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Status unknownNCT06125288Updated Nov 13, 2023

Risk Factors and Prognostic Parameters of Interstitial Lung Disease in Children

An observational study in Interstitial Lung Disease, sponsored by Assiut University. Status unknown. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
1 Month to 18 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Interstitial Lung Disease
03

In context

Lung Diseases, Interstitial

656 studies on the registry are indexed under Lung Diseases, Interstitial; 241 are open to participants now.

This study's planned enrollment of 25 is below the median of 150 across 273 observational studies indexed under Lung Diseases, Interstitial.

Browse Lung Diseases, Interstitial studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All children with suspected ILD that present to Assiut University Hospital Units

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Interventions

  • Otherlab 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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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 9310017 ↗
  • 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. PubMed 15135117 ↗
  • 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. PubMed 26135832 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2023; primary completion for Dec 2024, 12 months later.

Of 115 non-industry observational studies under Lung Diseases, Interstitial, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 274. This study's planned 12 months is below that.

Counting every sponsor, half of 132 studies reached it within 56 months; a quarter within 29 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2023
First posted
Nov 9, 2023
StartEst.
Dec 2023
Primary completionEst.
Dec 2024
CompletionEst.
Feb 2025
Last update
Nov 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06125288
Lead sponsor
Assiut University
Responsible party
Reham kamal hamdi mohamed (assistant lecturer, Assiut University) — Principal investigator
First posted
Nov 9, 2023
Start date
Dec 2023 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Feb 2025 (estimated)
Last update
Nov 13, 2023

Study contacts

REHAM KAMAL HAMDI
Contact
mother2524019@gmail.com
01065329519
. Yasser Gamal Abd El-Rahman, lecturer
Contact
Maher.Mokhtar.m.@gmail.com
01006238575
Maher Mokhtar Ahmed, Professor
study director · asiut university hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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