Severe Lung Disease in Childhood

Lung Disease Chronic Clinical Trial

Official title:

Long Term Outcome of Severe Lung Disease in Childhood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455800
• Other study ID #: HCA-Lung
• Status: Recruiting
• Start date: August 1, 2024
• Est. completion date: December 31, 2040

Study information

• Verified date: June 2024
• Source: Odense University Hospital
• Contact: Josefine Gradman, PhD
• Phone: 0045 29241375
• Email: josefine.gradman[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Only little information exists about the long term consequences of having severe lung disease in childhood. The patient population is heterogenous and the prognostic markers are few. This observational study will investigate which parameters that can be used to predict the outcome of having severe lung disease in childhood.

Description:

All patients aged 0-18 years at the HCA Childrens Hospital with a severe lung disease will prospectively be registered in a database. At a yearly follow up, data from the patient record will be registered. Informed consent from the patients and/or their parents will be obtained. Registered data will include height, weight, results of lung function tests and imaging diagnostics. The study will provide knowledge of the prognosis of different lung diseases and how to monitor lung function in children.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2040
• Est. primary completion date: December 31, 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

Inclusion Criteria: severe lung disease - Exclusion Criteria: no informed consent -

Related Conditions & MeSH terms

• Lung Disease Chronic
• Lung Diseases

Intervention

Diagnostic Test:
• lung function measurements
Patients will once a year be monitored with different lung function methods

Locations

Country	Name	City	State
Denmark	Hans Christian Andersen Children's Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1	liter	18 years
Primary	FVC	liter	18 years
Primary	LCI	number	18 years
Secondary	height	meters	18 years