Aspiration Pneumonia, Esophageal Motility Disorders, Gastric Motor Dysfunction, Gastro Esophageal Reflux
Conditions
Brief summary
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
DRUGFamotidine
Famotidine 0.4 mg/kg/day
DRUGPrucalopride
Prucalopride 0.04 mg/kg/day
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. are 5-21 years of age; 2. receive \>90% of their calories by enteral tube (i.e., patients take no food or drink by mouth); 3. 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; 4. 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; 5. 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
1. have progressive neurologic impairment; 2. have a history of prior intact Nissen fundoplication; 3. are currently taking oral or inhaled antibiotics, including prophylactic antibiotics; 4. are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or 5. are fed by gastrojejunostomy rather than by gastrostomy. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Cough Quality of Life Questionnaire | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying outcomes | 4 weeks | Comparison of within-patient differences in gastric residuals by nuclear scintigraphy |
| Total Peds-GI QL score | 8 weeks | Comparison of the mean difference in total Peds-GI QL scores (range: 0-100, lower=worse symptoms) between famotidine and prucalopride periods |
| Aspiration symptoms | 4 weeks | Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment |
| Microbiome | 8 weeks | Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period |
| Pneumonias | 10 weeks | Comparisons in the number of aspiration pneumonias between each treatment period |
| Esophageal reflux events | 4 weeks | Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy |
Countries
United States
Contacts
CONTACTRachel Rosen, MD
Outcome results
None listed