Risk Factors and Prognostic Parameters of Interstitial Lung Disease in Children

NCT ID: NCT06125288

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-02-28

Brief Summary

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Study the severity and outcome of children with interstitial lung disease

Detailed Description

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The child interstitial lung diseases (chILD) are a group of chronic lung diseases resulting from pathological changes of alveolar wall and capillary units.The epidemiology of the various forms of chILD is difficult to establish. small studies have suggested an approximate incidence of 0.5-0.8 cases per 100 000 children The prevalence is estimated to be 3.6 and 1.32 per million in the UK and Germany, respectively. but there are no recorded studies for its prevalence in Egypt due to the lack of standardized definitions , the inadequacy of organized reporting systems, and the variety of pathological conditions. In addition, clinical presentation is often nonspecific, contributing to a poor recognition of these disorders and confusion with other chronic pulmonary diseases .

childhood interstitial lung disease may be considered if the child meets at least three of the criteria presented (1) Respiratory symptoms (e.g., cough, difficult breathing, exercise intolerance). (2). Respiratory signs (e.g., retractions, tachypnea, clubbing, failure to thrive). (3). Hypoxemia. (4). Diffuse parenchymal abnormalities on chest imaging .

The causes of chILD often remain undetermined. These diffuse lung disorders are chronic, and often have high morbidity and mortality .

Mortality from childhood interstitial lung diseases ranges from 15 to 60% in different research reaching up to 100% in genetic and developmental causes.

There are many challenges and uncertainties for the early and correct diagnosis of interstitial lung disease in the pediatric patient. Three major challenges include, First , the fact that interstitial lung disease is less common in infants and children compared with adults. Therefore, most clinicians and radiologists are less familiar with considering and recognizing interstitial lung disease in this patient population.

Second, the clinical manifestations of interstitial lung disease particularly in infants and the young child are often subtle, highly variable, and typically nonspecific, such as dyspnea, tachypnea, crackles, and hypoxemia.

Lastly, there are currently no pathognomonic clinical or laboratory criteria for the diagnosis of interstitial lung disease in pediatric patients.

Some of the major uncertainties involving interstitial lung disease in this population include the decrease of information regarding the natural history of interstitial lung disease in childhood,the lack of understanding of the role of specific host factors in the pathogenesis of interstitial lung disease, and the absence of information on prognostic indicators in interstitial lung disease in childhood and more particularly in infants. Due to the above-stated challenges and uncertainties, evaluation and diagnosis of interstitial lung disease in childhood and particularly in infants has been markedly limited in the past.

Interstitial lung diseases may be classified a specific, suspicious, or non -specific diagnosis . A specific diagnosis was assigned to those cases in which a diagnosis was made with confidence based on careful consideration of clinical presentation , laboratory evaluations, and invasive diagnostic studies , such as lung biopsy.

A suspicious diagnosis was assigned to those cases in which the clinical presentation suggested a disorder (such as hypersensitivity pneumonitis from bird exposure) that could not be confirmed conclusively by diagnostic evaluation.

Non - specific diagnosis was assigned to those cases in which no specific or suspicious diagnosis could be made despite complete diagnostic evaluation.

The appropriate and definitive investigation are lung biopsy in order to establish a precise diagnosis so At our hospital, we face many obstacles regarding the diagnosis .

The present study will be on suspicious and specific groups

Conditions

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Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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lab investigation and radiation

1. . Full history taking including

* Environmental factors such as long term exposure to environmental hazards as bacteria, fungi, chemicals, tobacco smoke and air pollution.
* Host factors Family history (you have a higher risk of ILD if a close relative has ILD). History of recurrent chest infection. History of exposure to medication such as radiation and chemotherapy. History of Multisystem autoimmune diseases
2. Full examination general and systemic especially chest examination
3. investigation

* pulse oximetry.
* lab investigation include complete blood count parameters .
* radiological investigation including ( echocardiography - MSCT chest - chest -x ray

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Suspected cases with:

1. tachypnea , Hypoxemia less than 90% in room air , rales and wheezes in absence of chest infection , retraction or deformed chest wall .
2. pulmonary hypertension by ECG or echocardiography.
3. x-ray and CT chest infiltrates.
4. Duration of illness more than 1 month.

Specific cases with:

1. symptoms and signs of suspected cases.
2. Lung biopsy.

\-

Exclusion Criteria

* congenital heart disease.
* bronchopulmonary dysplasia.
* Telangiectasia.
* Duration of illness less than 1 month
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Reham kamal hamdi mohamed

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maher Mokhtar Ahmed, Professor

Role: STUDY_DIRECTOR

asiut university hospital

Central Contacts

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REHAM KAMAL HAMDI

Role: CONTACT

01065329519

. Yasser Gamal Abd El-Rahman, lecturer

Role: CONTACT

01006238575

References

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Fan LL, Kozinetz CA. Factors influencing survival in children with chronic interstitial lung disease. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):939-42. doi: 10.1164/ajrccm.156.3.9703051.

Reference Type BACKGROUND
PMID: 9310017 (View on PubMed)

Clement A, Henrion-Caude A, Fauroux B. The pathogenesis of interstitial lung diseases in children. Paediatr Respir Rev. 2004 Jun;5(2):94-7. doi: 10.1016/j.prrv.2004.01.002.

Reference Type BACKGROUND
PMID: 15135117 (View on PubMed)

Bush A, Cunningham S, de Blic J, Barbato A, Clement A, Epaud R, Hengst M, Kiper N, Nicholson AG, Wetzke M, Snijders D, Schwerk N, Griese M; chILD-EU Collaboration. European protocols for the diagnosis and initial treatment of interstitial lung disease in children. Thorax. 2015 Nov;70(11):1078-84. doi: 10.1136/thoraxjnl-2015-207349. Epub 2015 Jul 1.

Reference Type BACKGROUND
PMID: 26135832 (View on PubMed)

Other Identifiers

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ILD in children

Identifier Type: -

Identifier Source: org_study_id

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