Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-08 @ 11:48 AM
Study NCT ID:
NCT04026360
Status:
RECRUITING
Last Update Posted:
2020-11-04
First Post:
2019-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Early Lung Physiology, Viral Infections and the Microbiota on the Development and Progression of Lung Disease in Children With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Oropharyngeal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2050-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multiple Breath Washout', 'timeFrame': 'Every third year from the age of 4-8 weeks/1 year till 18 years.', 'description': 'Longitudinal assessment of lung volume and ventilation inhomogeneity'}, {'measure': 'Spirometry', 'timeFrame': 'Every third year from the age of 4-8 weeks/1 year till 18 years.', 'description': 'Longitudinal assessment of long volumes.'}, {'measure': 'Body plethysmography', 'timeFrame': 'Every third year from the age of 4-8 weeks/1 year till 18 years.', 'description': 'Longitudinal assessment of ventilation inhomogeneity.'}, {'measure': 'Magnetic Resonance Imaging (MRI)', 'timeFrame': 'At the age of 4-8 weeks, 1, 3, 6, 9, 12, 15 and 18 years', 'description': 'Longitudinal assessment of regional lung perfusion and ventilation'}, {'measure': 'Nasal swabs', 'timeFrame': 'At the age of 4-8 weeks, 1, 3, 6, 9, 12, 15 and 18 years', 'description': 'Longitudinal assessment of viral and bacterial colonization of the nasal swab'}, {'measure': 'Weekly swabs', 'timeFrame': 'Weekly from the visit at the age of 4-8 weeks till the age of 1 year', 'description': 'Respiratory virus and bacterial diagnostic'}, {'measure': 'Swabs during respiratory infection', 'timeFrame': 'From the visit at the age of 4-8 weeks till the age of 1 year', 'description': 'Respiratory viruses and Bacteria, changes of the microbial flora'}, {'measure': 'Routine swabs in CF', 'timeFrame': 'At the age of 4-8 weeks, 1 year and at each 3-monthly clinic visit during the age of 3, 6, 9, 12, 15 and 18 years', 'description': 'Longitudinal assessment of bacterial changes, changes of the resistome (genes conferring antibiotic resistance) and the changes of the microbial flora'}], 'secondaryOutcomes': [{'measure': 'Respiratory Rate (RR)', 'timeFrame': 'From the visit at the age of 4-8 weeks till the age of 1 year', 'description': 'The number of breaths over 60 seconds'}, {'measure': 'Sweat test', 'timeFrame': 'At the age of 3, 6, 9, 12, 15 and 18 years', 'description': 'Sweat Chloride concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infants', 'Cystic Fibrosis', 'Inflammation', 'Microbiome', 'Airway growth', 'Airway development', 'Genetic predisposition', 'Tobacco'], 'conditions': ['Confirmed Diagnosis of Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'This study collects data on microbiological factors and lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess their interaction on the lung growth and lung development of infants and children with Cystic Fibrosis (CF).', 'detailedDescription': "Background:\n\nCystic fibrosis (CF) is the most common lethal inherited disease in North European populations, affecting approximately 1:2500 live births. It is a multisystem disorder with respiratory morbidity and mortality being the leading cause of death. Lung disease in CF is characterized by neutrophil-dominated inflammation and chronic bacterial infection of the airways, which results in deterioration of lung function and premature death \\[1\\]. Despite improved survival in successive birth cohorts, the current median survival age of patients with CF is about 40 years \\[2\\]. Understanding the initiating events of CF lung disease (e.g viral infections and microbiome) and their influence on disease progression throughout early childhood is essential to improve survival through targeted early interventions.\n\nObjectives:\n\nThe overarching aim of this study is to identify early life predictors of disease progression in children with CF. Therefore, this study implies three objectives, as follows: i) to investigate the effect of respiratory viral infections on microbiota dynamics in the first year of life in infants with CF, and to examine their influence on lung function at 1 year of age; ii) to examine whether deficits in lung function in the first year of life in infants with CF persist to pre- and school age and adolescence and are associated with impaired functional and structural abnormalities at 3, 6, 9, 12, 15 and 18 years of age; and iii) to determine the principal drivers of impaired lung function at 1 year and impaired lung function and structural outcomes at 3, 6, 9, 12, 15 and 18 years of age in individuals with CF.\n\nMethods:\n\nLung function, magnetic resonance imaging (MRI), respiratory symptoms and quality of life questionnaires, microbiology, medical history and clinical data will be collected during each phase of the study.\n\nRecruitment and participation:\n\nInfants with CF diagnosed by NBS will be recruited at the time of their first lung function test in Bern at the age of 4-8 weeks. As part of the protocol for the diagnosis and follow-up of CF infants diagnosed by NBS, which has been implemented by the Task Force for CF NBS on behalf of the Swiss Working Group for Cystic Fibrosis, optional infant lung function at the University Children's Hospital of Bern is proposed to all parents of newly diagnosed CF infants.\n\nInformation collected:\n\nLung function data:\n\n* Tidal breathing parameters (minute ventilation, respiratory rate, tidal volume, tidal expiratory flow, tidal inspiratory flow, time to peak expiratory flow) averaged over 100 breaths\n* Multiple breath washout (FRC, LCI, moment ratios) and single breath washout (molar mass)\n* Spirometric forced expiratory volume loops (FVC, FEV1, PEF, MEF50)\n* Body plethysmography (airway resistance, lung volumes: TLC, FRC, RV)\n* Respiratory Rate over 60 seconds\n* Fractional exhaled nitric oxide (marker of airway inflammation)\n* Resistance interrupter measurement\n* Electric nose\n* Forced oscillation technique\n* Electrical impedance tomography\n* Impedance plethysmography\n\nMicrobiological data:\n\n* Nasal swabs (respiratory virus and bacterial diagnostics, as well as host transcriptome analysis)\n* Pharyngeal swabs (bacterial colonization and microbiota analysis)\n* Sputum (to analyse the neutrophils)\n\nBlood count (hemoglobin concentration, hematocrit, leukocyte number, lymphocyte number, lymphocyte count, eosinophil count, basophil count, monocyte count, promyelocyte count, myelocyte count, platelet count, immunoglobulin E level, interleukins, Granulocyte-Monocyte-Colony Forming Unit, Tumor Necrosis Factor alpha, Interferon gamma and Interferon lambda)\n\nUrine (to estimate the tobacco exposure during pregnancy (amount of Cotinine) and the content of caffeine and steroid profile)\n\nLung MRI:\n\nFunctional and structural images of the lung\n\nSkin-Prick Test (test for pollen, trees, house dust mite, cat and dog)\n\nQuestionnaires (to assess quality of life)\n\nMedical history (information on respiratory symptoms, pulmonary exacerbations, hospitalisations and regular therapy)\n\nStudy database:\n\nAll study data is recorded in an Access-database with SQL Servers by electronic Case Report Forms. The database is accordant to the HFG and was adapted together with the CTU.\n\nFunding:\n\nSchweizerischer Nationalfonds (SNF), Schweizerische Gesellschaft für Cystische Fibrose (CFCH), Departement Lehre und Forschung des Inselspitals Bern"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cystic Fibrosis Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants with a confirmed diagnosis of CF by NBS\n* Age \\<=18 years\n* Written informed consent by patient and/or parent\n\nExclusion Criteria:\n\n* Need for respiratory support for more than three days\n* Severe malformations or known diseases other than CF\n* Maternal drug abuse\n* Known severe maternal disease\n* Severe Problems of communication\n* Pacemaker, continuous glucose monitor'}, 'identificationModule': {'nctId': 'NCT04026360', 'acronym': 'SCILD', 'briefTitle': 'Impact of Early Lung Physiology, Viral Infections and the Microbiota on the Development and Progression of Lung Disease in Children With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Impact of Early Lung Physiology, Viral Infections and the Microbiota on the Development and Progression of Lung Disease in Children With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'SCILD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Philipp Latzin, MD PhD', 'role': 'CONTACT', 'email': 'philipp.latzin@insel.ch', 'phone': '0041 31 632 94 93'}], 'facility': "University Children's Hospital Bern", 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Philipp Latzin, MD PhD', 'role': 'CONTACT', 'email': 'philipp.latzin@insel.ch', 'phone': '0041 31 632 94 93'}], 'overallOfficials': [{'name': 'Philipp Latzin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital Bern"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, {'name': 'Kantonsspital Aarau', 'class': 'OTHER'}, {'name': "University Children's Hospital Basel", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}