Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Maria de Lourdes Quintanilla-Dieck, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01507207
First received: January 4, 2012
Last updated: January 5, 2012
Last verified: January 2012
  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

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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)
Intervention Details:
    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.
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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507207

Contacts
Contact: Lourdes Quintanilla-Dieck, MD (503) 494-8311 ext 12636 quintani@ohsu.edu
Contact: Carol MacArthur, MD (503) 494-5350 macarthc@ohsu.edu

Locations
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         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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 July 24, 2014