Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT06321133
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2024-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula Weaning in Acute Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-03-17', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalization time from randomization', 'timeFrame': 'One week', 'description': 'Time in hours from the randomization to the time the family leaves hospital.'}], 'secondaryOutcomes': [{'measure': 'Treatment failures', 'timeFrame': 'One week', 'description': 'Need to restart the high flow therapy'}, {'measure': 'Readmission rate', 'timeFrame': 'Seven days from discharge', 'description': 'Need for readmission'}, {'measure': 'Overall hospitalization time', 'timeFrame': 'One week', 'description': 'The overall time, which includes the time interval prior to randomization'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute bronchiolitis'], 'conditions': ['Acute Bronchiolitis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy.', 'detailedDescription': "Acute bronchiolitis is the most common cause of hospitalization among infants in Finland, with its primary etiology being the RS- virus. Acute bronchiolitis is defined in Finland as an infant's first respiratory distress before the age of 1. There is no effective pharmacological treatment for acute bronchiolitis. High-flow nasal cannula therapy has been shown in large randomized trials to reduce the risk of intensive care unit admission for children. High-flow nasal cannulas are typically used at a flow rate of 2 liters per kilogram per minute. Despite widespread use, there is insufficient evidence to determine whether high-flow therapy should be discontinued abruptly or gradually tapered. Observational studies indicate that the majority of units opt for abrupt discontinuation. Common criteria for discontinuation include weaning off supplemental oxygen and maintaining normal oxygenation on room air for 4-6 hours. Gradual weaning has been shown in observational studies to prolong hospitalization compared to immediate cessation of therapy. In a randomized controlled trial conducted in a pediatric intensive care unit, direct discontinuation shortened the duration of treatment by up to two days. However, there have been no previous randomized trials conducted on bronchiolitis patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '0 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosed acute bronchiolitis\n* High flow nasal cannula treatment has lasted for at least 12 hours\n* Measured saturation 95 or more with room air\n* High flow rate is maximum 2l/kg/min\n* The treating doctors considers the infant suitable to be without high flow\n\nExclusion Criteria:\n\n* Major congenital anomaly of lungs, hearts or diaphragm\n* Bacterial pneumonia\n* Parents do not give consent'}, 'identificationModule': {'nctId': 'NCT06321133', 'briefTitle': 'High Flow Nasal Cannula Weaning in Acute Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'High Flow Nasal Cannula Weaning in Acute Bronchiolitis - an Open-label Randomized Controlled Trials', 'orgStudyIdInfo': {'id': '5402589'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate ending', 'description': 'High flow is ended immediately', 'interventionNames': ['Other: High flow nasal cannula immediate ending']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weaning', 'description': 'High flow is ended by gradually reducing the flow rate', 'interventionNames': ['Other: High flow nasal cannula weaning']}], 'interventions': [{'name': 'High flow nasal cannula immediate ending', 'type': 'OTHER', 'description': 'High flow is immediately ended', 'armGroupLabels': ['Immediate ending']}, {'name': 'High flow nasal cannula weaning', 'type': 'OTHER', 'description': 'High flow is gradually weaned by reducing the flow rate', 'armGroupLabels': ['Weaning']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Joensuu', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Paula Widgren, MD, PhD', 'role': 'CONTACT', 'email': 'paula.widgren@siunsote.fi', 'phone': '0045813 330 8285'}], 'facility': 'Siun Sote', 'geoPoint': {'lat': 62.60118, 'lon': 29.76316}}, {'city': 'Jyväskylä', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Milla Pitkänen, MD', 'role': 'CONTACT', 'email': 'milla.pitkanen@hyvaks.fi', 'phone': '0035814 2691811'}], 'facility': 'Central Finland Hospital District', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'city': 'Kuopio', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Ilari Kuitunen, MD, PhD', 'role': 'CONTACT', 'email': 'ilari.kuitunen@uef.fi', 'phone': '+358447174910'}, {'name': 'Marjo Renko, Professor', 'role': 'CONTACT'}, {'name': 'Katri Backman, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Miika Arvonen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Mikkeli', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Nicole Weisshoff, MD', 'role': 'CONTACT', 'email': 'nicole.weisshoff@etelasavonha.fi', 'phone': '0035815 3511'}], 'facility': 'Mikkeli Central Hospital', 'geoPoint': {'lat': 61.68857, 'lon': 27.27227}}], 'centralContacts': [{'name': 'Ilari Kuitunen, MD, PhD', 'role': 'CONTACT', 'email': 'ilari.kuitunen@uef.fi', 'phone': '+358447174910'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central Finland Hospital District', 'class': 'OTHER'}, {'name': 'Mikkeli Central Hospital', 'class': 'OTHER'}, {'name': 'Siun sote', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ilari Kuitunen', 'investigatorAffiliation': 'Kuopio University Hospital'}}}}