Severe Lung Disease in Childhood

July 7, 2025 updated by: Odense University Hospital

Long Term Outcome of Severe Lung Disease in Childhood

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Recruiting
        • Hans Christian Andersen Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with severe chronic lung desease

Description

Inclusion Criteria: severe lung disease -

Exclusion Criteria: no informed consent

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1
Time Frame: 18 years
liter
18 years
FVC
Time Frame: 18 years
liter
18 years
Lung Clearance Index (LCI)
Time Frame: 18 years
number
18 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
height
Time Frame: 18 years
meters
18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Josefine Gradman, PhD, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 31, 2039

Study Completion (Estimated)

December 31, 2039

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCA-Lung

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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