Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-31 @ 6:34 AM
Study NCT ID:
NCT04984057
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2021-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}, {'id': 'D004374', 'term': 'Ductus Arteriosus, Patent'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'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': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118445', 'term': 'acetylamino propylidene diphosphonic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2021-07-24', 'studyFirstSubmitQcDate': '2021-07-24', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the size of PDA', 'timeFrame': 'within 7 days after birth', 'description': 'the size of PDA is zero'}, {'measure': 'BPD and/or death', 'timeFrame': "at 36 week's gestational age", 'description': "the BPD and/or death is diagnosed when the included infants remain needing oxygen at 36 week's gestational age"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome, Newborn', 'Patent Ductus Arteriosus', 'Bronchopulmonary Dysplasia', 'Preterm']}, 'descriptionModule': {'briefSummary': 'In preterm infants with neonatal respiratory distress syndrome (RDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal incidences of bronchopulmonary dysplasia(BPD) and/or death. But not all preterm infants with RDS can be beneficial. Otherwise, the international neonatal acute RDS (NARDS) collaborative group provides the first consensus definition for NARDS in 2017. And whether or not PS being beneficial in preterm infants with NARDS remains unknown.', 'detailedDescription': 'To date, the optimal dose of PS is inconsistent, although the recommended dose of PS is given in the 2019 update guideline. PS is not recommended to adult and pediatric ARDS. Systematic review indicates that PS does not reduce the incidences of BPD and death in infants with meconium aspiration syndrome(MAS, a subtype of NARDS). A reasonable speculation is that preterm infants with NARDS do not benefit from PS. And the speculation can explain why not all preterm infants with RDS can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as RDS in the first three days after birth.\n\nMeantime, the dose of PS given to infants with NARDS remains unknown. the aim of the present study is to assess the optimal dose of PS. the control group: PS is given according to the European RDS management guideline in 2019 edition. The study group: PS is stopped when the pressure is equal between before patent ductus arteriosus(bPDA) and after PDA(aPDA). the primary outcomes are the closure rate of PDA within 7 days, the incidence of BPD and/or death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Hours', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* gestation age less than or equal to 32 weeks\n* PS is needed\n\nExclusion Criteria:\n\n* main congenital abnormalities\n* parents' refusal or quit"}, 'identificationModule': {'nctId': 'NCT04984057', 'briefTitle': 'Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome(RDS)', 'orgStudyIdInfo': {'id': 'Surfactant dose'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PS is stopped when the pressure is equal between bPDA and aPDA', 'description': 'PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound', 'interventionNames': ['Drug: PS is stopped when the pressure is equal between bPDA and aPDA.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PS is given according to the 2019 European RDS management guideline', 'description': 'PS is given according to the 2019 European RDS management guideline', 'interventionNames': ['Drug: PS is given according to the 2019 European RDS management guideline']}], 'interventions': [{'name': 'PS is stopped when the pressure is equal between bPDA and aPDA.', 'type': 'DRUG', 'description': 'PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound', 'armGroupLabels': ['PS is stopped when the pressure is equal between bPDA and aPDA']}, {'name': 'PS is given according to the 2019 European RDS management guideline', 'type': 'DRUG', 'description': 'PS is given according to the 2019 European RDS management guideline', 'armGroupLabels': ['PS is given according to the 2019 European RDS management guideline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Long, PhD,MD', 'role': 'CONTACT', 'email': 'neuroclong@126.com', 'phone': '13883559467', 'phoneExt': '86'}], 'facility': "Children's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Chen Long, PhD,MD', 'role': 'CONTACT', 'email': 'neuroclong@126.com', 'phone': '13883559467', 'phoneExt': '86'}]}, '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"}}}}