Mic-Key Versus Mini: A Prospective, Randomized Trial for Family Preference Comparing Low Profile Balloon Gastrostomy Buttons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Parent preference
研究概览
简要总结
The objective of this study is to compare two low profile balloon gastrostomy button enteral feeding devices, both currently used as standard of medical care. The investigators aim to compare family preference and rate of complications between the two devices in a prospective cohort of children. This is the first step in comparing initial and long-term outcomes along with the need for seeking medical advice for gastrostomy site-related complications.
The secondary aim of this study is to follow this population long term (4 years) to document the prevalence of: granulation tissue, infection, skin breakdown, and how long the gastrostomy tube balloon remains functional (does not lose water).
详细描述
This is a single center prospective, randomized study with a crossover design, comparing two low profile balloon gastrostomy buttons (Figure 1), MIC-Key™ and MINI One™ that are routinely used at CMH. Each subject will be randomly assigned to one button type at the time of initial placement. After placement, standard practice is to perform the first gastrostomy change in the clinic at 2 months where the primary caregivers replace the button under supervision. Therefore, the initial device after randomization will remain in place for 2 months. At the first scheduled device change, the other type of button will replace the original gastrostomy button device. This will remain in place for another 2 months. At the routine visit at 4 months the parents will be asked to choose which button they prefer to keep. This will meet the primary outcome endpoint of the study. The investigators will continue to follow as many subjects as possible to 4 years in order to identify any potential differences in secondary end points.
A caregiver satisfaction survey is routinely used in the clinics. Parent responses to this survey will be also be used in the study analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 0-5 years of age requiring 0.8 cm or 1.0 cm gastrostomy feeding devices for enteral nutrition seen in the Surgery, GI or Special Care clinics
- •Gastrostomy placement after IRB approval (enrollment will continue until 170 evaluable subjects have completed the 4 month visit. Expected attrition for the 4 year follow-up is 40%.
- •English-speaking families
排除标准
- •Children with dermatologic conditions influencing gastrostomy site healing and tract epithelialization
- •Children with immunosuppression
- •Children with active malignancy requiring treatment
- •Inability to commit to 4 months follow up
结局指标
主要结局
Parent preference
时间窗: 4 months
Parents will be asked which button they prefer to keep at the 4-month visit.
次要结局
- Enteral Access Assessment Sheet(Up to 4 years after button placement)