Gastrointestinal Dysmotility on Aspiration Risk
Recruiting
Phase 4
Interventional Study
Esophageal Motility Disorders
Gastric Motor Dysfunction
Aspiration Pneumonia
Gastro Esophageal Reflux
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 5 – 21
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Boston Children's Hospital · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. are 5-21 years of age;
2. receive \>90% of their calories by enteral tube (i.e., patients take no food or drink by mouth);
3. are determined to be at high risk for aspiration pneumonia based on evidence of impaired airway protective mechanisms, documented by aspiration on vid…
Contacts