RecruitingPhase 4

Gastrointestinal Dysmotility on Aspiration Risk

United States120 participantsStarted 2025-02-13

Plain-language 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.

Who can participate

Age range5 Years – 21 Years

SexALL

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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.

Exclusion criteria

✕. 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. -

What they're measuring

Pediatric Cough Quality of Life Questionnaire

Timeframe: 4 weeks

Trial details

NCT IDNCT05455359

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-31

Contact for this trial

Rachel Rosen, MD

617-355-0897 rachel.rosen@childrens.harvard.edu

View on ClinicalTrials.gov More Esophageal Motility Disorders trials