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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01991964
Other study ID # TASMC-13-FS-0563-13-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 18, 2013
Last updated November 21, 2013
Start date December 2013

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
laryngeal ultrasound


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

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
See also
  Status Clinical Trial Phase
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Recruiting NCT05839756 - Predicting Post Extubation Stridor After Maxillomandibular Fixation N/A
Not yet recruiting NCT02056379 - Comparison Between Budesonide and Dexamethasone Treatments for Respiratory Discomfort After Extubation on Children N/A
Completed NCT02523820 - Nebulized Corticosteroid for Post Extubation Stridor in Children Phase 3
Withdrawn NCT02700087 - In Infants With Laryngomalacia, Does Acid-Blocking Medication Improve Respiratory Symptoms? N/A
Recruiting NCT06212037 - POCUS of the Pediatric Critical Airway