NCT04250844

Use of Intrapyloric Botulinum Injections in Children

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 30 Days – 18 Years
• Healthy volunteers: —

Summary

This study aims to evaluate the effect of intrapyloric botulinum toxin in children with feeding disorders.

Detailed description

Chronic vomiting and feeding difficulties are common in young children and have a negative physical and psychosocial impact for patients and families. Currently there is no straightforward treatment algorithm for these issues, and management often involves multiple medication trials and procedures. Intrapyloric botulinum toxin injection has been proposed as a treatment for nausea and vomiting in adults, but there is minimal prior research on use in children and no prior research on use in children with feeding disorders. The aims of this study are: (1) to determine the efficacy of intrapyloric botulinum toxin injection for reducing gastrointestinal symptoms in children, (2) to determine the efficacy of intrapyloric botulinum injections for improving feeding outcomes in children, and (3) to define predictors of response to intrapyloric botulinum toxin injection.

Conditions

• Vomiting
• Feeding Disorders
• Gastroparesis

Timeline

• Start date: 2020-03-10
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-01-31
• Last updated: 2020-12-08

Locations

1 site across 1 country: United States