Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 6:31 PM
Study NCT ID:
NCT04777760
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2021-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'C580477', 'term': 'Surfactant Dysfunction'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bronchopulmonary dysplasia(BPD)', 'timeFrame': "at 36 weeks' gestational age or before discharge from hospital", 'description': 'the preterm infants will be diagnosed with BPD'}, {'measure': 'death', 'timeFrame': "at 36 weeks' gestational age or before discharge from hospital", 'description': 'the preterm infants die'}, {'measure': 'BPD and/or death', 'timeFrame': "at 36 weeks' gestational age or before discharge from hospital", 'description': 'the preterm infants will be diagnosed with BPD and/or death'}, {'measure': 'the predictive powers of one dose of surfactant to diagnose NRDS', 'timeFrame': 'seven days after birth', 'description': 'the sensitivity and accuracy of one dose of surfactant to diagnose NRDS'}, {'measure': 'the predictive powers of two and more doses of surfactant to diagnose NARDS', 'timeFrame': 'seven days after birth', 'description': 'the sensitivity and accuracy of two and more doses of surfactant to diagnose NARDS'}], 'secondaryOutcomes': [{'measure': 'intraventricular hemorrhage(IVH)', 'timeFrame': "before discharge or 36 weeks' gestational age", 'description': 'the preterm infants will be diagnosed with IVH'}, {'measure': 'air leak', 'timeFrame': "at 36 weeks' gestational age or before discharge from hospital", 'description': 'the preterm infants will be diagnosed with air leak'}, {'measure': 'periventricular leukomalacia(PVL)', 'timeFrame': "at 36 weeks' gestational age or before discharge from hospital", 'description': 'the preterm infants will be diagnosed with PVL'}, {'measure': 'necrotizing enterocolitis(NEC)', 'timeFrame': "at 36 weeks' gestational age or before discharge from hospital", 'description': 'the preterm infants will be diagnosed with NEC'}, {'measure': 'patent ductus arteriosis(PDA)', 'timeFrame': "at 36 weeks' gestational age or before discharge from hospital", 'description': 'the preterm infants will be diagnosed with PDA'}, {'measure': 'late-onset sepsis(LOS)', 'timeFrame': "at 36 weeks' gestational age or before discharge from hospital", 'description': 'the preterm infants will be diagnosed with LOS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome', 'Preterm Birth', 'Acute Respiratory Distress Syndrome', 'Surfactant Dysfunction']}, 'descriptionModule': {'briefSummary': 'In preterm infants with neonatal respiratory distress syndrome (NRDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal mortality. Nowadays, PS is commonly used in newborn infants with respiratory distress, but the incidences of bronchopulmonary dysplasia(BPD) and/or death are inconsistent. The result indicates that not all preterm infants with respiratory distress can be beneficial from PS.\n\nIn 2017, the international neonatal ARDS (NARDS) collaborative group provides the first consensus definition for NARDS. And whether or not PS being beneficial for preterm infants with NARDS remains unknown.', 'detailedDescription': 'To date, PS is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that PS does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of BPD in term and late preterm infants with meconium aspiration syndrome(MAS). Therefore, a reasonable speculation is that preterm infants with NARDS do not benefit from one dose of PS. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as NRDS in the first three days after birth.\n\nAccording to the diagnostic criteria of NARDS, a key procedure for diagnosis of NARDS is to exclude the newborn infants with NRDS. But no detailed procedures are available to differentiate NRDS from NARDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'minimumAge': '1 Minute', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants diagnosed with NRDS or NARDS were eligible. The diagnosis of NARDS was according to the criteria established by Montreux conference in 2017.The diagnosis of NRDS was according to the criteria established by European Consensus Guideline for the management of NRDS in 2019', 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligibility requirements for neonates were as follows:\n\n* The gestational age is less than 37 weeks and admitted to neonatal intensive care unit(NICU) in 24 h after birth\n* The neonates will be diagnosed with NRDS or NARDS\n* The neonates will be at least administrated one dose of surfactant\n\nExclusion Criteria:\n\none of the following criteria will be needed\n\n* major congenital anomalies\n* chromosomal abnormalities\n* upper respiratory tract abnormalities'}, 'identificationModule': {'nctId': 'NCT04777760', 'briefTitle': 'Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)', 'orgStudyIdInfo': {'id': 'surfactant for NRDS and ARDS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'one dose of surfactant', 'description': 'the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant', 'interventionNames': ['Drug: one dose of surfactant replacement']}, {'label': 'two and more doses of surfactant', 'description': 'the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant', 'interventionNames': ['Drug: two and more doses of surfactant replacement']}], 'interventions': [{'name': 'one dose of surfactant replacement', 'type': 'DRUG', 'description': 'the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant', 'armGroupLabels': ['one dose of surfactant']}, {'name': 'two and more doses of surfactant replacement', 'type': 'DRUG', 'description': 'the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant', 'armGroupLabels': ['two and more doses of surfactant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Long, MD,PhD', 'role': 'CONTACT', 'email': 'neuroclong@126.com', 'phone': '+8613883559467'}], 'facility': 'Chen', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Chen Long, MD, PhD', 'role': 'CONTACT', 'email': 'neuroclong@126.com', 'phone': '+8613883559467'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'preliminary estimate in 2025', 'ipdSharing': 'YES', 'description': 'the data will be accessed after two years of study accomplishment'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'Chen Long,MD', 'investigatorAffiliation': "Children's Hospital of Chongqing Medical University"}}}}