标准
- •I. Inability to comply with the study protocol, in the opinion of the investigator.
- •II. Contraindications to any feed ingredients (see nutritional table and ingredients list) III. Require a milk free diet IV. Children under the age of 12 months V. Emergencies
结局指标
主要结局
Gastrointestinal tolerance
时间窗: Day 7 from baseline
Daily record via participant diary: 1. Gastrointestinal tolerance: * Diarrhoea and / or constipation * Bloating and / or distension * Nausea and / or vomiting * Burping / flatulence / regurgitation * Abdominal discomfort / pain/ back arching/ crying 2. Participant compliance: How many feeds taken and volume prescribed each day 3. Acceptability Questionnaires to children and or parents for the evaluation of the acceptability and ease of use of the milk supplement drink Diarrhoea, constipation, bloating, distension, nausea, vomitting, burping, abdominal pain
Compliance
时间窗: Day 7 from baseline
volume suggested versus consumed
次要结局
- weight in kg(Day 8 from baseline)
- height in meters(Day 8 from baseline)