NCT06125288

Brief Summary

Study the severity and outcome of children with interstitial lung disease

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

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

First Submitted

Initial submission to the registry

November 6, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 6, 2023

Last Update Submit

November 9, 2023

Conditions

Outcome Measures

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).

    baseline

Interventions

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

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 9310017BACKGROUND
  • 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.

    PMID: 15135117BACKGROUND
  • 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.

    PMID: 26135832BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Radiation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Maher Mokhtar Ahmed, Professor

    asiut university hospital

    STUDY DIRECTOR

Central Study Contacts

REHAM KAMAL HAMDI

CONTACT

. Yasser Gamal Abd El-Rahman, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 9, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11