The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children



Status:Recruiting
Healthy:No
Age Range:4 - 11
Updated:1/11/2019
Start Date:March 1, 2017
End Date:June 2021
Contact:Ellen M Mandel, MD
Email:ellen.mandel@chp.edu
Phone:412-692-5463

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The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children: A Pilot Study

Voice disorders are the most common communication disorder across the lifespan and vocal fold
nodules are the most frequent pathology affecting voice in children. The goal of the present
study is to determine the safety and feasibility of a short-course of inhaled corticosteroids
in addition to standard voice therapy for treating vocal fold nodules.

Voice disorders are the most common communication disorder across the lifespan, affecting
more than 5 million school-aged children annually in the United States. Vocal fold nodules
are the most frequent pathology affecting voice in children, with 21% of children negatively
influenced at any given point in time, resulting in negative quality of life consequences and
inferior academic performance. The traditional first-line approach to treatment of vocal fold
nodules is voice therapy by Speech-Language Pathology, although corticosteroids are often
implemented in conjunction with voice therapy to reduce focal inflammation at the lesion
site. Operating room procedures are the traditional method to administer corticosteroids to
the lesion site, although recent advances in office-based laryngeal steroid injections have
become a widely popular alternative to reduce lesion size. Unfortunately, although in-office
injections are more favorable to operating room procedures, due to their less invasive
nature, in-office procedures are still an invasive alternative in the pediatric population.
Specifically, they involve equipment that may be intimidating to the child and require the
child to remain very still for prolonged periods of time, which may not be feasible with some
children. Furthermore, focal vocal fold injections still involve potential adverse effects
such as vocal fold hematoma. To mediate these concerns, a short course of inhaled
corticosteroids may be a safe and non-invasive alternative to reducing inflammation and
lesion size within the larynx. The goal of the present study is to determine the safety and
feasibility of a short-course of inhaled corticosteroids in addition to standard voice
therapy for treating vocal fold nodules. The study also aims to examine the effects of
inhaled corticosteroids on quality of life outcomes and acoustic and aerodynamic outcomes.

Inclusion Criteria:

- Newly diagnosed with vocal fold nodules;

- Considered behaviorally and cognitively appropriate by PI for voice therapy;

- English comprehension and production sufficient to participate in the protocol and in
voice therapy;

- Not currently on inhaled corticosteroids;

- No previous voice therapy;

- Willing to participate in voice therapy at Children's Hospital of Pittsburgh

Exclusion Criteria:

- Other medical conditions or medications that would mask or amplify voice outcomes,
including developmental or other neuromuscular conditions, major illness or disorders,
chronic or acute with the exception of laryngopharyngeal reflux disease or allergies
and their treatments.
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Pittsburgh, Pennsylvania 15224
412-692-5325
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