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Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

Primary Purpose

Dysphagia, Aspiration, Quality of Life

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Injection laryngoplasty
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia, aspiration, pediatric, injection laryngoplasty

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University - Doernbecher Children's Hospital

Outcomes

Primary Outcome Measures

Change in quality of life
Measured via previously validated pediatric quality of life survey for dysphagia

Secondary Outcome Measures

Full Information

First Posted
January 4, 2012
Last Updated
September 18, 2017
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01507207
Brief Title
Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft
Official Title
Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 15, 2015 (Actual)
Study Completion Date
May 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Aspiration, Quality of Life
Keywords
Dysphagia, aspiration, pediatric, injection laryngoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Injection laryngoplasty
Intervention Description
Patients will undergo a direct microlaryngoscopy in the operating room for diagnostic purposes. In patients in whom laryngeal cleft is diagnosed, injection laryngoplasty will be carried out using sodium carboxymethylcellulose aqueous gel (commercial name Radiesse) injection material.
Primary Outcome Measure Information:
Title
Change in quality of life
Description
Measured via previously validated pediatric quality of life survey for dysphagia
Time Frame
3-4 months after procedure

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol MacArthur, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University - Doernbecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21493369
Citation
Cohen MS, Zhuang L, Simons JP, Chi DH, Maguire RC, Mehta DK. Injection laryngoplasty for type 1 laryngeal cleft in children. Otolaryngol Head Neck Surg. 2011 May;144(5):789-93. doi: 10.1177/0194599810395082.
Results Reference
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PubMed Identifier
22183897
Citation
Clayburgh D, Milczuk H, Gorsek S, Sinden N, Bowman K, MacArthur C. Efficacy of tonsillectomy for pediatric patients with Dysphagia and tonsillar hypertrophy. Arch Otolaryngol Head Neck Surg. 2011 Dec;137(12):1197-202. doi: 10.1001/archoto.2011.196.
Results Reference
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Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

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