Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT01624012
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2012-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2012-06-04', 'studyFirstSubmitQcDate': '2012-06-17', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of inspired oxygen supply', 'timeFrame': '30minutes- 3weeks', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Duration of noninvasive ventilation', 'timeFrame': '30 minutes - 3 weeks', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 3 weeks'}, {'measure': 'Fraction of inspired oxygen', 'timeFrame': '0, 1, 3 and 6hours, after which every 6 hours', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 3 weeks'}, {'measure': 'Blood gas analyses', 'timeFrame': '3 weeks', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.'}, {'measure': 'Duration of parenteral nutrition', 'timeFrame': '3 weeks', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NIV NAVA', 'non-invasive ventilation'], 'conditions': ['Respiratory Distress Syndrome (RDS) of Neonate']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is better in noninvasive ventilation of premature infants than currently used Nasal Continuous Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not.\n\nThe investigators study hypothesis is that with NIV NAVA the invasive ventilation is more synchronous with patient, which will lead to a decrease in need of inspired oxygen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postconceptional age 28+0 - 36+6\n* need of ncpap treatment and inspired oxygen for at least 60 minutes\n\nExclusion Criteria:\n\n* severe birth asphyxia, malformation or chromosomal abnormality, or other condition, which will decrease life expectancy\n* any condition which prevents insertion of naso/orogastric tube'}, 'identificationModule': {'nctId': 'NCT01624012', 'acronym': 'NIV NAVA', 'briefTitle': 'Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants', 'orgStudyIdInfo': {'id': 'EETTMK:23/2011'}}, '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': 'ncpap', 'description': 'Patients randomized to this arm will receive noninvasive ventilation with continuous nasal CPAP as routinely in neonatal intensive care unit.', 'interventionNames': ['Device: Nasal continuous positive airway pressure']}], 'interventions': [{'name': 'NIV NAVA', 'type': 'DEVICE', 'description': 'Non invasive ventilation with neurally adjusted ventilatory assist', 'armGroupLabels': ['NIV NAVA']}, {'name': 'Nasal continuous positive airway pressure', 'type': 'DEVICE', 'description': 'Noninvasive respiratory support with continuous positive airway pressure', 'armGroupLabels': ['ncpap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90230', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Merja Ålander', 'investigatorAffiliation': 'University of Oulu'}}}}