Esophagus and stomach movement problems and aspiration risk in children with neurologic impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 10-week, randomized crossover Phase 4 trial at Boston Children's Hospital comparing prucalopride (a prokinetic) to famotidine (an acid suppressant) for treating aspiration-associated symptoms. Participants are children and young adults 5–21 years old who receive >90% of calories by enteral tube, have documented aspiration on video fluoroscopic swallow study, static neurologic impairment, and frequent respiratory symptoms. Each participant receives both study medications in sequence with symptom monitoring to compare effects on coughing, choking, need for oral suctioning, and other aspiration-related outcomes. The trial measures short-term symptomatic response rather than long-term disease modification.

Why it matters

Who can join: the full rules

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. -

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Rachel Rosen, MD
• Email: rachel.rosen@childrens.harvard.edu
• Phone: 617-355-0897

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.