NCT06603584

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 17, 2024

Last Update Submit

September 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume

    Changes in Forced Expiratory Volume in bronchial Asthmatic Patient

    6 months

Study Arms (4)

group A

Bronchial Asthma

Radiation: Chest x- Rays

group B

Chronic Aspiration

Radiation: Chest x- Rays

group C

Primary Ciliary Dyskinesia

Radiation: Chest x- Rays

group D

Cystic Fibrosis

Radiation: Chest x- Rays

Interventions

Chest x- RaysRADIATION

prebronchial Thicknening - Right upper lobe Patches suggesting Aspiration -Collapsing lobe

group Agroup Bgroup Cgroup D

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

\- patients from the age of one to five years with recurrent wheezing

You may qualify if:

  • patients from the age of one to five years with recurrent wheezing

You may not qualify if:

  • Children above 5 years and below one year old.
  • Failure to obtain informed consent.
  • Children below 6 years with chest diseases other than wheezing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30267890BACKGROUND
  • 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.

    PMID: 15502115BACKGROUND
  • 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.

    PMID: 37873657BACKGROUND
  • 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.

    PMID: 30640211BACKGROUND

MeSH Terms

Conditions

Respiratory Sounds

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Central Study Contacts

Amr A Farghal, resident

CONTACT

Mostfa A Mohammed, assistant professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-pediatric department-sohag hospital university

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 19, 2024

Study Start

June 4, 2024

Primary Completion

April 4, 2025

Study Completion

April 4, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

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