Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dysphagia Aspiration Quality of Life |
Procedure: Injection laryngoplasty |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft |
- Change in quality of life [ Time Frame: 3-4 months after procedure ] [ Designated as safety issue: No ]Measured via previously validated pediatric quality of life survey for dysphagia
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
-
Procedure: Injection laryngoplasty
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lourdes Quintanilla-Dieck, MD | (503) 494-8311 ext 12636 | quintani@ohsu.edu |
| Contact: Carol MacArthur, MD | (503) 494-5350 | macarthc@ohsu.edu |
| United States, Oregon | |
| Oregon Health & Science University - Doernbecher Children's Hospital | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Lourdes Quintanilla-Dieck, MD 503-494-8311 ext 12636 quintani@ohsu.edu | |
| Contact: Carol MacArthur, MD (503)494-5350 macarthc@ohsu.edu | |
| Principal Investigator: Carol MacArthur, MD | |
| Sub-Investigator: Maria de Lourdes Quintanilla-Dieck, MD | |
| Sub-Investigator: Henry Milczuk, MD | |
| Principal Investigator: | Carol MacArthur, MD | Oregon Health and Science University |
More Information
Publications:
| Responsible Party: | Maria de Lourdes Quintanilla-Dieck, MD, Resident Physician, Department of Otolaryngology Head & Neck Surgery, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT01507207 History of Changes |
| Other Study ID Numbers: | IRB 7850 |
| Study First Received: | January 4, 2012 |
| Last Updated: | January 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Dysphagia aspiration pediatric injection laryngoplasty |
Additional relevant MeSH terms:
|
Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013