Status:
RECRUITING
Use of Nasal Nitric Oxide Testing in Improving Primary Ciliary Dyskinesia Clinical Care
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Conditions:
Primary Ciliary Dyskinesia
Eligibility:
All Genders
2-99 years
Brief Summary
this study is aiming at learning more about primary ciliary dyskinesia (PCD) and tests that are used to diagnose this condition. One purpose of this study is to measure the level of nitric oxide in th...
Detailed Description
This will be an observational study. Participants who are referred by their clinician for nasal NO testing and meet the inclusion and exclusion criteria will be allowed to undergo testing. Informed co...
Eligibility Criteria
Inclusion
- Individuals who are diagnosed with Primary Ciliary Dyskinesia OR
- Individuals with abnormal PCD diagnostics (abnormal ciliary biopsy or PCD genetics) OR
- Individuals with unexplained bronchiectasis OR
- Individuals undergoing PCD diagnostic testing (ciliary biopsy, PCD genetic testing) or concern based on clinical symptoms (at least two of the following):
- Neonatal respiratory distress
- Organ laterality defects
- Year-round cough starting in first year of life or bronchiectasis on chest CT
- Year-round nasal congestion starting in first year of life or pansinusitis
- Multiple ear infections in the first two years of life with sequelae (e.g. ear tubes, chronic effusion, abnormal audiological exam)
- History of recurrent pneumonias (at least 2 in one year or more than 3 at any time)
- Ability to provide consent for participation in study by the participants or guardian
- Ability to perform the test
- Age \>= 2 years of age
Exclusion
- Individuals who are unable to understand the requirements of the study.
- Individuals (or guardians) who are unwilling to provide consent.
- Individuals who are unable to complete the testing
- Recent history of sinus surgery (within four weeks) or bloody nose (within one week) of testing (they can be included at a later date)
- Patients who are currently being treated (within one week) with antibiotics for sinusitis or respiratory symptoms (they can be included at a later date)
- Age \<2 years of age
Key Trial Info
Start Date :
June 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05287022
Start Date
June 14 2021
End Date
June 1 2030
Last Update
January 30 2025
Active Locations (1)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202