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Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

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ClinicalTrials.gov Identifier: NCT01507207
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Maria de Lourdes Quintanilla-Dieck, MD, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Dysphagia Aspiration Quality of Life Procedure: Injection laryngoplasty Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft
Study Start Date : January 2012
Actual Primary Completion Date : May 15, 2015
Actual Study Completion Date : May 15, 2015

Resource links provided by the National Library of Medicine



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.


Primary Outcome Measures :
  1. Change in quality of life [ Time Frame: 3-4 months after procedure ]
    Measured via previously validated pediatric quality of life survey for dysphagia



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507207


Locations
United States, Oregon
Oregon Health & Science University - Doernbecher Children's Hospital
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Carol MacArthur, MD Oregon Health and Science University

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
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Maria de Lourdes Quintanilla-Dieck, MD, 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