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Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 4, 2012
First Posted Date  ICMJE January 10, 2012
Last Update Posted Date September 20, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
Change in quality of life [ Time Frame: 3-4 months after procedure ]
Measured via previously validated pediatric quality of life survey for dysphagia
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01507207 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft
Official Title  ICMJE Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dysphagia
  • Aspiration
  • Quality of Life
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 15, 2015
Actual Primary Completion Date May 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01507207
Other Study ID Numbers  ICMJE IRB 7850
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria de Lourdes Quintanilla-Dieck, MD, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carol MacArthur, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP