- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06603584
Phenotypes of Preschool Wheezing Among Children Attending Sohag University Hospital
September 17, 2024 updated by: Amr Ahmed Gamal Eldin, Sohag University
Wheezing in preschool children is very common, with a wide differential diagnosis.
It is essential to be sure of the exact sound that parents are describing; the term 'wheeze' is often applied to non-specific sound.Approximately one-third of children are diagnosed with wheeze in the first 3 years of life, making wheeze one of the commonest respiratory symptoms.The differential diagnosis of wheeze is wide, and different management strategies are needed depending on the underlying phenotype.
The word 'wheeze' is used to describe many different sounds.
That can be heard by both clincians and parent.
Even if true wheeze is heard, this should not be automatically assumed to be due to bronchospasm.
Airway narrowing by mucus will produce true wheeze but does not respond to bronchodilators.
Similarly, airway malacia, either related to intrinsic airway wall defects or loss of alveolar tethering points, are also causes of bronchodilatorunresponsive wheeze; indeed, bronchodilators, by reducing airway smooth muscle tone, may actually worsen airway narrowing.
Study Overview
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amr A Farghal, resident
- Phone Number: 01020479524
- Email: amrahmed@med.sohag.edu.eg
Study Contact Backup
- Name: Mostfa A Mohammed, assistant professor
Study Locations
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-
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Sohag, Egypt
- Recruiting
- Sohag University Hospital
-
Contact:
- Magdy M Amin, professor
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
- patients from the age of one to five years with recurrent wheezing
Description
Inclusion Criteria:
- patients from the age of one to five years with recurrent wheezing
Exclusion Criteria:
- Children above 5 years and below one year old.
- Failure to obtain informed consent.
- Children below 6 years with chest diseases other than wheezing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group A
Bronchial Asthma
|
prebronchial Thicknening - Right upper lobe Patches suggesting Aspiration -Collapsing lobe
|
|
group B
Chronic Aspiration
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prebronchial Thicknening - Right upper lobe Patches suggesting Aspiration -Collapsing lobe
|
|
group C
Primary Ciliary Dyskinesia
|
prebronchial Thicknening - Right upper lobe Patches suggesting Aspiration -Collapsing lobe
|
|
group D
Cystic Fibrosis
|
prebronchial Thicknening - Right upper lobe Patches suggesting Aspiration -Collapsing lobe
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Expiratory Volume
Time Frame: 6 months
|
Changes in Forced Expiratory Volume in bronchial Asthmatic Patient
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fitzpatrick AM, Bacharier LB, Guilbert TW, Jackson DJ, Szefler SJ, Beigelman A, Cabana MD, Covar R, Holguin F, Lemanske RF Jr, Martinez FD, Morgan W, Phipatanakul W, Pongracic JA, Zeiger RS, Mauger DT; NIH/NHLBI AsthmaNet. Phenotypes of Recurrent Wheezing in Preschool Children: Identification by Latent Class Analysis and Utility in Prediction of Future Exacerbation. J Allergy Clin Immunol Pract. 2019 Mar;7(3):915-924.e7. doi: 10.1016/j.jaip.2018.09.016. Epub 2018 Sep 26.
- Lowe LA, Simpson A, Woodcock A, Morris J, Murray CS, Custovic A; NAC Manchester Asthma and Allergy Study Group. Wheeze phenotypes and lung function in preschool children. Am J Respir Crit Care Med. 2005 Feb 1;171(3):231-7. doi: 10.1164/rccm.200406-695OC. Epub 2004 Oct 22.
- Salehian S, Fleming L, Saglani S, Custovic A. Phenotype and endotype based treatment of preschool wheeze. Expert Rev Respir Med. 2023 Jul-Dec;17(10):853-864. doi: 10.1080/17476348.2023.2271832. Epub 2023 Nov 24.
- Kwong CG, Bacharier LB. Phenotypes of wheezing and asthma in preschool children. Curr Opin Allergy Clin Immunol. 2019 Apr;19(2):148-153. doi: 10.1097/ACI.0000000000000516.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 4, 2024
Primary Completion (Estimated)
April 4, 2025
Study Completion (Estimated)
April 4, 2025
Study Registration Dates
First Submitted
September 17, 2024
First Submitted That Met QC Criteria
September 17, 2024
First Posted (Estimated)
September 19, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 17, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-Med-24-06-20MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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