Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-07 @ 1:32 PM
Study NCT ID:
NCT02636933
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2015-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2015-10-02', 'studyFirstSubmitQcDate': '2015-12-18', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced oscillation technique', 'timeFrame': 'Baseline, 24 months, and 48 months', 'description': 'Longitudinal assessment of forced oscillation technique (FOT)'}, {'measure': 'Spirometry', 'timeFrame': 'Baseline, 24 months, and 48 months', 'description': 'Longitudinal assessment of spirometry'}, {'measure': 'Interrupter resistance', 'timeFrame': 'Baseline, 24 months, and 48 months', 'description': 'Longitudinal assessment of interrupter resistance (RINT)'}], 'secondaryOutcomes': [{'measure': 'Nasal nitric oxide', 'timeFrame': 'Baseline, 24 months, and 48 months', 'description': 'Longitudinal assessment of nasal nitric oxide (nNO)'}, {'measure': 'Atopy', 'timeFrame': 'Baseline', 'description': 'Positivity to at least one aeroallergen'}, {'measure': 'Nasal brushing', 'timeFrame': 'Baseline', 'description': 'Assessment of alterations and inflammatory changes in the nasal mucosa'}, {'measure': 'Saliva sample', 'timeFrame': '24 months, and 48 months', 'description': 'Phenotypic characterization through the collection of saliva samples'}, {'measure': 'Urine analysis', 'timeFrame': 'Baseline, 24 months, and 48 months', 'description': 'Endotypic characterization through urine proteomic analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Allergic Rhinitis', 'Children', 'Atopy'], 'conditions': ['Asthma', 'Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.', 'detailedDescription': 'The PRE-AR project is a longitudinal observational study. The primary objective is the assessment of lung function parameters in late preterm preschool children.\n\nPulmonary function tests will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A study population of 59 prematurely born children (of both sex and 3-5 years old) attending as outpatient clinic of Pediatric Allergology \\& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR).\n\nA Control group of full-term born children (N=93), recruited by a collaborative Pediatricians network within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.\n\nThe subjects will be paired up according to the sex and to the age, with a ratio 1:1.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Case group\n\nInclusion Criteria:\n\n* Premature birth \\< 37 weeks\n* 5 years old ≤ Age ≥ 3 years old\n\nControl group\n\nInclusion Criteria:\n\n* Full-term birth\n* 5 years old ≤ Age ≥ 3 years old\n\nExclusion Criteria of both groups:\n\n* Pulmonary bronchodysplasia (BDP)\n* Acute respiratory infection\n* Immunological and metabolic system disease\n* Malformation of upper respiratory tract\n* Topical or systemic therapies, with antibiotics, antihistaminics and corticosteroids, in the previous 30 days\n* Patients with neurological pathologies\n* Patients that are not able to perform the lung function tests'}, 'identificationModule': {'nctId': 'NCT02636933', 'briefTitle': 'Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters', 'organization': {'class': 'OTHER', 'fullName': "Istituto per la Ricerca e l'Innovazione Biomedica"}, 'officialTitle': 'Longitudinal Observational Study in Prematurely Born Preschool Children: Assessment of Lung Function Parameters (PRE-AR) (PREMATURELY BORN CHILDREN- ASTHMA AND ALLERGIC RHINITIS )', 'orgStudyIdInfo': {'id': '9/2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': '59 prematurely born children', 'description': 'Lung function assessment of 59 prematurely born children (of both sex and 3-5 years old) attending as outpatient clinic of Pediatric Allergology \\& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR)', 'interventionNames': ['Other: Lung Function Assessment']}, {'label': '93 full-term born children', 'description': 'Lung function assessment of a Control group of full-term born children (N=93), recruited by a collaborative Pediatricians network within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.', 'interventionNames': ['Other: Lung Function Assessment']}], 'interventions': [{'name': 'Lung Function Assessment', 'type': 'OTHER', 'description': 'Lung Function Assessment', 'armGroupLabels': ['59 prematurely born children', '93 full-term born children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90146', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Institute of Biomedicine and Molecular Immunology, IBIM', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The IPD collected will be available on december 2020.\n\nThe following participant data will be shared:\n\n* Pulmonary function tests\n* Demographic characteristics\n\nAll IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stefania La Grutta, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.', 'investigatorFullName': 'Stefania La Grutta, MD', 'investigatorAffiliation': "Istituto per la Ricerca e l'Innovazione Biomedica"}}}}