Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

NCT01507207 | Completed Phase 4

• 1 other identifier: IRB 7850
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Aspiration; Quality of Life

Keywords

Dysphagia; aspiration; pediatric; injection laryngoplasty

Outcome Measures

Primary Outcomes (1)

• Change in quality of life

  Measured via previously validated pediatric quality of life survey for dysphagia

  3-4 months after procedure

Interventions

Injection laryngoplasty PROCEDURE

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• inability or parent refusal to undergo procedure under general anesthesia in the operating room

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University - Doernbecher Children's Hospital

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• 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.

  PMID: 21493369 BACKGROUND

• 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.

  PMID: 22183897 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Carol MacArthur, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Otolaryngology Head & Neck Surgery

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 10, 2012
• Study Start: January 1, 2012
• Primary Completion: May 15, 2015
• Study Completion: May 15, 2015
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

US (1)