Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Reflux episodes
研究概览
简要总结
Blenderized diets consist of a wide range of table foods such as fruits, vegetables, meat and legumes, pureed in a blender and administered via gastrostomy tube. In a recent study, the investigators reported that children receiving blenderized feeds via gastrostomy had fewer total admissions and respiratory admissions, total emergency room visits, and improved gastrointestinal symptom scores compared to those fed formula. The goal of this project is to understand how these diets affect gastroesophageal reflux burden.
详细描述
The investigators hypothesize that rates of gastroesophageal reflux will be lower in blenderized diets compared to formula. The investigators will determine if reflux burden as measured by multichannel intraluminal impedance/esophageal pH monitoring performed for clinical purposes differs between low viscosity conventional formula, medium viscosity commercial blenderized diet, and high viscosity commercial blenderized diet in 45 children receiving conventional formula via gastrostomy. All participants will receive each of the three test diets in random order in a 3-way crossover design. Results of gastric emptying scans will be recorded if done for clinical purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-21 years
- •Able to tolerate bolus gastric feeds over 30 minutes
- •Use of conventional enteral formula
- •Undergoing impedance study for clinical purposes
排除标准
- •History of allergy or intolerance to any component of the test diets
- •History of Nissen fundoplication (participants with suspected or documented unwrapped fundoplication will be eligible for participation)
- •Current use of non-invasive pressure support (continuous or bi-level positive airway pressure)
结局指标
主要结局
Reflux episodes
时间窗: 4 hours (following feed)
Number of total reflux episodes (acid and non-acid) by impedance
次要结局
- Full column reflux episodes(4 hours (following feed))
- Percent of time esophageal pH < 4(4 hours after feed)
- Average height of refluxate(4 hours after feed)
- Number of symptoms(4 hours after feed)
研究者
Bridget Hron
Staff Physician
Boston Children's Hospital