Use of Intrapyloric Botulinum Injections in Children

NCT04250844 | Unknown DMC

• 1 other identifier: P00033019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vomiting; Feeding Disorders; Gastroparesis

Keywords

Botulinum Toxin

Outcome Measures

Primary Outcomes (1)

• Degree of improvement in quality of life

  Quality of life will be measured with the Pediatric Quality of Life Inventory (PedsQL). This is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Each item is answered using a 3-point scale: 0 (Not at all), 2 (Sometimes), 4 (A lot). Scores range 0 to 100, with lower scores indicating worse quality of life. The outcome will be assessed by calculating the change in score from baseline to 4 weeks.

  4 weeks

Secondary Outcomes (1)

• Degree of symptomatic improvement

  4 weeks

Study Arms (2)

Botulinum

We will follow for symptom improvement over time patients with nausea, vomiting, feeding intolerance, or other signs of gastric dysfunction who were determined by their gastroenterologist to require upper endoscopy with intrapyloric botulinum injections and if clinically applicable endoscopic functional luminal imaging probe (EndoFLIP). The dosage will be determined by the patient's physician.

Control

We will follow for symptom improvement over time patients with nausea, vomiting, feeding intolerance, or other signs of gastric dysfunction who were determined by their gastroenterologist to require upper endoscopy without intrapyloric botulinum injections.

Eligibility Criteria

• Age: 30 Days - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients from our tertiary care center who are undergoing upper endoscopy with or without intrapyloric botulinum injections.

You may qualify if:

• Patients with chronic nausea, vomiting, or feeding intolerance undergoing upper endoscopy with or without intrapyloric botulinum injections.
• Age between 30 days and 18 years.

You may not qualify if:

• Significant uncontrolled inflammation on upper or lower endoscopy
• Known inflammatory bowel disease
• Uncontrolled thyroid disease
• Current opioid use

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Vomiting; Feeding and Eating Disorders; Gastroparesis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations

Study Officials

• Rachel Rosen, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanna Hirsch, MD

CONTACT

617-355-6058; suzanna.hirsch@childrens.harvard.edu

Rachel Rosen, MD, MPH

CONTACT

rachel.rosen@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 31, 2020
• Study Start: March 10, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)