Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-10 @ 1:51 AM
Study NCT ID:
NCT02333669
Status:
COMPLETED
Last Update Posted:
2015-01-07
First Post:
2015-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-06', 'studyFirstSubmitDate': '2015-01-03', 'studyFirstSubmitQcDate': '2015-01-06', 'lastUpdatePostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genotype distributions of target SNPs in RDS group and Control group', 'timeFrame': 'within 28 days after birth', 'description': 'Compare the genotype and allele frequencies of target SNPs between RDS group and the control group'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung fluid absorption disorders', 'Neonatal respiratory distress syndrome', 'Single nucleotide polymorphism', 'SCNN1A'], 'conditions': ['Neonatal Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'Lung fluid absorption disorders are largely mediated by transepithelial Na+ reabsorption through alpha epithelial sodium channels (α-ENaCs) in alveolar epithelial cells. Increasing evidence has demonstrated that these lung disorders might be an important cause of neonatal respiratory distress syndrome (NRDS) by influencing gas exchange or surfactant function, particularly in near-term and term infants. The SCNN1A gene, which encodes the α-ENaC, might predispose infants to NRDS. To explore whether the single-nucleotide polymorphisms (SNPs) of SCNN1A are associated with NRDS, we conducted a case-control study to investigate the NRDS-associated loci in Han Chinese infants. Seven target SNPs were selected from the SCNN1A gene and were genotyped using the improved multiplex ligase detection reaction (iMLDR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Minute', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Newborns with RDS are consecutively recruited for this study from the neonatal intensive care unit (NICU) at Daping Hospital, Third Military Medical University, Chongqing, China, a tertiary care facility. The control blood samples, which are collected from healthy neonatal umbilical cord blood, are obtained from the maternity ward of 80 hospitals in Chongqing and nearby areas.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns with RDS\n\nExclusion Criteria:\n\n* The infants were excluded if they had any congenital malformation, inherited metabolic abnormalities, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia'}, 'identificationModule': {'nctId': 'NCT02333669', 'briefTitle': 'Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'DapingH023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'The control blood samples, which were collected from healthy neonatal umbilical cord blood, were obtained from the maternity ward of 80 hospitals in Chongqing and nearby areas', 'interventionNames': ['Other: no intervention']}, {'label': 'RDS group', 'description': 'Newborns with RDS were consecutively recruited for this study from the neonatal intensive care unit (NICU) at Daping Hospital, Third Military Medical University, Chongqing, China, a tertiary care facility', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Control group', 'RDS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Department of pediatrics, Daping Hospital, The Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Yuan Shi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'investigatorFullName': 'Li Wang', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}