Gastrointestinal Dysmotility on Aspiration Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prucalopride, Famotidine.
- Who it may be relevant to
- Registry conditions: Esophageal Motility Disorders, Gastric Motor Dysfunction, Aspiration Pneumonia, Gastro Esophageal Reflux. Basic parameters: 5 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms
Overview
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.
Interventions
- Drug Prucalopride
Prucalopride 0.04 mg/kg/day - Drug Famotidine
Famotidine 0.4 mg/kg/day
Primary outcome measures
- Pediatric Cough Quality of Life Questionnaire [Time frame: 4 weeks]
Secondary outcome measures (6)
- Gastric emptying outcomes [Time frame: 4 weeks]
- Total Peds-GI QL score [Time frame: 8 weeks]
- Aspiration symptoms [Time frame: 4 weeks]
- Microbiome [Time frame: 8 weeks]
- Pneumonias [Time frame: 10 weeks]
- Esophageal reflux events [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
- 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.
\-
Exclusion criteria
- 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. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT05455359 · IRB-P00038381