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.
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 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
Crossover
Prucalopride
DrugPrucalopride 0.04 mg/kg/day
Famotidine
DrugFamotidine 0.4 mg/kg/day
Pediatric Cough Quality of Life Questionnaire
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
Gastric emptying outcomes
Comparison of within-patient differences in gastric residuals by nuclear scintigraphy
Total Peds-GI QL score
Comparison of the mean difference in total Peds-GI QL scores (range: 0-100, lower=worse symptoms) between famotidine and prucalopride periods
Aspiration symptoms
Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment
Microbiome
Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period
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