The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pediatric Cough Quality of Life Questionnaire
研究概览
简要总结
The hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. The investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspiration-associated symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are 5-21 years of age;
- •receive >90% of their calories by enteral tube (i.e., patients take no food or drink by mouth);
- •are determined to be at high risk for aspiration pneumonia based on evidence of impaired airway protective mechanisms, documented by aspiration on video fluoroscopic swallow study;
- •have static neurologic impairment, defined as functional and/or intellectual impairment that results from a chronic neurologic or related diagnosis (e.g., cerebral palsy) with no prospect of progression for at least one year;
- •have chronic respiratory symptoms, defined as coughing, choking, or need for oral suctioning a minimum of three times per week during the prior four weeks.
排除标准
- •have progressive neurologic impairment;
- •have a history of prior intact Nissen fundoplication;
- •are currently taking oral or inhaled antibiotics, including prophylactic antibiotics;
- •are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or
- •are fed by gastrojejunostomy rather than by gastrostomy. -
研究组 & 干预措施
Arm 1
Patients will be undergo 1 week observation period followed by 4 weeks of prucalopride followed by 1 weeks of a wash out followed by 4 weeks of famotidine
干预措施: Prucalopride (Drug)
Arm 1
Patients will be undergo 1 week observation period followed by 4 weeks of prucalopride followed by 1 weeks of a wash out followed by 4 weeks of famotidine
干预措施: Famotidine (Drug)
Arm 2
Patients will be undergo 1 week observation period followed by 4 weeks of famotidine followed by 1 weeks of a wash out followed by 4 weeks of prucalopride
干预措施: Prucalopride (Drug)
Arm 2
Patients will be undergo 1 week observation period followed by 4 weeks of famotidine followed by 1 weeks of a wash out followed by 4 weeks of prucalopride
干预措施: Famotidine (Drug)
结局指标
主要结局
Pediatric Cough Quality of Life Questionnaire
时间窗: 4 weeks
Comparison of the mean difference in the Pediatric Cough Quality of Life Questionnaire (range: 7 to 189, lower scores=more symptom impairment) between baseline and 4 week scores between Arm 1 and Arm 2
次要结局
- Gastric emptying outcomes(4 weeks)
- Aspiration symptoms(4 weeks)
- Microbiome(8 weeks)
- Pneumonias(10 weeks)
- Total Peds-GI QL score(8 weeks)
- Esophageal reflux events(4 weeks)
研究者
Rachel Rosen
Associate Professor of Pediatrics
Boston Children's Hospital