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The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01991964
Enrollment
40
Registered
2013-11-25
Start date
2013-12-31
Completion date
Unknown
Last updated
2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngomalacia, Stridor

Keywords

stridor, laryngomalacia, ultrasound

Brief summary

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.

Interventions

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The yield of US in diagnosing laryngomalacia in comparison to FLB.December 2013- January 2015 (13 months)

Secondary

MeasureTime frame
The yield of US in diagnosing other causes of congenital stridor compared to FLB.December 2013- January 2015 (13 months)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026