Clinical trial NCT01507207: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysphagia
Aspiration
Quality of Life
Keywords: Dysphagia
aspiration
pediatric
injection laryngoplasty
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2012-01-10
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in quality of life
timeFrame: 3-4 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University - Doernbecher Children's Hospital
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Carol MacArthur, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.