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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Prucalopride 0.04 mg/kg/day
Famotidine 0.4 mg/kg/day
Boston Children's Hospital
Boston, Massachusetts, United States
RECRUITINGPediatric 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
Time frame: 4 weeks
Gastric emptying outcomes
Comparison of within-patient differences in gastric residuals by nuclear scintigraphy
Time frame: 4 weeks
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
Time frame: 8 weeks
Aspiration symptoms
Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment
Time frame: 4 weeks
Microbiome
Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period
Time frame: 8 weeks
Pneumonias
Comparisons in the number of aspiration pneumonias between each treatment period
Time frame: 10 weeks
Esophageal reflux events
Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy
Time frame: 4 weeks
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