Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-01-16 @ 3:37 AM
Study NCT ID:
NCT04245202
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2020-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aykuteski1984@gmail.com', 'phone': '05303009760', 'title': 'Dr. Aykut Eşki', 'organization': 'Ege University Medical Faculty Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was performed in a single center and had a limited sample size. We did not blind the allocation of oxygen therapies to introduce the risk of performance bias.\n\nWe did not reach the number of participants calculated with the power analysis because of the financial support problem. Therefore, we used effect size for each of the primary outcomes.\n\nPatients were not allocated to receive therapy in a ratio of 1:1. Hence, a numerical difference occurred between the two groups.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for 6 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Comparator: High-Flow Nasal Cannula Oxygen Therapy', 'description': "Children in the high-flow group received heated and humidified high-flow oxygen at a rate of 2 L\\*kg/min (maximum 25 L/min), using an age-appropriate Optiflow Junior cannula and Airvo 2 high-flow system (Fisher and Paykel Healthcare). The initial fraction of inspired oxygen (FiO2) was set at 40%. The starting flow rate continued for a minimum of 4 hours. According to the patients' clinical response, the flow rate was decreased by 0.5 L\\*kg/min per hour. The FiO2 was adjusted to obtain the oxygen saturation levels between 92-98%. When the flow rate was at 0.5 L\\*kg/min, and the FiO2 was equal to the ambient oxygen concentration, High-Flow nasal cannula oxygen therapy was stopped.", 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 5, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Comparator: Standard Face Mask Oxygen Therapy', 'description': 'Children in the standard-therapy group received supplemental oxygen via a simple face mask, a range of 6-10 L/min, to maintain the oxygen saturation level between 92-98%. Those who sustained the oxygen saturation \\>92% in the ambient oxygen concentration were weaned off Standard Face Mask Oxygen Therapy.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 1, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Transient bradicardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '24'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 96 hours', 'description': 'The time that heart rate takes into the normal range for age between the groups (Per-protocol analysis).', 'unitOfMeasure': 'hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population of the per-protocol.'}, {'type': 'PRIMARY', 'title': 'Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '48'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '12'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 96 hours', 'description': 'The time that the respiratory rate takes into the normal range for age between the groups (Per-protocol analysis).', 'unitOfMeasure': 'hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population of the per-protocol.'}, {'type': 'PRIMARY', 'title': 'Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '24'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 96 hours', 'description': 'Unabbreviated scale title: Clinical Respiratory Score (Per-protocol analysis). The time that takes from severe bronchiolitis (9-12 points) to moderate bronchiolitis (5-8 points) or from moderate bronchiolitis (5-8 points) to mild bronchiolitis (0-4 points) between the groups. Higher scores mean a worse outcome. The score ranges from 0-12.', 'unitOfMeasure': 'hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population of the per-protocol.'}, {'type': 'SECONDARY', 'title': 'Heart Rate (Intention-to-treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '172.90', 'groupId': 'OG000', 'lowerLimit': '167.68', 'upperLimit': '178.64'}, {'value': '171.05', 'groupId': 'OG001', 'lowerLimit': '165.26', 'upperLimit': '176.84'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '166.21', 'groupId': 'OG000', 'lowerLimit': '160.99', 'upperLimit': '171.43'}, {'value': '151.28', 'groupId': 'OG001', 'lowerLimit': '145.49', 'upperLimit': '157.07'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '164.00', 'groupId': 'OG000', 'lowerLimit': '158.78', 'upperLimit': '169.22'}, {'value': '146.59', 'groupId': 'OG001', 'lowerLimit': '140.80', 'upperLimit': '152.38'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '159.65', 'groupId': 'OG000', 'lowerLimit': '154.43', 'upperLimit': '164.86'}, {'value': '138.05', 'groupId': 'OG001', 'lowerLimit': '132.26', 'upperLimit': '143.84'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '153.43', 'groupId': 'OG000', 'lowerLimit': '147.88', 'upperLimit': '158.98'}, {'value': '132.47', 'groupId': 'OG001', 'lowerLimit': '126.64', 'upperLimit': '138.29'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '142.96', 'groupId': 'OG000', 'lowerLimit': '137.25', 'upperLimit': '148.67'}, {'value': '132.56', 'groupId': 'OG001', 'lowerLimit': '126.71', 'upperLimit': '138.40'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '139.21', 'groupId': 'OG000', 'lowerLimit': '133.42', 'upperLimit': '145.00'}, {'value': '128.48', 'groupId': 'OG001', 'lowerLimit': '122.63', 'upperLimit': '134.34'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '135.99', 'groupId': 'OG000', 'lowerLimit': '130.09', 'upperLimit': '141.90'}, {'value': '124.96', 'groupId': 'OG001', 'lowerLimit': '118.92', 'upperLimit': '130.99'}]}]}, {'title': '96 hours', 'categories': [{'measurements': [{'value': '133.61', 'groupId': 'OG000', 'lowerLimit': '127.60', 'upperLimit': '139.62'}, {'value': '119.47', 'groupId': 'OG001', 'lowerLimit': '113.15', 'upperLimit': '125.80'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.29', 'ciLowerLimit': '-23.53', 'ciUpperLimit': '-1.05', 'pValueComment': 'The p-Value of the interaction between time and groups was given. In all analyses, p values \\<0·05 were considered being statistically significant.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.72', 'estimateComment': 'Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Any differences in the time any recorded changes in heart rate from randomization to the patients' discharge within the groups and between the groups (Intention-to-treat analysis).", 'unitOfMeasure': 'beats per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Heart Rate (Per-protocol Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '169.03', 'groupId': 'OG000', 'lowerLimit': '164.22', 'upperLimit': '173.83'}, {'value': '170.37', 'groupId': 'OG001', 'lowerLimit': '165.56', 'upperLimit': '175.17'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '160.76', 'groupId': 'OG000', 'lowerLimit': '155.96', 'upperLimit': '165.57'}, {'value': '150.37', 'groupId': 'OG001', 'lowerLimit': '145.56', 'upperLimit': '155.17'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '157.58', 'groupId': 'OG000', 'lowerLimit': '152.77', 'upperLimit': '162.38'}, {'value': '145.39', 'groupId': 'OG001', 'lowerLimit': '140.59', 'upperLimit': '150.20'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '150.66', 'groupId': 'OG000', 'lowerLimit': '145.85', 'upperLimit': '155.46'}, {'value': '136.42', 'groupId': 'OG001', 'lowerLimit': '131.62', 'upperLimit': '141.23'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '147.08', 'groupId': 'OG000', 'lowerLimit': '142.27', 'upperLimit': '151.88'}, {'value': '131.32', 'groupId': 'OG001', 'lowerLimit': '126.51', 'upperLimit': '136.54'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '138.45', 'groupId': 'OG000', 'lowerLimit': '133.64', 'upperLimit': '143.25'}, {'value': '131.74', 'groupId': 'OG001', 'lowerLimit': '126.93', 'upperLimit': '136.54'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '135.97', 'groupId': 'OG000', 'lowerLimit': '131.17', 'upperLimit': '140.78'}, {'value': '127.89', 'groupId': 'OG001', 'lowerLimit': '123.09', 'upperLimit': '132.70'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '136.43', 'groupId': 'OG000', 'lowerLimit': '131.54', 'upperLimit': '141.31'}, {'value': '124.57', 'groupId': 'OG001', 'lowerLimit': '119.60', 'upperLimit': '129.54'}]}]}, {'title': '96 hours', 'categories': [{'measurements': [{'value': '133.85', 'groupId': 'OG000', 'lowerLimit': '128.90', 'upperLimit': '138.81'}, {'value': '122.53', 'groupId': 'OG001', 'lowerLimit': '117.30', 'upperLimit': '127.76'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.66', 'ciLowerLimit': '-22.05', 'ciUpperLimit': '-3.28', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.77', 'estimateComment': 'Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)', 'groupDescription': 'The p-Value of the interaction between time and groups was given. In all analyses, p values \\<0·05 were considered being statistically significant.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Any differences in the time any recorded changes in heart rate from randomization to the patients' discharge within the groups and between the groups (Per-protocol analysis).", 'unitOfMeasure': 'beats per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate (Intention-to-treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '65.08', 'groupId': 'OG000', 'lowerLimit': '62.77', 'upperLimit': '67.39'}, {'value': '66.71', 'groupId': 'OG001', 'lowerLimit': '64.15', 'upperLimit': '69.27'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '60.20', 'groupId': 'OG000', 'lowerLimit': '57.89', 'upperLimit': '62.51'}, {'value': '56.84', 'groupId': 'OG001', 'lowerLimit': '54.28', 'upperLimit': '59.40'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '57.45', 'groupId': 'OG000', 'lowerLimit': '55.14', 'upperLimit': '59.76'}, {'value': '51.10', 'groupId': 'OG001', 'lowerLimit': '48.54', 'upperLimit': '53.66'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '55.54', 'groupId': 'OG000', 'lowerLimit': '53.23', 'upperLimit': '57.85'}, {'value': '46.56', 'groupId': 'OG001', 'lowerLimit': '44.00', 'upperLimit': '49.12'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '51.06', 'groupId': 'OG000', 'lowerLimit': '48.63', 'upperLimit': '53.48'}, {'value': '44.15', 'groupId': 'OG001', 'lowerLimit': '41.57', 'upperLimit': '46.72'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '46.54', 'groupId': 'OG000', 'lowerLimit': '44.05', 'upperLimit': '49.03'}, {'value': '40.82', 'groupId': 'OG001', 'lowerLimit': '38.24', 'upperLimit': '43.40'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '41.89', 'groupId': 'OG000', 'lowerLimit': '39.36', 'upperLimit': '44.42'}, {'value': '39.32', 'groupId': 'OG001', 'lowerLimit': '36.74', 'upperLimit': '41.91'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '39.24', 'groupId': 'OG000', 'lowerLimit': '36.65', 'upperLimit': '41.82'}, {'value': '36.70', 'groupId': 'OG001', 'lowerLimit': '34.07', 'upperLimit': '39.34'}]}]}, {'title': '96 hours', 'categories': [{'measurements': [{'value': '37.75', 'groupId': 'OG000', 'lowerLimit': '35.12', 'upperLimit': '40.38'}, {'value': '35.47', 'groupId': 'OG001', 'lowerLimit': '32.79', 'upperLimit': '38.22'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.91', 'ciLowerLimit': '-8.68', 'ciUpperLimit': '0.86', 'pValueComment': 'The p-Value of the interaction between time and groups was given. In all analysis, p values \\<0.05 were considered being statistically significant.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.43', 'estimateComment': 'Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Any differences in the time any recorded changes in respiratory rate from randomization to the patients' discharge within the groups and between the groups (Intention-to-treat analysis).", 'unitOfMeasure': 'Breaths per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis.'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate (Per-protocol Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '65.52', 'groupId': 'OG000', 'lowerLimit': '63.15', 'upperLimit': '67.89'}, {'value': '66.68', 'groupId': 'OG001', 'lowerLimit': '64.31', 'upperLimit': '69.05'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '59.50', 'groupId': 'OG000', 'lowerLimit': '57.12', 'upperLimit': '61.87'}, {'value': '56.60', 'groupId': 'OG001', 'lowerLimit': '54.23', 'upperLimit': '58.97'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '55.34', 'groupId': 'OG000', 'lowerLimit': '52.96', 'upperLimit': '57.71'}, {'value': '50.65', 'groupId': 'OG001', 'lowerLimit': '48.28', 'upperLimit': '53.03'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '51.81', 'groupId': 'OG000', 'lowerLimit': '49.44', 'upperLimit': '54.18'}, {'value': '46.00', 'groupId': 'OG001', 'lowerLimit': '43.62', 'upperLimit': '48.37'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '48.13', 'groupId': 'OG000', 'lowerLimit': '45.75', 'upperLimit': '50.50'}, {'value': '43.71', 'groupId': 'OG001', 'lowerLimit': '41.33', 'upperLimit': '46.08'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '44.23', 'groupId': 'OG000', 'lowerLimit': '41.86', 'upperLimit': '46.60'}, {'value': '40.47', 'groupId': 'OG001', 'lowerLimit': '38.10', 'upperLimit': '42.84'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '40.07', 'groupId': 'OG000', 'lowerLimit': '37.70', 'upperLimit': '42.45'}, {'value': '39.05', 'groupId': 'OG001', 'lowerLimit': '36.68', 'upperLimit': '41.42'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '37.82', 'groupId': 'OG000', 'lowerLimit': '35.42', 'upperLimit': '40.22'}, {'value': '36.51', 'groupId': 'OG001', 'lowerLimit': '34.09', 'upperLimit': '38.92'}]}]}, {'title': '96 hours', 'categories': [{'measurements': [{'value': '36.63', 'groupId': 'OG000', 'lowerLimit': '34.20', 'upperLimit': '39.06'}, {'value': '35.37', 'groupId': 'OG001', 'lowerLimit': '32.85', 'upperLimit': '37.89'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.41', 'ciLowerLimit': '-6.62', 'ciUpperLimit': '1.78', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.14', 'estimateComment': 'Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)', 'groupDescription': 'The p-Value of the interaction between time and groups was given. In all analysis, p values \\<0.05 were considered being statistically significant.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Any differences in the time any recorded changes in respiratory rate from randomization to the patients' discharge within the groups and between the groups (Per-protocol analysis).", 'unitOfMeasure': 'breaths per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis.'}, {'type': 'SECONDARY', 'title': 'Clinical Respiratory Score (Intention-to-treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '10.0'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '11.0'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '10.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '9.0'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '10.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '8.0'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '9.5'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '7.0'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '7.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '6.0'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '6.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '5.0'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '5.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': '96 hours', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative treatment effect difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.07', 'pValueComment': 'The p-Value of the interaction between time and groups was given. In all analysis, p values \\<0.05 were considered being statistically significant.', 'estimateComment': 'Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)', 'statisticalMethod': 'Brunner-Langer Method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Unabbreviated scale title: Clinical Respiratory Score (Intention-to-treat analysis) Any differences in the time any recorded changes in the clinical respiratory score from randomization to the patients' discharge within the groups and between the groups.\n\nThis clinical respiratory score includes respiratory rate, retraction, dyspnea/consciousness status, and wheezing.\n\nThe severity of parameters is scored 0 to 3 points, and the patients with a clinical respiratory score of 0-4 points were defined as mild, moderate (5-8 points), and severe (9-12 point) bronchiolitis. Higher scores mean a worse outcome. The score ranges from 0-12.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis.'}, {'type': 'SECONDARY', 'title': 'Clinical Respiratory Score (Per-protocol Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '10.2'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '11.0'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '9.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '9.0'}]}]}, {'title': '2 hours', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '8.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '8.0'}]}]}, {'title': '4 hours', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '8.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '6.2'}]}]}, {'title': '12 hours', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '7.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '6.0'}]}]}, {'title': '24 hours', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '6.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '5.0'}]}]}, {'title': '48 hours', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '5.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': '72 hours', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': '96 hours', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative treatment effect difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'pValueComment': 'The p-Value of the interaction between time and groups was given. In all analysis, p values \\<0.05 were considered being statistically significant.', 'estimateComment': 'Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)', 'statisticalMethod': 'Brunner-Langer Method', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Unabbreviated scale title: Clinical Respiratory Score (Per-protocol analysis). Any differences in the time any recorded changes in the clinical respiratory score from randomization to the patients' discharge within the groups and between the groups. This clinical respiratory score includes respiratory rate, retraction, dyspnea/consciousness status, and wheezing. The severity of parameters is scored 0 to 3 points, and the patients with a clinical respiratory score of 0-4 points were defined as mild, moderate (5-8 points), and severe (9-12 point) bronchiolitis. Higher scores mean a worse outcome. The score ranges from 0-12.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis.'}, {'type': 'SECONDARY', 'title': 'Oxygen Requirement (Intention-to-treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '45.7'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '30.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 168 hours', 'description': 'The total duration of oxygen therapy (Intention-to-treat analysis).', 'unitOfMeasure': 'hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Oxygen Requirement (Per-protocol Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '38.5'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '30.0'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 168 hours', 'description': 'The total duration of oxygen therapy (Per-protocol analysis).', 'unitOfMeasure': 'hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay (Intention-to-treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '7.7'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '7.0'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 168 hours', 'description': "The time from randomization to the patient's discharge (Intention-to-treat analysis).", 'unitOfMeasure': 'day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay (Per-protocol Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'through study completion, an average of 168 hours', 'description': "The time from randomization to the patient's discharge (Per-protocol analysis).", 'unitOfMeasure': 'day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis'}, {'type': 'SECONDARY', 'title': 'Treatment Failure at 4 Hours (Intention-to-treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'The number of treatment failures at 4 hours in each study arm (Intention-to-treat analysis).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population of the intention to treat.'}, {'type': 'SECONDARY', 'title': 'Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 168 hours', 'description': 'The number of participants admitted to the intensive care unit for invasive mechanical ventilation (Intention-to-treat analysis).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis.'}, {'type': 'SECONDARY', 'title': 'Adverse Events of Therapy (Intention-to-treat Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'St-FMOT', 'description': 'Children who received Standard Face Mask Oxygen Therapy'}, {'id': 'OG001', 'title': 'HFNCOT', 'description': 'Children who received High-Flow Nasal Cannula Oxygen Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 168 hours', 'description': 'The number of participants with any adverse events in therapy groups (Intention-to-treat analysis).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'St-FMOT', 'description': 'Children in the standard-therapy group received supplemental oxygen via a simple face mask, a range of 6-10 L/min, to maintain oxygen saturation level between 92-98%. Those who sustained the oxygen saturation \\>92% in the ambient oxygen concentration were weaned off Standard face mask oxygen therapy.'}, {'id': 'FG001', 'title': 'HFNCOT', 'description': "Children in the high-flow group received heated and humidified high-flow oxygen at a rate of 2 L\\*kg/min (maximum 25 L/min), using an age-appropriate Optiflow Junior cannula and Airvo 2 high-flow system (Fisher and Paykel Healthcare). The initial fraction of inspired oxygen (FiO2) was set at 40%. The starting flow rate continued for a minimum of 4 hours. According to the patients' clinical response, the flow rate was decreased by 0.5 L\\*kg/min per hour. The FiO2 was adjusted to obtain the oxygen saturation levels between 92-98%. When the flow rate was at 0.5 L\\*kg/min, and the FiO2 was equal to the ambient oxygen concentration, High-Flow nasal cannula oxygen therapy was stopped."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'After getting consent.', 'groupId': 'FG000', 'numSubjects': '48'}, {'comment': 'After getting consent', 'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'From March 14, 2017, through March 10, 2020, 5643 patients were presented to the emergency department and pediatric pulmonology unit of Ege University Medical Faculty. Four hundred seventy-two children were eligible for the study, with 134 missing opportunities to enroll, and 251 parents declined consent. We randomly assigned 87 children to Standard face mask oxygen therapy and High-Flow nasal cannula therapy.', 'preAssignmentDetails': 'No patients were excluded from the study after participant enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'St-FMOT', 'description': 'Children who received standard face mask oxygen treatment'}, {'id': 'BG001', 'title': 'HFNCOT', 'description': 'Children who received high flow nasal cannula oxygen treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'BG000', 'lowerLimit': '3.6', 'upperLimit': '11.0'}, {'value': '6.0', 'groupId': 'BG001', 'lowerLimit': '3.0', 'upperLimit': '12.0'}, {'value': '6.0', 'groupId': 'BG002', 'lowerLimit': '3.5', 'upperLimit': '11.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational age at birth', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Prematurity (< 37 weeks)', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Term infant (> 36 weeks)', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight at the admission (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'BG000', 'lowerLimit': '6.0', 'upperLimit': '9.5'}, {'value': '8.0', 'groupId': 'BG001', 'lowerLimit': '5.1', 'upperLimit': '10.0'}, {'value': '8.0', 'groupId': 'BG002', 'lowerLimit': '6.0', 'upperLimit': '9.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline heart rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '174.0', 'groupId': 'BG000', 'lowerLimit': '156.2', 'upperLimit': '186.5'}, {'value': '170.0', 'groupId': 'BG001', 'lowerLimit': '157.0', 'upperLimit': '188.0'}, {'value': '173.0', 'groupId': 'BG002', 'lowerLimit': '157.0', 'upperLimit': '188.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'beat per minute', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline respiratory rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.5', 'groupId': 'BG000', 'lowerLimit': '60.0', 'upperLimit': '70.0'}, {'value': '66.0', 'groupId': 'BG001', 'lowerLimit': '60.0', 'upperLimit': '72.0'}, {'value': '66.0', 'groupId': 'BG002', 'lowerLimit': '60.0', 'upperLimit': '70.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline Oxygen Saturation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'BG000', 'lowerLimit': '86.2', 'upperLimit': '89.0'}, {'value': '87.0', 'groupId': 'BG001', 'lowerLimit': '84.0', 'upperLimit': '88.0'}, {'value': '88.0', 'groupId': 'BG002', 'lowerLimit': '86.0', 'upperLimit': '88.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percentage of saturated oxygen', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline clinical respiratory score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'BG000', 'lowerLimit': '7.0', 'upperLimit': '10.2'}, {'value': '9.5', 'groupId': 'BG001', 'lowerLimit': '8.7', 'upperLimit': '11.0'}, {'value': '9.0', 'groupId': 'BG002', 'lowerLimit': '8.0', 'upperLimit': '11.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Unabbreviated scale title: Clinical Respiratory Score, categorizing as severe bronchiolitis (9-12 points), moderate bronchiolitis (5-8 points), and mild bronchiolitis (0-4 points). Higher scores mean a worse outcome. This score involves respiratory rate, retraction, dyspnea/consciousness status, and wheezing. Each variable ranges from 0 to 3 points.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Severity of clinical respiratory score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Moderate', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Unabbreviated scale title: Clinical Respiratory Score, categorizing as severe bronchiolitis (9-12 points), moderate bronchiolitis (5-8 points), and mild bronchiolitis (0-4 points). Higher scores mean a worse outcome. This score involves respiratory rate, retraction, dyspnea/consciousness status, and wheezing. Each variable ranges from 0 to 3 points.', 'unitOfMeasure': 'Participants'}, {'title': 'Season admitted', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Winter', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Autumn', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Spring', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Summer', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of detected virus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No virus', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '1 virus', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '2 viruses', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Virus detected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'title': 'RSV', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'HRV', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'FLUA', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'PIV3', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'HBoV', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'hMPV', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'hCoV', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'RSV+HRV', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'RSV+PIV2', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'RSV+PIV3', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'RSV+FLUA', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'RSV+hCOV', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'HBoV+hCOV', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'hMPV+hCOV', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'hCOV+hAV', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'RSV+HBoV', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'HRV+FLUA', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'HRV+HBoV', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'No virus', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline demographic characteristics of participants according to allocation (Intention-to-treat analysis)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-10', 'size': 724976, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-14T08:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-14', 'studyFirstSubmitDate': '2020-01-23', 'resultsFirstSubmitDate': '2020-05-08', 'studyFirstSubmitQcDate': '2020-01-25', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-14', 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)', 'timeFrame': 'through study completion, an average of 96 hours', 'description': 'The time that heart rate takes into the normal range for age between the groups (Per-protocol analysis).'}, {'measure': 'Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)', 'timeFrame': 'through study completion, an average of 96 hours', 'description': 'The time that the respiratory rate takes into the normal range for age between the groups (Per-protocol analysis).'}, {'measure': 'Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)', 'timeFrame': 'through study completion, an average of 96 hours', 'description': 'Unabbreviated scale title: Clinical Respiratory Score (Per-protocol analysis). The time that takes from severe bronchiolitis (9-12 points) to moderate bronchiolitis (5-8 points) or from moderate bronchiolitis (5-8 points) to mild bronchiolitis (0-4 points) between the groups. Higher scores mean a worse outcome. The score ranges from 0-12.'}], 'secondaryOutcomes': [{'measure': 'Heart Rate (Intention-to-treat Analysis)', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Any differences in the time any recorded changes in heart rate from randomization to the patients' discharge within the groups and between the groups (Intention-to-treat analysis)."}, {'measure': 'Heart Rate (Per-protocol Analysis)', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Any differences in the time any recorded changes in heart rate from randomization to the patients' discharge within the groups and between the groups (Per-protocol analysis)."}, {'measure': 'Respiratory Rate (Intention-to-treat Analysis)', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Any differences in the time any recorded changes in respiratory rate from randomization to the patients' discharge within the groups and between the groups (Intention-to-treat analysis)."}, {'measure': 'Respiratory Rate (Per-protocol Analysis)', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Any differences in the time any recorded changes in respiratory rate from randomization to the patients' discharge within the groups and between the groups (Per-protocol analysis)."}, {'measure': 'Clinical Respiratory Score (Intention-to-treat Analysis)', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Unabbreviated scale title: Clinical Respiratory Score (Intention-to-treat analysis) Any differences in the time any recorded changes in the clinical respiratory score from randomization to the patients' discharge within the groups and between the groups.\n\nThis clinical respiratory score includes respiratory rate, retraction, dyspnea/consciousness status, and wheezing.\n\nThe severity of parameters is scored 0 to 3 points, and the patients with a clinical respiratory score of 0-4 points were defined as mild, moderate (5-8 points), and severe (9-12 point) bronchiolitis. Higher scores mean a worse outcome. The score ranges from 0-12."}, {'measure': 'Clinical Respiratory Score (Per-protocol Analysis)', 'timeFrame': 'Baseline, 1,2,4,12,24,48,72 and 96 hours', 'description': "Unabbreviated scale title: Clinical Respiratory Score (Per-protocol analysis). Any differences in the time any recorded changes in the clinical respiratory score from randomization to the patients' discharge within the groups and between the groups. This clinical respiratory score includes respiratory rate, retraction, dyspnea/consciousness status, and wheezing. The severity of parameters is scored 0 to 3 points, and the patients with a clinical respiratory score of 0-4 points were defined as mild, moderate (5-8 points), and severe (9-12 point) bronchiolitis. Higher scores mean a worse outcome. The score ranges from 0-12."}, {'measure': 'Oxygen Requirement (Intention-to-treat Analysis)', 'timeFrame': 'through study completion, an average of 168 hours', 'description': 'The total duration of oxygen therapy (Intention-to-treat analysis).'}, {'measure': 'Oxygen Requirement (Per-protocol Analysis)', 'timeFrame': 'through study completion, an average of 168 hours', 'description': 'The total duration of oxygen therapy (Per-protocol analysis).'}, {'measure': 'Length of Hospital Stay (Intention-to-treat Analysis)', 'timeFrame': 'through study completion, an average of 168 hours', 'description': "The time from randomization to the patient's discharge (Intention-to-treat analysis)."}, {'measure': 'Length of Hospital Stay (Per-protocol Analysis)', 'timeFrame': 'through study completion, an average of 168 hours', 'description': "The time from randomization to the patient's discharge (Per-protocol analysis)."}, {'measure': 'Treatment Failure at 4 Hours (Intention-to-treat Analysis)', 'timeFrame': '4 hours', 'description': 'The number of treatment failures at 4 hours in each study arm (Intention-to-treat analysis).'}, {'measure': 'Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).', 'timeFrame': 'through study completion, an average of 168 hours', 'description': 'The number of participants admitted to the intensive care unit for invasive mechanical ventilation (Intention-to-treat analysis).'}, {'measure': 'Adverse Events of Therapy (Intention-to-treat Analysis)', 'timeFrame': 'through study completion, an average of 168 hours', 'description': 'The number of participants with any adverse events in therapy groups (Intention-to-treat analysis).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Bronchiolitis', 'High Flow Nasal Cannula', 'Standard Face Mask'], 'conditions': ['Acute Bronchiolitis']}, 'referencesModule': {'references': [{'pmid': '29562151', 'type': 'RESULT', 'citation': 'Franklin D, Babl FE, Schlapbach LJ, Oakley E, Craig S, Neutze J, Furyk J, Fraser JF, Jones M, Whitty JA, Dalziel SR, Schibler A. A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis. N Engl J Med. 2018 Mar 22;378(12):1121-1131. doi: 10.1056/NEJMoa1714855.'}, {'pmid': '26572729', 'type': 'RESULT', 'citation': 'Franklin D, Dalziel S, Schlapbach LJ, Babl FE, Oakley E, Craig SS, Furyk JS, Neutze J, Sinn K, Whitty JA, Gibbons K, Fraser J, Schibler A; PARIS and PREDICT. Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A Paediatric Acute Respiratory Intervention Study (PARIS). BMC Pediatr. 2015 Nov 14;15:183. doi: 10.1186/s12887-015-0501-x.'}, {'pmid': '28353318', 'type': 'RESULT', 'citation': 'Liu G, Fan C, Wu H. High-flow nasal cannula therapies for respiratory management in pediatric patients. Minerva Pediatr. 2018 Oct;70(5):488-492. doi: 10.23736/S0026-4946.17.04781-8. Epub 2017 Mar 27.'}, {'pmid': '24846750', 'type': 'RESULT', 'citation': "Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21."}, {'pmid': '23900520', 'type': 'RESULT', 'citation': 'Bressan S, Balzani M, Krauss B, Pettenazzo A, Zanconato S, Baraldi E. High-flow nasal cannula oxygen for bronchiolitis in a pediatric ward: a pilot study. Eur J Pediatr. 2013 Dec;172(12):1649-56. doi: 10.1007/s00431-013-2094-4. Epub 2013 Jul 31.'}, {'pmid': '30343318', 'type': 'RESULT', 'citation': 'Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.'}, {'pmid': '28903952', 'type': 'RESULT', 'citation': 'Mace AO, Gibbons J, Schultz A, Knight G, Martin AC. Humidified high-flow nasal cannula oxygen for bronchiolitis: should we go with the flow? Arch Dis Child. 2018 Mar;103(3):303. doi: 10.1136/archdischild-2017-313950. Epub 2017 Sep 13. No abstract available.'}, {'pmid': '24912486', 'type': 'RESULT', 'citation': 'Testa G, Iodice F, Ricci Z, Vitale V, De Razza F, Haiberger R, Iacoella C, Conti G, Cogo P. Comparative evaluation of high-flow nasal cannula and conventional oxygen therapy in paediatric cardiac surgical patients: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2014 Sep;19(3):456-61. doi: 10.1093/icvts/ivu171. Epub 2014 Jun 8.'}, {'pmid': '25593745', 'type': 'RESULT', 'citation': 'Milesi C, Boubal M, Jacquot A, Baleine J, Durand S, Odena MP, Cambonie G. High-flow nasal cannula: recommendations for daily practice in pediatrics. Ann Intensive Care. 2014 Sep 30;4:29. doi: 10.1186/s13613-014-0029-5. eCollection 2014.'}, {'pmid': '27062623', 'type': 'RESULT', 'citation': 'Schibler A, Franklin D. Respiratory support for children in the emergency department. J Paediatr Child Health. 2016 Feb;52(2):192-6. doi: 10.1111/jpc.13078.'}, {'pmid': '23809346', 'type': 'RESULT', 'citation': 'Da Dalt L, Bressan S, Martinolli F, Perilongo G, Baraldi E. Treatment of bronchiolitis: state of the art. Early Hum Dev. 2013 Jun;89 Suppl 1:S31-6. doi: 10.1016/S0378-3782(13)70011-2.'}, {'pmid': '24442856', 'type': 'RESULT', 'citation': 'Beggs S, Wong ZH, Kaul S, Ogden KJ, Walters JA. High-flow nasal cannula therapy for infants with bronchiolitis. Cochrane Database Syst Rev. 2014 Jan 20;2014(1):CD009609. doi: 10.1002/14651858.CD009609.pub2.'}, {'pmid': '35293153', 'type': 'DERIVED', 'citation': 'Eski A, Ozturk GK, Turan C, Ozgul S, Gulen F, Demir E. High-flow nasal cannula oxygen in children with bronchiolitis: A randomized controlled trial. Pediatr Pulmonol. 2022 Jun;57(6):1527-1534. doi: 10.1002/ppul.25893. Epub 2022 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to compare the efficacy of two different oxygenation methods on decrease respiratory rate, heart rate, and clinical respiratory score in children with moderate to severe bronchiolitis requiring oxygen therapy.\n\n1. Standard face mask oxygen therapy (St-FMOT)\n2. High-flow nasal cannula oxygen therapy (HFNCOT)', 'detailedDescription': 'Bronchiolitis is the most common cause of hospitalization for children under one year of age and, caused by respiratory viruses. Although several medications and interventions studied for bronchiolitis treatment, hydration and oxygenation are the main treatments. High-flow nasal cannula oxygen therapy (HFNCOT) has been widely used to provide respiratory support in children with acute respiratory diseases.\n\nPatients had earlier improvement with HFNCOT to decrease the respiratory rate and respiratory effort than patients with standard low-flow oxygen therapy (SOT).\n\nHFNCOT therapy reduced more effective in heart rate, respiratory effort, and length of supportive oxygen treatment (LOOT) compared with SOT. However, the length of hospital stay (LOS) and feeding ability had better consequences in patients with moderate and severe bronchiolitis treated with HFNCOT.\n\nAnother published study shows that in infants with acute bronchiolitis, which required oxygen therapy, there was no significant difference between therapy groups in terms of LOOT, LOS, and admission to the intensive care unit (ICU). HFNCOT was more efficient than SOT and reduced the rate of intubation/invasive ventilation in severe bronchiolitis management. Despite these beneficial effects of HFNCOT, it was not recommended by international guidelines yet. However, well designed, prospective randomized controlled trials are still needed to use this therapy in the wards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 1-24 months applied with moderate and severe bronchiolitis requiring supplemental oxygen were eligible for the study.\n* The severity of bronchiolitis was assessed according to the clinical respiratory score (CRS) of Liu et al. (5). The patients with CRS ≥5 were included.\n* Peripheral oxyhemoglobin saturation is \\< 92%.\n\nExclusion criteria:\n\n* Children admitted to the ICU for urgent invasive mechanical ventilation;\n* those who received standard oxygen therapy (SOT) or HFNCOT at other facilities before arrival;\n* those with an underlying medical condition (such as congenital heart disease, chronic lung disease, neuromuscular disease, metabolic disease, or immunocompromised);\n* those who had a craniofacial malformation, an upper airway obstruction, pneumothorax, or nasal trauma, and missing parental consent or a refused permission of the participant.'}, 'identificationModule': {'nctId': 'NCT04245202', 'briefTitle': 'Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Moderate and Severe Bronchiolitis; a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '17-TIP-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: HFNCOT', 'description': 'Set between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation \\>92%.', 'interventionNames': ['Device: HFNCOT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: St-FMOT', 'description': 'To obtain oxygen saturation \\>92%', 'interventionNames': ['Other: St-FMOT']}], 'interventions': [{'name': 'HFNCOT', 'type': 'DEVICE', 'description': 'The patient will receive a high flow nasal of humidified oxygen, set between 2 to 25 l/min. The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation \\>92%.', 'armGroupLabels': ['Active Comparator: HFNCOT']}, {'name': 'St-FMOT', 'type': 'OTHER', 'description': 'The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation \\>92%.', 'armGroupLabels': ['Active Comparator: St-FMOT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'state': 'Select A State', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Medical Faculty', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Aykut Eşki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University Medical Study'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Pediatric Pulmonology', 'investigatorFullName': 'Aykut Eşki', 'investigatorAffiliation': 'Ege University'}}}}