Intraoperative Laryngeal Electromyography (LEMG) in Children With Vocal Fold Immobility: a Longitudinal Study

Completed

Conditions studied: Vocal Fold Immobility

In brief

The goal of this study is to further study the role of LEMG in accurately predicting the recovery of vocal function as well to study the timing of a change of LEMG activity prior to such return of function. We aim to do this by collaborating with several active pediatric otolaryngological practices throughout the country who in turn have agreed to evaluate infants and children with vocal fold immobility who fit a standardized inclusion and exclusion criteria by means of a standardized LEMG protocol over a one year period of time. Our particular goal is to collect and then review information over a one year period of time on all children evaluated for vocal fold immobility by means of LEMG.

Key facts

Study ID

NCT00771186

Run by

Massachusetts Eye and Ear Infirmary

People needed

40

Starts

2008-01-01

Expected to finish

2009-12-01

Last updated by the study team

2010-06-22

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children age 0-18 with vocal fold immobility documented by laryngeal fiberoptic evaluation
• Children who have had a recent, identifiable cardiac surgical etiology for RLN injury and subsequent VFI
• Children whose parents sign informed consent and who themselves sign assent if they are old enough to do so

You may not qualify if…

• Children whose families do not give informed consent or who themselves do not give informed assent ( if the children are old enough to understand)
• Children with congenital VFI where the etiology is not clearly identified

Where it is running

• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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