Risk Factors and Prognostic Parameters of Interstitial Lung Disease in Children

Interstitial Lung Disease Clinical Trial

Official title:

Assessment of Severity of Interstitial Lung Disease (ILD) in Children: Analytical Study of Risk Factors and Prognostic Parameters

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06125288
• Other study ID #: ILD in children
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: REHAM KAMAL HAMDI
• Phone: 01065329519
• Email: mother2524019[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study the severity and outcome of children with interstitial lung disease

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria: All children more than 1 month and less than 18 years of age.

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:• All children less than 1 month and more than 18 years

• congenital heart disease.
• bronchopulmonary dysplasia.
• Telangiectasia.
• Duration of illness less than 1 month

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• lab investigation and radiation
. 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 Full examination general and systemic especially chest examination investigation pulse oximetry. lab investigation include complete blood count parameters . radiological investigation including ( echocardiography - MSCT chest - chest -x ray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of pediatric patient suffering from complication of interstitial lung disease at assiut university hospital.	number of patiants present to assiut university with clinical complication (tachycardia -tachapnnea -dysnea - cyanosis ) and lab complication by complete blood count and radiological complication by ( chest x ray - chest msct -echocardiography).	baseline