Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-01-04 @ 4:20 PM
Study NCT ID:
NCT02590757
Status:
COMPLETED
Last Update Posted:
2021-12-07
First Post:
2015-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-05', 'studyFirstSubmitDate': '2015-10-25', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extubation failure', 'timeFrame': 'extubation - 72 hours', 'description': 'Failure criteria\n\n* pH \\< 7.2 with pCO2 \\> 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings\n* Severe apnea event requiring bag and mask resuscitation\n* FiO2 \\>0.6 to maintain SpO2 ≥ 88% after extubation\n* Frequent desaturations (\\< 85%) ≥ 3/hr not responding to increased ventilatory settings or an increase in Fio2 to 1.0'}], 'secondaryOutcomes': [{'measure': 'FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation', 'timeFrame': 'extubation - 72 hours', 'description': 'Participants will be followed for the extubation failure within 3 days after extubation'}, {'measure': 'Severe apnea event requiring bag and mask resuscitation', 'timeFrame': 'extubation - 72 hours', 'description': 'Participants will be followed for the extubation failure within 3 days after extubation'}, {'measure': 'FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation', 'timeFrame': 'extubation - 7 days', 'description': 'Participants will be followed for the extubation failure within 7 days after extubation'}, {'measure': 'pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings', 'timeFrame': 'extubation - 7 days', 'description': 'Participants will be followed for the extubation failure within 7 days after extubation'}, {'measure': 'Severe apnea event requiring bag and mask resuscitation', 'timeFrame': 'extubation - 7 days', 'description': 'Participants will be followed for the extubation failure within 7 days after extubation'}, {'measure': 'Bronchopulmonary dysplasia', 'timeFrame': 'postmenstrual age 36 weeks', 'description': 'Participants will be followed for the duration of hospital stay'}, {'measure': 'Duration of noninvasive ventilation', 'timeFrame': 'postmenstrual age 40 weeks (until discharge)', 'description': 'Participants will be followed for the duration of hospital stay'}, {'measure': 'Duration of inspired oxygen supply', 'timeFrame': 'postmenstrual age 40 weeks (until discharge)', 'description': 'Participants will be followed for the duration of hospital stay'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'postmenstrual age 40 weeks (until discharge)', 'description': 'Participants will be followed for the duration of hospital stay'}, {'measure': 'Adverse events', 'timeFrame': 'extubation - 3days', 'description': 'Participants will be followed for 3 days after extubation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['non-invasive ventilation', 'non-invasive neurally adjusted ventilatory assist', 'nasal continuous positive airway pressure'], 'conditions': ['Endotracheal Extubation', 'Infant, Premature']}, 'referencesModule': {'references': [{'pmid': '35460702', 'type': 'DERIVED', 'citation': 'Shin SH, Shin SH, Kim SH, Song IG, Jung YH, Kim EK, Kim HS. Noninvasive Neurally Adjusted Ventilation in Postextubation Stabilization of Preterm Infants: A Randomized Controlled Study. J Pediatr. 2022 Aug;247:53-59.e1. doi: 10.1016/j.jpeds.2022.04.025. Epub 2022 Apr 20.'}]}, 'descriptionModule': {'briefSummary': "This study is a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' \\< 30 weeks of gestation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Weeks', 'minimumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postconceptional age less than 30+0 weeks\n* infants who fulfill the the criteria for extubation for 6 hours extubation criteria: Ventilator rate ≤ 25 breaths/min, Peak inspiratory pressure (PIP) ≤ 16cmH2O, Fractional inspired oxygen (FiO2) ≤ 0.3\n\nExclusion Criteria:\n\n* conditions which will decrease life expectancy\n* major anomalies which will decrease life expectancy\n* any anomalous conditions which involve upper and lower airway\n* neuromuscular disease'}, 'identificationModule': {'nctId': 'NCT02590757', 'briefTitle': 'Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': "Comparison of Non-invasive Ventilation Neurally Adjusted Ventilatory Assist vs. Nasal Continuous Positive Airway Pressure After Extubation in Infants' < 30 Weeks of Gestation: Randomized Controlled Study", 'orgStudyIdInfo': {'id': '2015-1917'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NIV-NAVA', 'description': 'Noninvasive ventilation in this group is practiced with NIV-NAVA', 'interventionNames': ['Device: NIV-NAVA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'N-CPAP', 'description': 'Patients in this group will receive nasal continuous positive airway pressure as routinely in neonatal intensive care unit.', 'interventionNames': ['Device: N-CPAP']}], 'interventions': [{'name': 'NIV-NAVA', 'type': 'DEVICE', 'description': 'Non-invasive neurally adjusted ventilatory assist', 'armGroupLabels': ['NIV-NAVA']}, {'name': 'N-CPAP', 'type': 'DEVICE', 'description': 'Nasal-continuous positive airway pressure', 'armGroupLabels': ['N-CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul National University Children's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Han-Suk Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director of Neonatal Intensive Care Unit', 'investigatorFullName': 'Han-Suk Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}