Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

Phase 4

Completed

• Conditions: Dysphagia; Quality of Life; Aspiration

• Registration Number: NCT01507207
• Lead Sponsor: Oregon Health and Science University

Brief Summary

Type I laryngeal cleft evaluation and treatment in the pediatric population is an emerging science. The largest published series of pediatric patients with type I laryngeal clefts shows conflicting evidence in terms of outcomes, resolution of dysphagia and method of treatment. A comparison of quality of life outcomes before and after injection laryngoplasty has not been carried out. The investigators hypothesize that injection laryngoplasty significantly improves symptoms and quality of life related to dysphagia in a pediatric population with laryngeal clefts.

Detailed Description

Dysphagia with aspiration is a common disorder in the pediatric population. Aspiration with feeds is diagnosed on modified barium swallow studies and patients are referred to the pediatric otolaryngologist to assess the airway for a possible laryngeal cleft. Type I laryngeal cleft can lead to dysphagia and aspiration in young children. However, diagnosis of type I laryngeal cleft can be difficult and subjective at microlaryngoscopy in the operating room. Type I laryngeal cleft evaluation and treatment in the pediatric population is an emerging science. The largest published series of pediatric patients with type I laryngeal clefts shows conflicting evidence in terms of outcomes, resolution of dysphagia and method of treatment. It is generally recommended to do an injection laryngoplasty at the time of airway evaluation as a diagnostic and therapeutic measure. Improvement in symptoms supports the diagnosis and can serve as either definitive treatment with repeated injections or as a preemptive treatment in preparation for surgical repair. A comparison of quality of life outcomes before and after injection laryngoplasty has not been carried out. Thus, the aim of this study is to determine if injection laryngoplasty improves symptoms and quality of life related to dysphagia in a pediatric population with laryngeal clefts.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-10
• Primary Completion: 2015-05-15
• Study Completion: 2015-05-15
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• chief complaint of dysphagia and/or aspiration detected on a clinical swallow assessment and/or modified barium swallow study
• able to withstand general anesthesia and direct microlaryngoscopy in the operating room

Exclusion Criteria

• inability or parent refusal to undergo procedure under general anesthesia in the operating room

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in quality of life	3-4 months after procedure	Measured via previously validated pediatric quality of life survey for dysphagia

Trial Locations

Locations (1)

Oregon Health & Science University - Doernbecher Children's Hospital; 🇺🇸 Portland, Oregon, United States