NCT06455800

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
167mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress9%
Dec 2024Dec 2039

First Submitted

Initial submission to the registry

May 14, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2039

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2039

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

15.1 years

First QC Date

May 14, 2024

Last Update Submit

July 7, 2025

Conditions

Lung Disease Chronic

Outcome Measures

Primary Outcomes (3)

  • FEV1

    liter

    18 years

  • FVC

    liter

    18 years

  • Lung Clearance Index (LCI)

    number

    18 years

Secondary Outcomes (1)

  • height

    18 years

Interventions

lung function measurementsDIAGNOSTIC_TEST

Patients will once a year be monitored with different lung function methods

Eligibility Criteria

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

Patients with severe chronic lung desease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hans Christian Andersen Children's Hospital

Odense, 5000, Denmark

RECRUITING

Study Officials

  • Josefine Gradman, PhD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Josefine Gradman, PhD

CONTACT

0045 29241375josefine.gradman@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2024

First Posted

June 12, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 31, 2039

Study Completion (Estimated)

December 31, 2039

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)