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Dysphagia | Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

Dysphagia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dysphagia

Aspiration

Quality of Life

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Injection laryngoplastyPatients 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Completed

Start Date: January 2012

Completed Date: May 15, 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change in quality of life

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Carol MacArthur, MD

Lead Sponsor: Oregon Health and Science University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01507207

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.

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