Interstitial Lung DiseaseNCT06125288
Risk Factors and Prognostic Parameters of Interstitial Lung Disease in Children
An observational study of Interstitial Lung Disease, run by Assiut University.
Trial summary
Study the severity and outcome of children with interstitial lung disease Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- lab investigation and radiation
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- Child, Adult
Study population: All children with suspected ILD that present to Assiut University Hospital Units
Inclusion Criteria: All children more than 1 month and less than 18 years of age.
Suspected cases with:
- tachypnea , Hypoxemia less than 90% in room air , rales and wheezes in absence of chest infection , retraction or deformed chest wall .
- pulmonary hypertension by ECG or echocardiography.
- x-ray and CT chest infiltrates.
- Duration of illness more than 1 month.
Specific cases with:
- symptoms and signs of suspected cases.
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Severity of Interstitial Lung Disease (ILD) in Children: Analytical Study of Risk Factors and Prognostic Parameters
Study the severity and outcome of children with interstitial lung disease
Read the detailed 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
- Conditions
- Interstitial Lung Disease
- Being tested
- lab investigation and radiation
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lab investigation and radiationOther
- . 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham kamal hamdi mohamed, Assiut University
- Investigators
- Maher Mokhtar Ahmed, Professor, Study director, asiut university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125288
- Sponsor's protocol ID
- ILD in children
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9310017Clement 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.
PubMed 15135117Bush 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.
PubMed 26135832
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Severity of Interstitial Lung Disease (ILD) in Children: Analytical Study of Risk Factors and Prognostic Parameters
- ClinicalTrials.gov ID
- NCT06125288
- Acronym / sponsor ID
- ILD in children
- Conditions
- Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study the severity and outcome of children with interstitial lung disease
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All children with suspected ILD that present to Assiut University Hospital Units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lab investigation and radiation1. . 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 | Other | – |
Primary outcome
number of pediatric patient suffering from complication of interstitial lung disease at assiut university hospital.
Time frame: baseline
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 9310017Fan 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.
- Background: PubMed 15135117Clement 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.
- Background: PubMed 26135832Bush 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maher Mokhtar Ahmed, Professor study director
asiut university hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact REHAM KAMAL HAMDI (01065329519, mother2524019@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of pediatric patient suffering from complication of interstitial lung disease at assiut university hospital. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06125288, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.