Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

Quality of Life Clinical Trial

Official title:

Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507207
• Other study ID #: IRB 7850
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2012
• Last updated: September 18, 2017
• Start date: January 2012
• Est. completion date: May 15, 2015

Study information

• Verified date: September 2017
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 15, 2015
• Est. primary completion date: May 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Aspiration
• Deglutition Disorders
• Dysphagia
• Quality of Life

Intervention

Procedure:
• Injection laryngoplasty
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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University - Doernbecher Children's Hospital	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life	Measured via previously validated pediatric quality of life survey for dysphagia	3-4 months after procedure