Dysphagia with Laryngeal Cleft: Management Protocols

Outcomes of Management of Type 1 Laryngeal Cleft (LC-1)

Protocol Description

Through this study investigators will compare the effectiveness of three alternatives in preventing food from entering the airway of children with Type 1 laryngeal cleft (LC-1), who have difficulty swallowing, a condition known as dysphagia. Laryngeal cleft is a split in the voice box. Through this study, researchers will look for traces of food in the airway before and after treatment by either diet change, medication or an injection laryngoplasty procedure, with a goal of determining what improvements are due to the procedure versus from normal development and maturation of swallowing processes.

Eligibility Criteria

Subject to exclusion criteria, the study is accepting children of both genders, up to age 17, who have dysphagia related to their LC-1 condition.
Males and Females: Up to age 17


Through this study, participants will receive a standard of care, as prescribed by their physician for treatment of dysphagia due to LC-1. Regardless of approach, at the initial visit and follow up visits, each participant’s parents/guardian will complete a questionnaire regarding the child’s health and well being, and the physician will complete a research datasheet describing the child’s symptoms, other relevant diagnoses, airway abnormalities, and the findings of swallowing tests. Follow-up visits will occur at intervals of 2 to 4 weeks and at 3 to 4 months following laryngoplasty or initiation of a management procedure.
Visits: 3
Duration: 4 months for follow up

Status: Open to Enrollment

Additional Information

Otolaryngology (ENT) Research

Primary Investigator

Allison Tobey, MD

Contact Information

For more information about the study or enrollment, please contact:
Amber Shaffer, PhD, Research Coordinator