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NCT05455359PHASE4Recruiting

Gastrointestinal Dysmotility on Aspiration Risk

Boston Children's Hospital

Start Date

2/13/2025

Completion Date

5/31/2027

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.

Eligibility Criteria

Age Range: 5 years to 21 years

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. -

Interventions

DRUG

Prucalopride

DRUG

Famotidine

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Conditions

Esophageal Motility DisordersGastric Motor DysfunctionAspiration PneumoniaGastro Esophageal Reflux

Locations

Boston Children's Hospital

Boston, Massachusetts 02115

United States