Gastrointestinal Dysmotility on Aspiration Risk

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age5-21
SponsorBoston Children's Hospital

About this trial

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

Qualifiers

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;

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Prucalopride
  • Famotidine

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators