Laryngomalacia Clinical Trial
Official title:
The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia
Verified date | November 2013 |
Source | Tel-Aviv Sourasky Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 12 Months |
Eligibility |
Inclusion Criteria: Infants referred for FLB and bronchoscopy due to congenital stridor at the Department of Pediatric Pulmonology, Critical Care and Sleep Medicine at the Tel Aviv Sourasky Medical Centre Exclusion Criteria: - Prior knowledge of the cause for stridor - History of foreign body aspiration |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The yield of US in diagnosing laryngomalacia in comparison to FLB. | December 2013- January 2015 (13 months) | No | |
Secondary | The yield of US in diagnosing other causes of congenital stridor compared to FLB. | December 2013- January 2015 (13 months) | No |
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