A prospective, single arm, post market clinical follow-up of Infant Feeding Tube (Feedy) to explore safety and performance in paediatric subjects in Indian population.
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Primary End Point of the study are as
研究概览
简要总结
This is a prospective, post marketing clinical follow-up of Infant Feeding Tube (Feedy) to explore safety and performance in paediatrics that requires enteral nutrition feeding, introduction of fluids etc. Investigators and their team will be responsible for recruitment and ethical conduct of the follow-up. As per inclusion & exclusion criteria, subjects will be included in this follow-up. An Informed Assent Form will be obtained from all subjects and parents/legal guardians.
All data will be collected in the follow-up specific Case Report Form.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Paediatrics male and female who are expected to require enteral nutrition feeding introduction of fluids etc.
- •in paediatrics whose parents legal guardians are willing to provide written informed assent form will be eligible for inclusion in the follow-up.
- •2 Subjects parent LAR Legally Acceptable Representative can provide Informed Assent Form Child.
- •3 Parents or legal guardians must be able to complete all relevant follow-up procedures during follow-up participation.
排除标准
- •1 Subject who present with medical emergency where treatment is more priority than the informed assent process.
- •2 Subjects paediatrics with severe malabsorption intestinal obstruction.
- •3 History of any reaction or hypersensitivity likely to be exacerbated by any components of the Infant Feeding Tube or Feedy.
- •4 Subject with congenital defect or serious chronic illness.
- •5 Other conditions which in the opinion of investigators make the subject unsuitable for enrolment or could interfere with his participation in and completion of the clinical investigation plan.
- •6 Participation in another research study involving an active investigation within 30 days prior to consent.
结局指标
主要结局
The Primary End Point of the study are as
时间窗: Device maximum use duration is not more than 7 days.
1 Intubation of nasal or oral passage with Infant Feeding Tube clinically intended for enteral feeding purpose.
时间窗: Device maximum use duration is not more than 7 days.
2 Facilitating clinical use for enteral feeding.
时间窗: Device maximum use duration is not more than 7 days.
3 Facilitating clinical use for medical conditions requiring aspiration of gastric content.
时间窗: Device maximum use duration is not more than 7 days.
4 Improving the quality of life of the subject by achieving the intended purpose.
时间窗: Device maximum use duration is not more than 7 days.
次要结局
- The Secondary End Point of the study are as(1 Durability sustainability & device fixation with standard combination devices required the clinical use.)
研究者
Dr Sanjay Kala
GSVM Medical College