Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
Study NCT ID:
NCT06455800
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2024-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Severe Lung Disease in Childhood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '18 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2039-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2024-05-14', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1', 'timeFrame': '18 years', 'description': 'liter'}, {'measure': 'FVC', 'timeFrame': '18 years', 'description': 'liter'}, {'measure': 'Lung Clearance Index (LCI)', 'timeFrame': '18 years', 'description': 'number'}], 'secondaryOutcomes': [{'measure': 'height', 'timeFrame': '18 years', 'description': 'meters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Disease Chronic']}, 'descriptionModule': {'briefSummary': '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.\n\nThis observational study will investigate which parameters that can be used to predict the outcome of having severe lung disease in childhood.', 'detailedDescription': 'All patients aged 0-18 years at the HCA Childrens Hospital with a severe lung disease will prospectively be registered in a database.\n\nAt 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.\n\nThe study will provide knowledge of the prognosis of different lung diseases and how to monitor lung function in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe chronic lung desease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: severe lung disease -\n\nExclusion Criteria: no informed consent\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06455800', 'briefTitle': 'Severe Lung Disease in Childhood', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Long Term Outcome of Severe Lung Disease in Childhood', 'orgStudyIdInfo': {'id': 'HCA-Lung'}}, 'armsInterventionsModule': {'interventions': [{'name': 'lung function measurements', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will once a year be monitored with different lung function methods'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Josefine Gradman, PhD', 'role': 'CONTACT', 'email': 'josefine.gradman@rsyd.dk', 'phone': '0045 29241375'}], 'facility': "Hans Christian Andersen Children's Hospital", 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Josefine Gradman, PhD', 'role': 'CONTACT', 'email': 'josefine.gradman@rsyd.dk', 'phone': '0045 29241375'}], 'overallOfficials': [{'name': 'Josefine Gradman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}