Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-04 @ 9:04 PM
Study NCT ID:
NCT03231735
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a randomized controlled trial with a 1:1 parallel allocation of infants to mid or standard frequency ventilation using stratified permuted block design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alive ventilator free days', 'timeFrame': 'Days 1-28 after birth', 'description': 'The number of days alive and ventilator-free'}], 'secondaryOutcomes': [{'measure': 'Alive at day 28 after birth', 'timeFrame': 'Day 28 after birth', 'description': 'Number of infants alive'}, {'measure': 'Ventilator free', 'timeFrame': 'Day 28 after birth', 'description': 'Number of infants ventilator free'}, {'measure': 'Bronchopulmonary dysplasia', 'timeFrame': "Measured at 36 weeks' postmenstrual age", 'description': "Bronchopulmonary dysplasia in preterm infants less than 32 weeks' gestation"}, {'measure': 'Bronchopulmonary dysplasia', 'timeFrame': "Measured at 36 weeks' postmenstrual age", 'description': "Bronchopulmonary dysplasia in preterm infants less than 29 weeks' gestation"}, {'measure': 'Air leak syndrome', 'timeFrame': 'Day 1-28 after birth', 'description': 'Rate of pulmonary interstitial emphysema and/or pneumothorax'}, {'measure': 'Pulmonary hemorrhage', 'timeFrame': 'Day 1-28 after birth', 'description': 'Rate of pulmonary hemorrhage'}, {'measure': 'Severe (grade 3-4) intracranial hemorrhage', 'timeFrame': 'Day 1-30 after birth', 'description': "Rate of severe (grade 3-4) intracranial hemorrhage in infants less than 29 weeks' gestation"}, {'measure': 'Alive and continuous positive airway pressure/ventilator free', 'timeFrame': 'Day 1-28 after birth', 'description': 'Number of days alive and ontinuous positive airway pressure/ventilator free'}, {'measure': 'Alive and oxygen free', 'timeFrame': 'Day 1-28 after birth', 'description': 'Number of days alive and oxygen free'}, {'measure': 'Postnatal steroids', 'timeFrame': "Before 36 weeks' postmenstrual age", 'description': 'Rate of post natal steroids for bronchopulmonary dysplasia'}, {'measure': 'Necrotizing enterocolitis', 'timeFrame': 'Days 1-120 after birth', 'description': "Rate of proven necrotizing enterocolitis (NEC) in infants less than 29 weeks' gestation"}, {'measure': 'Neurodevelopmental impairment', 'timeFrame': '18 to 24 months after birth', 'description': "Rate of moderate to severe neurodevelopmental impairment in survivors \\< 27 weeks' gestation"}, {'measure': 'Bronchopulmonary dysplasia or death', 'timeFrame': 'Day 1-120 after birth', 'description': 'Rate of Bronchopulmonary dysplasia or death'}, {'measure': 'Neurodevelopmental impairment or death', 'timeFrame': 'Day 1-120 after birth', 'description': 'Rate of Bronchopulmonary dysplasia or death'}, {'measure': 'Bronchopulmonary dysplasia or death', 'timeFrame': '18 to 24 months after birth', 'description': 'Rate of moderate to severe neurodevelopmental impairment or death'}, {'measure': 'Necrotizing enterocolitis or death', 'timeFrame': 'Day 1-120 after birth', 'description': 'Rate of proven necrotizing enterocolitis or death'}, {'measure': 'Death', 'timeFrame': 'Day 1-120 after birth', 'description': 'Death before hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilator-Induced Lung Injury', 'Respiratory Distress Syndrome', 'Bronchopulmonary Dysplasia', 'Preterm Infant']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine, in preterm infants less than 37 weeks gestation with respiratory distress who are ventilated in the first 48 hours after birth, if mid frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared with standard frequency ventilation strategy using ventilator rates of ≥ 20 to \\< 60 per minute will increase the number of alive ventilator-free days after randomization and reduce the risk of ventilator induced lung injury.', 'detailedDescription': 'In preterm infants with respiratory distress syndrome (RDS) who are ventilated in the first 48 hours after birth, mid frequency ventilation (MFV) strategy, compared with standard frequency ventilation (SFV) strategy, in the first week after birth, will increase the number of days alive and ventilator-free in the 28 days after birth.\n\nThis will be a randomized controlled trial with a 1:1 parallel allocation of infants to MFV or SFV using stratified permuted block design. Randomization will be stratified by gestational age (≥ 23 weeks to ˂ 26 weeks, ≥ 26 weeks to ≤ 28+6/7 (less than 29 weeks), and 29+0/7 to 36+6/7). Randomization of twins and higher orders (when eligible) will be to the same group.\n\nInborn and outborn infants who are receiving assisted ventilation for RDS in the first 48 hours after birth will be included in this study. Infants with any of the following: a major malformation, a neuromuscular condition that affects respiration, terminal illness or decision to withhold or limit support will not be eligible.\n\nInfants will be randomized to MFV versus SFV. MFV delivered at rates \\> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.\n\nSFV delivered at rates \\< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants ≥ 23+0/7 weeks and ≤ 36+6/7 who are intubated and mechanically ventilated for respiratory distress syndrome (defined by use of surfactant) within 48 hours after birth\n* Infants whose parents/legal guardians have provided consent for enrollment\n* Inborn or outborn infants transferred to this center before 48 hours after birth\n* Ventilator rate ≤ 80 per minute prior to enrollment\n\nExclusion Criteria:\n\n* a major malformation, a neuromuscular condition that affects respiration, or terminal illness or decision to withhold or limit support.'}, 'identificationModule': {'nctId': 'NCT03231735', 'acronym': 'MIDAS', 'briefTitle': 'Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Randomized Controlled Trial of Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'F160701002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mid frequency ventilation', 'description': 'Mid frequency ventilation delivered at rates \\> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.', 'interventionNames': ['Device: Mid frequency ventilation']}, {'type': 'OTHER', 'label': 'Standard frequency ventilation', 'description': 'Standard frequency ventilation delivered at rates \\< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.', 'interventionNames': ['Device: Standard frequency ventilation']}], 'interventions': [{'name': 'Mid frequency ventilation', 'type': 'DEVICE', 'description': 'Mechanical ventilator used at rates \\> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.', 'armGroupLabels': ['Mid frequency ventilation']}, {'name': 'Standard frequency ventilation', 'type': 'DEVICE', 'description': 'Mechanical ventilator used at rates \\< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.', 'armGroupLabels': ['Standard frequency ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}], 'overallOfficials': [{'name': 'Waldemar A Carlo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of South Alabama', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Colm Travers', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}