Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT05031650
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2021-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of invasive mechanical ventilation', 'timeFrame': 'First 72 hours after the intervention', 'description': 'Need for intubation and mechanical ventilation (MV) Need for intubation and mechanical ventilation (MV)'}, {'measure': 'Incidence of Surfactant therapy', 'timeFrame': 'First 72 hours after the intervention', 'description': 'Surfactant therapy requirement'}, {'measure': 'SpO2 at 5th minute', 'timeFrame': '5 minute after the delivery', 'description': 'The oxygen saturation of the blood at 5 th minute'}, {'measure': 'SpO2 at 10th minute', 'timeFrame': '5 minute after the delivery', 'description': 'The oxygen saturation of the blood at 10 th minute'}], 'secondaryOutcomes': [{'measure': 'Incidence of pneumothorax', 'timeFrame': 'First 24 hours after the intervention', 'description': 'Incidence of pneumothorax during intervention and within 24 hours'}, {'measure': 'Incidence ofIVH (Grade 3-4)', 'timeFrame': 'First 72 hours after the intervention', 'description': 'Intraventricular hemorrhage (IVH)'}, {'measure': 'Duration of ventilatory support (non-invasive)', 'timeFrame': 'During first hospitalisation ( an average of 10 weeks)', 'description': 'Duration of non-invasive MV (days)'}, {'measure': 'Duration of invasive ventilatory support', 'timeFrame': 'During first hospitalisation ( an average of 10 weeks)', 'description': 'Duration of invasive MV ( days)'}, {'measure': 'Duration of oxygen (O2)', 'timeFrame': 'During hospitalisation ( an average of 10 weeks)', 'description': 'Duration of O2 treatment (days)'}, {'measure': 'Incidence of Surfactant treatment', 'timeFrame': 'During hospitalisation (an average of 10 weeks)', 'description': 'Mean number of surfactant treatment'}, {'measure': 'Bronchopulmonary dysplasia (BPD)', 'timeFrame': 'At 36th postnatal week or discharge (an average of 10 weeks after intervention ) whichever came first', 'description': 'Incidence of BPD'}, {'measure': 'Mortality', 'timeFrame': 'through study completion (an average of 10 weeks)', 'description': 'Death or composite outcome death/BPD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasal CPAP', 'delivery room', 'open lung strategy', 'PEEP', 'Respiratory Distress Syndrome', 'Individualised ventilation'], 'conditions': ['Respiratory Distress Syndrome in Premature Infant', 'Non-invasive Ventilation', 'Lung Injury']}, 'referencesModule': {'references': [{'pmid': '41247385', 'type': 'DERIVED', 'citation': 'Duman N, Durukan Tosun M, Tuzun F, Egeli T, Bas AY, Pamukcu MM, Deliloglu B, Akyildiz C, Armagan C, Keskinoglu P, Demirel N, Ozkan H. Non-invasive open lung strategy in delivery room: randomized controlled trial (OpenCPAP-DR). Eur J Pediatr. 2025 Nov 17;184(12):766. doi: 10.1007/s00431-025-06613-8.'}]}, 'descriptionModule': {'briefSummary': 'The opening and aeration of the lung is critical for a successful transition from fetal to neonatal life. Early nasal CPAP in the delivery room in spontaneously breathing premature babies with a gestational age of 30 weeks or less is a standard treatment approach since it reduces the need for invasive mechanical ventilation and surfactant therapy. In respiratory distress syndrome (RDS) management, providing optimal lung volumes in the very early period from the beginning of delivery room approaches probably augments the expected lung protective effect. Although the benefits of CPAP support are well known, standart CPAP pressures recommended in the guidelines may not meet the needs of individual babies. Maintaining lung patency in the delivery room is the main mechanism of action of CPAP and the requirement may vary individually depending on lung physiology.\n\nIn this multicenter randomized controlled study, we aimed to compare the effects of CPAP therapy applied with a personalized open lung strategy (openCPAP), and standard CPAP therapy (standardCPAP) on oxygenation, respiratory support need and surfactant treatment requirement in preterm babies with RDS in the delivery room.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Minutes', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born before 30 completed weeks of gestation and received early nCPAP immediately after birth in delivery room\n\nExclusion Criteria:\n\n* Requirement of surfactant or endotracheal intubation or positive pressure ventilation before the completion of interventions\n* Major congenital anomaly\n* Transportation to another hospital'}, 'identificationModule': {'nctId': 'NCT05031650', 'acronym': 'OpenCPAP-DR', 'briefTitle': 'Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Can Open Lung Strategy During Non-Invasive Respiratory Support of Very Premature Infants in the Delivery Room Reduce Non-Invasive Ventilation Failure Compared With Standard Approach? A Randomised Controlled Multicentric Trial', 'orgStudyIdInfo': {'id': 'Dokuz Eylul Neonatology'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'openCPAP', 'description': 'Immediately after birth, early nCPAP will be started with a nasal mask with a T-piece resuscitator with 8 cm H2O pressure and 0.30 fiO2. The heart rate (HR) and preductal saturation (SpO2) will be evaluated every 30 seconds. Individually, the following steps will be done according to the situation:\n\n* If the HR \\> 120 / min and SpO2 not measured yet or be in the target range: The pressure will be continue as 8 cmH2O.\n* If the HR between 100-120 but SpO2 below the target range or not measured yet : First the pressure will be increased to 10 cm H2O; than fiO2 will be increased gradually if the patient will not respond to 10 cmH2O pressure. Pressure will be reduced to 8 cmH2O if the HR remains\\> 120 / min and oxygen requirement \\<0.30 for more than 60 seconds.', 'interventionNames': ['Procedure: openCPAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standardCPAP', 'description': 'Immediately after birth, early nCPAP will be started with a nasal mask with T-piece resuscitator at 6 cmH2O pressure and 0.30 fiO2. HR and preductal saturation will be evaluated every 30 seconds. The following steps will be performed according to the situation:\n\n* If the HR \\> 120 / min and SpO2 be in the target range or not measurable yet: The pressure will be continue as 6 cmH2O.\n* If the HR between 100-120 but SpO2 below the target range or not measured yet : The pressure will increased up to 8 cm H2O. FiO2 will be increased gradually if the patient will not respond to 8 cmH2O pressure. Pressure will be reduced to 6 cmH2O if the HR remains\\> 120 / min and oxygen requirement \\<0.30 for more than 60 seconds.', 'interventionNames': ['Procedure: standardCPAP']}], 'interventions': [{'name': 'openCPAP', 'type': 'PROCEDURE', 'description': 'Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure', 'armGroupLabels': ['openCPAP']}, {'name': 'standardCPAP', 'type': 'PROCEDURE', 'description': 'Randomized to : Standard level CPAP between 6-8 cmH2O pressure', 'armGroupLabels': ['standardCPAP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Etlik Zubeyde Hanım Maternity and Children Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '35340', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Hasan Ozkan, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dokuz Eylül University- Faculty of Medicine'}, {'name': 'Nuray Duman, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dokuz Eylül University- Faculty of Medicine'}, {'name': 'Funda Tuzun, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dokuz Eylül University- Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'collaborators': [{'name': "Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Funda Tuzun', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}