Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-29 @ 9:53 AM
Study NCT ID:
NCT03479450
Status:
UNKNOWN
Last Update Posted:
2021-02-17
First Post:
2018-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013501', 'term': 'Surface-Active Agents'}], 'ancestors': [{'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-14', 'studyFirstSubmitDate': '2018-03-18', 'studyFirstSubmitQcDate': '2018-03-24', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bronchopulmonary dysplasia(BPD)', 'timeFrame': "before discharge or 36 weeks' gestational age", 'description': 'the incidence of BPD in infants with neonatal neonatal RDS'}, {'measure': 'death', 'timeFrame': "before discharge or 36 weeks' gestational age", 'description': 'the incidence of BPD in infants with neonatal RDS'}], 'secondaryOutcomes': [{'measure': 'intraventriclular hemorrhage(IVH)', 'timeFrame': "before discharge or 36 weeks' gestational age", 'description': 'the incidence of IVH in infants with neonatal RDS'}, {'measure': 'necrotizing enterocolitis(NEC)', 'timeFrame': "before discharge or 36 weeks' gestational age", 'description': 'the incidence of NEC in infants with neonatal RDS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surfactant']}, 'descriptionModule': {'briefSummary': 'The traditional concept believes that the etiology of neonatal respiratory distress syndrome (RDS) is immature development of lung,especially the surfactant synthesis system,and RDS is still one of the major causes of mortality and morbidity in newborns, especially premature infants.In recent years, using pulmonary surfactant replacement therapy (PS treatment) in the treatment of respiratory distress syndrome (RDS) is a major breakthrough in neonatal medicine.Combined with clinical practice and experience,and through Meta analysis of related randomized controlled trials (RCTs),it confirms that natural surfactant treatment can reduce mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung emphysema),and the incidence of bronchopulmonary dysplasia (BPD) or 28-day-old mortality.For RDS in preterm infants whose gestation is \\<35 weeks ,surfactant replacement therapy is also more effective than in nearly term and full term infants.Therefore, in the analysis of cases of different gestational age groups,the investigators should focus on the study of premature infants cases.Due to less relevant research for using PS treatment to cure newborn RDS in high altitude area,this retrospective study conducts statistics and analysis of recently three-year cases in some hospital of high altitude area,to explore the treatment effect of the high altitude region and the impact of altitude on the treatment.', 'detailedDescription': 'in order to explore feasibility and efficacy for PS treatment of newborn RDS in high-altitude area ,and its efficacy at different altitudes, the investigators conduct a multi-center retrospective study of RDS cases in Qinghai and Tibet these two high-altitude area,and use RDS cases under the unique conditions to do statistics and analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '10 Minutes', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the preterm infants less than 37 weeks and diagnosed with NRDS were included in the study.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* the preterm infants less than 37 weeks were included in the study;diagnosed with NRDS\n\nExclusion Criteria:\n\n* parents' rejecting to join;major congenital abnormalities"}, 'identificationModule': {'nctId': 'NCT03479450', 'briefTitle': 'Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study', '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 at High Altitude Areas:a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'surfactant for NRDS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'surfactant', 'type': 'DRUG', 'description': 'surfactant is given when neonatal respiratory distress syndrome is diagnosed'}]}, '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': 'petshi530@vip.163.com', 'phone': '13508300283'}, {'name': 'Chen Long, PhD,MD', 'role': 'CONTACT', 'email': '476679422@qq.com', 'phone': '13883559467'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'the first people hospital of Tibet autonomous region', 'class': 'UNKNOWN'}, {'name': 'the second people hospital of Lasa', 'class': 'UNKNOWN'}, {'name': 'the first people hospital of Shigatse', 'class': 'UNKNOWN'}, {'name': 'the first people hospital of Lasa', 'class': 'UNKNOWN'}, {'name': 'the people hospital of Linzhi', 'class': 'UNKNOWN'}, {'name': 'the people hospital of Laqu', 'class': 'UNKNOWN'}], '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'}}}}