RecruitingPhase 4NCT05455359

Gastrointestinal Dysmotility on Aspiration Risk

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

Sponsor

Boston Children's Hospital

Enrollment

120 participants

Start Date

Feb 13, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Motility Disorders Gastric Motor Dysfunction

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

Min Age: 5 YearsMax Age: 21 Years

Inclusion Criteria6

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.
\-

Exclusion Criteria5

have progressive neurologic impairment;
have a history of prior intact Nissen fundoplication;
are currently taking oral or inhaled antibiotics, including prophylactic antibiotics;
are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or
are fed by gastrojejunostomy rather than by gastrostomy. -

Interested in this trial?

Get notified about updates and connect with the research team.