Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Location status: Recruiting
NCT Number: NCT05455359
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.
Interested in participating?
Request Info5 year–21 year
All sexes
Interventional
Phase 4
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Exclusion criteria
Prucalopride 0.04 mg/kg/day
Famotidine 0.4 mg/kg/day
Time frame: 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
Time frame: 4 weeks
Comparison of within-patient differences in gastric residuals by nuclear scintigraphy
Time frame: 8 weeks
Comparison of the mean difference in total Peds-GI QL scores (range: 0-100, lower=worse symptoms) between famotidine and prucalopride periods
Time frame: 4 weeks
Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment
Time frame: 8 weeks
Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period
Time frame: 10 weeks
Comparisons in the number of aspiration pneumonias between each treatment period
Time frame: 4 weeks
Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy
Contact information is provided by the study sponsor or research team.
Boston Children's Hospital
Other
The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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