Laryngomalacia Clinical Trial
Official title:
The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia
The hypothesis of the study is that laryngeal US can accurately and reliably diagnose
laryngomalacia in infants with congenital stridor.
Stridor is a respiratory noise caused by partial obstruction of the large airways at the
level of the pharynx, larynx and/or trachea. The most prevalent congenital cause of stridor
is laryngomalacia. Flexible laryngobronchoscopy (FLB) under sedation is regarded as the gold
standard. However, FLB under sedation has some drawbacks as it requires venous access, use
of sedative agents, may cause discomfort for the patient and is costly.
Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging
technique. It allows for dynamic assessment of moving structures in an awake patient and the
results can be easily displayed and recorded.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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