Gastrointestinal Dysmotility on Aspiration Risk

• Status: Not yet recruiting
• Trial end date: 2027-07-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital
• Treatments: Famotidine; Prucalopride

Criteria

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.

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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. -