Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-25 @ 1:26 PM
Study NCT ID:
NCT06737159
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001988', 'term': 'Bronchiolitis'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants requiring oxygen supplementation', 'timeFrame': 'From admission to hospital discharge up to 2 weeks'}, {'measure': 'Duration of oxygen supplementation', 'timeFrame': 'From admission to hospital discharge up to 2 weeks', 'description': 'among those requiring oxygen'}, {'measure': "The time until the infant will be assessed as being 'fit for discharge'", 'timeFrame': 'From admission to hospital discharge up to 2 weeks', 'description': "which is defined as the point at which the infant will be feeding adequately (taking \\>75% of their usual intake based on parents' assessment) and will have a saturation of at least 92% for 6 h on room air, while the axillary body temperature will remain"}, {'measure': 'Worsening of clinical status, including the following', 'timeFrame': 'From admission to hospital discharge up to 2 weeks', 'description': 'PICU admission'}, {'measure': 'Adverse events, especially incidence of pneumonia', 'timeFrame': 'From admission to hospital discharge up to 2 weeks', 'description': 'which is defined as:\n\n* temperature increase (fever \\>38 )\n* deterioration of general condition\n* inflammatory changes in lung ultrasound or chest X-ray'}, {'measure': 'Hospital length of stay', 'timeFrame': 'From admission to hospital discharge up to 2 weeks', 'description': '(\\> 3 days)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchiolitis', 'bronchiolitis severity scoring', 'validation', 'utility'], 'conditions': ['Bronchiolitis']}, 'descriptionModule': {'briefSummary': 'Prospective observational study of patients hospitalized with bronchiolitis. The objective of our study is to compare the accuracy of commonly used clinical scales for bronchiolitis to predict relevant outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '5 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients with diagnosis of bronchiolitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren eligible for the trial must fulfil all of the following criteria:\n\n1\\. Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms:\n\n* Tachypnoea (WHO definition).\n* Increased respiratory effort manifested as follows:\n\n 1. Nasal flaring;\n 2. Grunting;\n 3. Use of accessory muscles;\n 4. Intercostal and/or subcostal chest wall retractions;\n 5. Apnoe.\n* Crackles and/or wheezing. 2. Aged 5 weeks - 24 months old.\n\nExclusion Criteria:\n\n1\\. Diagnosis or suspicion of asthma.'}, 'identificationModule': {'nctId': 'NCT06737159', 'briefTitle': 'Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis.', 'organization': {'class': 'OTHER', 'fullName': 'Szpital im. Św. Jadwigi Śląskiej'}, 'officialTitle': 'Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis: Prospective Multicentre Cohort Study.', 'orgStudyIdInfo': {'id': '4/PNDR/2023'}}, 'contactsLocationsModule': {'locations': [{'zip': '55-100', 'city': 'Trzebnica', 'country': 'Poland', 'contacts': [{'name': 'Henryk Szymański, MD, PhD', 'role': 'CONTACT', 'email': 'henryk.t.szymanski@gmail.com', 'phone': '0048604467073'}, {'name': 'Aleksandra Buczek, MD', 'role': 'CONTACT'}], 'facility': 'Szpital im. Św. Jadwigi Śląskiej', 'geoPoint': {'lat': 51.31076, 'lon': 17.06331}}], 'centralContacts': [{'name': 'Henryk Szymański MD PhD', 'role': 'CONTACT', 'email': 'henryk.t.szymanski@gmail.com', 'phone': '0048604467073'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Avaliable after the publication', 'ipdSharing': 'YES', 'description': 'The datasets used and/or generated during this study will be made available after the publication of results', 'accessCriteria': "Upon researcher's personal request"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Szpital im. Św. Jadwigi Śląskiej', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}