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

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

This trial will test prucalopride versus famotidine to see which better reduces coughing, choking, and other aspiration-associated symptoms in tube-fed children ages 5–21 with neurologic impairment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 5 Years to 21 Years
• Sex: All
• Sponsor: Boston Children's Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05455359 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children and young adults (5–21 years) who are tube-fed for >90% of calories, have static neurologic impairment, documented aspiration on video fluoroscopic swallow study, and chronic respiratory symptoms occurring at least three times per week.

Not a fit: Patients with progressive neurologic disease, prior intact Nissen fundoplication, current use of antibiotics, or other protocol exclusion criteria would not be eligible and therefore would not benefit from this study's interventions.

Why it matters

Potential benefit: If successful, the trial could identify a medication strategy that reduces coughing, choking, and other aspiration-associated symptoms and potentially lower aspiration-related complications in this high-risk group.

How similar studies have performed: Prior studies of prokinetic or acid-suppressing approaches for aspiration symptoms in children are limited and have shown mixed results, so applying prucalopride versus famotidine in this specific population is relatively novel.

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.

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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 this trial is running

Boston, Massachusetts

• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Rachel Rosen, MD

Conditions Esophageal Motility Disorders; Gastric Motor Dysfunction; Aspiration Pneumonia; Gastro Esophageal Reflux