Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-20 @ 6:37 PM
Study NCT ID:
NCT02358460
Status:
COMPLETED
Last Update Posted:
2015-02-09
First Post:
2015-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pressure-limited Ventilation Versus Volume-targeted Ventilation in Term Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, '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': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-03', 'studyFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2015-02-03', 'lastUpdatePostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of mechanical ventilation', 'timeFrame': 'For each patient, the exact number of hours from the date and time of randomisation to the date and time of successful removal of the endotracheal tube, assessed up to 4 weeks.', 'description': 'Data will be collected from the intensive care observation chart to determine the time at which the infant was successfully taken off of mechanical ventilation, assessed up to 4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neonatal', 'respiratory', 'mechanical ventilation'], 'conditions': ['Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': 'A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.', 'detailedDescription': 'Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. It is not known whether the same is true in the case of infants born at term. This study aims to compare pressure-limited to VTV in term-born infants.\n\nHypothesis: Volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated infants 34 weeks or more gestational age at birth were recruited and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV or peak pressures of more than 30 cm of water. Analysis will be by intention-to-treat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanically ventilated\n* Born at gestation 34 weeks and above\n\nExclusion Criteria:\n\n* Congenital diaphragmatic hernia\n* Congenital heart disease'}, 'identificationModule': {'nctId': 'NCT02358460', 'briefTitle': 'Pressure-limited Ventilation Versus Volume-targeted Ventilation in Term Newborns', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Randomised Controlled Trial Comparing Volume-targeted to Pressure-limited Ventilation in Infants Born at or Near Term', 'orgStudyIdInfo': {'id': '07/H0808/147-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pressure-limited ventilation', 'interventionNames': ['Device: Ventilation delivered by SLE5000 ventilator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Volume-targeted ventilation', 'interventionNames': ['Device: Ventilation delivered by SLE5000 ventilator']}], 'interventions': [{'name': 'Ventilation delivered by SLE5000 ventilator', 'type': 'DEVICE', 'description': 'In pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination.\n\nIn volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits.', 'armGroupLabels': ['Pressure-limited ventilation', 'Volume-targeted ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Neonatal Intensive Care Unit', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Anne Greenough, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}