Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT04391634
Status:
COMPLETED
Last Update Posted:
2020-05-21
First Post:
2020-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-19', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'StO2', 'timeFrame': '6 hours', 'description': 'Cerebral oxygenation measured using near-infrared spectroscopy \\[percent\\]'}, {'measure': 'Stroke volume', 'timeFrame': '6 hours', 'description': 'Stroke volume (SV) monitored with electrical cardiometry \\[ml\\]'}, {'measure': 'Cardiac output', 'timeFrame': '6 hours', 'description': 'Cardiac output (CO) monitored with electrical cardiometry \\[L/min\\]'}, {'measure': 'Stroke index', 'timeFrame': '6 hours', 'description': 'Stroke index (SI) monitored with electrical cardiometry \\[ml/m2\\]'}, {'measure': 'Cardiac index', 'timeFrame': '6 hours', 'description': 'Cardiac index (CI) monitored with electrical cardiometry \\[L/min/m2\\]'}, {'measure': 'Stroke volume variation (SVV)', 'timeFrame': '6 hours', 'description': 'Stroke volume variation (SVV) monitored with electrical cardiometry \\[percent\\]'}, {'measure': 'Index of contractility', 'timeFrame': '6 hours', 'description': 'Index of contractility (ICON) monitored with electrical cardiometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome, Newborn', 'Respiratory Failure', 'Premature Birth']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.', 'detailedDescription': "Prospective, cross-over trial enrolling neonates \\<28 weeks' gestation requiring MV. Patients were ventilated for 3 hours with pressure controlled assist-control (PC-AC) mode, followed by 3-hours of volume guarantee assist-control ventilation (VG-AC). Continuous monitoring was carried out using pulse oximetry (oxygen saturation - SpO2 and heart rate - HR), near-infrared spectroscopy (cerebral oxygenation - StO2) and electrical cardiometry (circulatory parameters)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '27 Weeks', 'minimumAge': '24 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* premature infants born \\<28 weeks of gestation\n* respiratory failure in the course of respiratory distress syndrome requiring mechanical ventilation\n* stable condition with pH (acidity of blood)\\> 7.2 and pCO2 (carbon dioxide partial pressure) \\<60 mmHg in the blood gas analysis\n* no identified genetic syndromes and serious congenital malformations\n\nExclusion Criteria:\n\n* lack of written consent of patients' parents"}, 'identificationModule': {'nctId': 'NCT04391634', 'briefTitle': 'Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Cerebral Oxygenation and Circulatory Parameters During Pressure Controlled vs. Volume Targeted Mechanical Ventilation in the Extremely Preterm Infants With Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': '388/16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mechanical ventilation', 'description': 'Preterm infants on mechanical ventilation', 'interventionNames': ['Other: volume guarantee', 'Other: pressure-controlled']}], 'interventions': [{'name': 'volume guarantee', 'type': 'OTHER', 'description': 'volume guarantee assist-control mechanical ventilation', 'armGroupLabels': ['Mechanical ventilation']}, {'name': 'pressure-controlled', 'type': 'OTHER', 'description': 'pressure-controlled assist-control mechanical ventilation', 'armGroupLabels': ['Mechanical ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60-535', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Department of Neonatology at Poznań University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Tomasz Szczapa, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Poznan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}