- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01507207
Pediatric Dysphagia Outcomes After Injection Laryngoplasty for Type I Laryngeal Cleft
September 18, 2017 updated by: Maria de Lourdes Quintanilla-Dieck, MD, Oregon Health and Science University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University - Doernbecher Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life
Time Frame: 3-4 months after procedure
|
Measured via previously validated pediatric quality of life survey for dysphagia
|
3-4 months after procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carol MacArthur, MD, Oregon Health and Science University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ACTUAL)
May 15, 2015
Study Completion (ACTUAL)
May 15, 2015
Study Registration Dates
First Submitted
January 4, 2012
First Submitted That Met QC Criteria
January 5, 2012
First Posted (ESTIMATE)
January 10, 2012
Study Record Updates
Last Update Posted (ACTUAL)
September 20, 2017
Last Update Submitted That Met QC Criteria
September 18, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 7850
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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