Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-06-08 @ 8:07 PM
Study NCT ID:
NCT01664832
Status:
UNKNOWN
Last Update Posted:
2013-06-27
First Post:
2012-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-06-26', 'studyFirstSubmitDate': '2012-08-02', 'studyFirstSubmitQcDate': '2012-08-09', 'lastUpdatePostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'phasic esophageal pressure deflection', 'timeFrame': '4 hours'}], 'secondaryOutcomes': [{'measure': 'Cerebral oxygen saturation', 'timeFrame': '4 hours'}, {'measure': 'Arterial oxygen saturation', 'timeFrame': '4 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Premature Infants', 'snychronized ventilation', 'non-invasive ventilation', 'RDS'], 'conditions': ['Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).\n\nAnother objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.', 'detailedDescription': 'In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.\n\nFurthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPreterm infants recovering from respiratory failure with the following criteria were eligible for this study.\n\n* Gestational age \\<32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.\n* Informed consent available.\n\nExclusion Criteria:\n\n• Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.'}, 'identificationModule': {'nctId': 'NCT01664832', 'acronym': 'N_SIMV', 'briefTitle': 'Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?', 'orgStudyIdInfo': {'id': 'ULMN_SIMV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-nIMV', 'description': 'nIMV synchronized using abdominal pressure capsule sensor device', 'interventionNames': ['Device: S-nIMV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'nIMV', 'description': 'non-synchronized nasal intermittent mandatory ventilation group', 'interventionNames': ['Device: S-nIMV']}], 'interventions': [{'name': 'S-nIMV', 'type': 'DEVICE', 'description': "Synchronization of nasal breaths to infant's own respiratory effort", 'armGroupLabels': ['S-nIMV', 'nIMV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89075', 'city': 'Ulm', 'state': 'Baden-Wüttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Helmut Hummler, Prof. Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital University of Ulm", 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'centralContacts': [{'name': 'Helmut Hummle, Prof. Dr.', 'role': 'CONTACT', 'email': 'helmut.hummler@uniklinik-ulm.de', 'phone': '0731-500-57168'}, {'name': 'Li Huang, Master', 'role': 'CONTACT', 'email': 'hhuangli@hotmail.com', 'phone': '015776891592'}], 'overallOfficials': [{'name': 'Hummler Helmut, Prof. Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Helmut Hummler', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Helmut Hummler', 'investigatorFullName': 'Prof. Dr. Helmut Hummler', 'investigatorAffiliation': 'University of Ulm'}}}}