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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients will be undergo 1 week observation period followed by 4 weeks of prucalopride followed by 1 weeks of a wash out followed by 4 weeks of famotidine |
|
| Arm 2 | Experimental | Patients will be undergo 1 week observation period followed by 4 weeks of famotidine followed by 1 weeks of a wash out followed by 4 weeks of prucalopride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prucalopride | Drug | Prucalopride 0.04 mg/kg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying outcomes | Comparison of within-patient differences in gastric residuals by nuclear scintigraphy | 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 |
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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.
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Rosen, MD | Contact | 617-355-0897 | rachel.rosen@childrens.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D011015 | Pneumonia, Aspiration |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C406662 | prucalopride |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Famotidine |
| Drug |
Famotidine 0.4 mg/kg/day |
|
| 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 | 4 weeks |
| Microbiome | Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period | 8 weeks |
| Pneumonias | Comparisons in the number of aspiration pneumonias between each treatment period | 10 weeks |
| Esophageal reflux events | Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy | 4 weeks |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |