Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-01-25 @ 2:38 AM
Study NCT ID:
NCT03235661
Status:
UNKNOWN
Last Update Posted:
2021-02-16
First Post:
2017-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'BiPAP and nCPAP are used as primary mode of ventilation in preterm twins infants with RDS'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-14', 'studyFirstSubmitDate': '2017-07-28', 'studyFirstSubmitQcDate': '2017-07-28', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intubation rate', 'timeFrame': 'within 7 days', 'description': 'the baby was intubated'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['nCPAP', 'BiPAP', 'Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -bi-level positive airway pressure(BiPAP) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome', 'detailedDescription': 'Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of bi-level positive airway pressure(BiPAP) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'minimumAge': '5 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Gestational age (GA) is from 26 to 37 weeks;\n* 2\\. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;\n* 3\\. Respiratory distress syndrome Silverman score \\>5;\n* 4\\. Informed parental consent has been obtained.\n\nExclusion Criteria:\n\n* 1\\. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;\n* 2\\. Major congenital malformations or complex congenital heart disease;\n* 3\\. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;\n* 4\\. Cardiopulmonary arrest needing prolonged resuscitation;\n* 5\\. transferred out of the neonatal intensive care unit without treatment.'}, 'identificationModule': {'nctId': 'NCT03235661', 'briefTitle': 'Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins Infants', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins:A Randomized Controlled Trials', 'orgStudyIdInfo': {'id': 'twins with BiPAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BiPAP', 'description': 'BiPAP as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome', 'interventionNames': ['Device: BiPAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nCPAP', 'description': 'nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome', 'interventionNames': ['Device: nCPAP']}], 'interventions': [{'name': 'BiPAP', 'type': 'DEVICE', 'description': 'BiPAP is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome', 'armGroupLabels': ['BiPAP']}, {'name': 'nCPAP', 'type': 'DEVICE', 'description': 'nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome', 'armGroupLabels': ['nCPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan Ma, physician', 'role': 'CONTACT', 'email': 'zoe330@163.com', 'phone': '18680887330'}], 'facility': 'Department of Pediatrics, Daping Hospital, Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Ma Juan, MD', 'role': 'CONTACT', 'email': '476679422@qq.com', 'phone': '13883559467', 'phoneExt': '86'}, {'name': 'Ma Juan, MD', 'role': 'CONTACT', 'email': '476679422@qq.com', 'phone': '1388.559467', 'phoneExt': '86'}], 'overallOfficials': [{'name': 'Shi Yuan, PhD,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ma Juan', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}