Gastrointestinal Dysmotility on Aspiration Risk

Launched by BOSTON CHILDREN'S HOSPITAL · Jul 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how issues with the movement of food and liquids through the esophagus and stomach may increase the risk of aspiration pneumonia in children with certain neurological conditions. Aspiration pneumonia can happen when food or liquid enters the lungs instead of the stomach, which can lead to serious health problems. The researchers will compare two medications, prucalopride and famotidine, over a ten-week period to see which one better helps manage symptoms related to aspiration.

To be eligible for this study, participants need to be between 5 and 21 years old and receive most of their nutrition through a feeding tube, meaning they do not eat or drink by mouth. They must also have a confirmed risk for aspiration pneumonia and a stable neurological condition, like cerebral palsy. During the trial, participants will be monitored closely to see how well the medications work for their symptoms. This research aims to find better treatment options for children facing these challenges, and the trial is not yet recruiting participants.

Gender

ALL

Eligibility 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.
• • -
• 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. -