Status:

TERMINATED

Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children

Lead Sponsor:

State University of New York - Upstate Medical University

Conditions:

Chronic Sinusitis

Adenoid Disease - Chronic

Eligibility:

All Genders

6-12 years

Phase:

NA

Brief Summary

The objectives of this study would be to determine the most effective management for pediatric patients with chronic rhinosinusitis and asthma who fail medical management. The Sinus and Nasal Quality ...

Detailed Description

Indications for surgery for pediatric chronic rhinosinusitis currently lacks scientific consensus. In general, children who fail medical management are candidates for surgery. Currently, pre-operative...

Eligibility Criteria

Inclusion

  • Age 6-12 at time of study enrollment.
  • Presence of chronic sinusitis: \>90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough
  • Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist
  • Failure of medical management of pediatric chronic rhinosinusitis, which current guidelines recommend extended empiric antibiotics for 21 days, which will be either Augmentin or clindamycin in penicillin allergic patients, at standard pediatric weight based dosing. In addition, Flonase nasal spray and nasal saline treatment for three weeks. Failure is considered persistent symptoms despite treatment with the above within the past year.

Exclusion

  • Previous sinus surgery,
  • Previous adenoidectomy, or
  • Presence of cystic fibrosis,
  • Presence of antrochoanal polyp,
  • Immunodeficiency
  • Fungal infection.

Key Trial Info

Start Date :

July 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2020

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT03336671

Start Date

July 1 2017

End Date

July 1 2020

Last Update

October 13 2021

Active Locations (1)

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1

SUNY Upstate Medical University

Syracuse, New York, United States, 13202