Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352944
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-03
Brief Title:
Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Bronchoscopic Derived Bronchoalveolar Lavage Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers functional and radiological severity
Detailed Description:
The severity of bronchiectasis will be assessed using forced expiratory volume in 1s FEV1 and bronchiectasis severity scores which included bronchiectasis severity index BSI FEV1 chronic colonization extension of lobes and dyspnea which were performed to assess non-CF bronchiectasis patients
BSI score
This score incorporates 9 variables The total score is calculated by summing the scores for each variable and can range from 0 to 26 points According to the overall score patients are classified into three classes patients with low BSI score 0---4 points intermediate BSI score 5---8 points high BSI score 9 points
chest X ray and HRCT of the chest to assess the radiological severity of bronchiectasis using the radiological findings will be measured by assessing the most recent chest X ray and HRCT of the chest performed in the last six months using Bhalla score10
Culture and sensitivity from bronchoalveolar lavage for isolation of pseudomonas aeruginosa and any other organism
Sputum procalcitonin level was measured in BAL samples using bronchoscopy
Bronchoscopy would be undertaken when the children were in a stable clinical condition as part of their annual review
BSI score
This score incorporates 9 variables The total score is calculated by summing the scores for each variable and can range from 0 to 26 points According to the overall score patients are classified into three classes patients with low BSI score 0---4 points intermediate BSI score 5---8 points high BSI score 9 points
chest X ray and HRCT of the chest to assess the radiological severity of bronchiectasis using the radiological findings will be measured by assessing the most recent chest X ray and HRCT of the chest performed in the last six months using Bhalla score10
Culture and sensitivity from bronchoalveolar lavage for isolation of pseudomonas aeruginosa and any other organism
Sputum procalcitonin level was measured in BAL samples using bronchoscopy
Bronchoscopy would be undertaken when the children were in a stable clinical condition as part of their annual review
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None