Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT01156467
Status:
COMPLETED
Last Update Posted:
2013-06-11
First Post:
2010-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059725', 'term': 'Interactive Ventilatory Support'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-10', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The duration of mechanical ventilation', 'timeFrame': '1 hour - 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Complications associated to mechanical ventilation', 'timeFrame': '1 hour - 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neurally adjusted ventilatory assist NAVA', 'Premature infant', 'Edi-signal'], 'conditions': ['Ventilation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out, whether it is possible to improve the ventilatory care of premature infants by using Neurally adjusted ventilatory assist (NAVA).\n\nThe study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature infants more individually.', 'detailedDescription': 'Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications especially in premature infants with immature lungs.\n\nIn this study investigators will compare currently used ventilation methods to a new neurally adjusted ventilatory assist (NAVA). The aim is to find out, whether by using this new method it is possible to decrease the complications associated to ventilatory care and to shorten the need for mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children of postconceptional age from 28+0 to 36+6 weeks needing mechanical ventilation for at least 60 minutes\n\nExclusion Criteria:\n\n* severe birth asphyxia, malformations, chromosomal abnormality or other condition, which will decrease the length of life\n* condition which prevents the positioning of an oro-/nasogastric tube'}, 'identificationModule': {'nctId': 'NCT01156467', 'briefTitle': 'Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants', 'orgStudyIdInfo': {'id': 'EETTMK:26/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Infants randomised to this arm will receive a regular nasogastric tube, and the ventilatory care is given as routinely is done.', 'interventionNames': ['Device: Control group, ventilation with i-Servo or Stephanie']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NAVA', 'description': 'Infants randomised to this arm will receive and Edi-catheter as an oro-/nasogastric tube and the Edi-signal will be monitored and when possible NAVA-ventilation used.', 'interventionNames': ['Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)']}], 'interventions': [{'name': 'Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)', 'type': 'DEVICE', 'description': 'Treatment with Edi-catheter', 'armGroupLabels': ['NAVA']}, {'name': 'Control group, ventilation with i-Servo or Stephanie', 'type': 'DEVICE', 'description': 'Ventilatory support is given as routinely is done in the neonatal intensive care unit, with the ventilators available. Normal nasogastric tube is used.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90100', 'city': 'Oulu', 'state': 'North Ostrobothnia', 'country': 'Finland', 'facility': 'University hospital of Oulu', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Timo Saarela, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oulu University Hospital'}, {'name': 'Merja Ålander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulu University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Merja Ålander', 'investigatorAffiliation': 'University of Oulu'}}}}