Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT04385134
Status:
UNKNOWN
Last Update Posted:
2020-05-12
First Post:
2020-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enterovirus Surveillance During the Perinatal Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-08', 'studyFirstSubmitDate': '2020-05-08', 'studyFirstSubmitQcDate': '2020-05-08', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of enterovirus', 'timeFrame': '42 days', 'description': 'Detection of the rate of enterovirus infection and identify the genotype of enterovirus.'}], 'secondaryOutcomes': [{'measure': 'Detection of antibodies of enterovirus', 'timeFrame': '42 days', 'description': 'Detection of IgG antibodies of enterovirus'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enterovirus Infection During Perinatal Period']}, 'descriptionModule': {'briefSummary': 'Neonates could be infected by non-polio enterovirus easily. Some of the neonates may develop fatal complications within one week. The objective of this study were as following: 1.To understand the composition and epidemiological characteristics of enterovirus infection in pregnant women in some areas of China; 2.To understand the transmission from mother to their neonates; 3.To understand the pathogenic spectrum composition, epidemiological characteristics and clinical characteristics of enterovirus infection in neonates; 4.To understand the genetic variation and changes of enteroviruses; 5.To establish a quality management system for maternal and neonatal enterovirus laboratory testing and monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Three population would be studied. 1. General parturient; 2. Puerpera with fever; 3, Febrile newborns.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. General parturient: on the first day of the third week of each month, all parturients and their newborns admitted to the hospital (day shift 8:00-18:00) within that day; 2. Puerpera with fever: all puerperas with fever (body temperature \\>=37.5 degree C) and their newborns were included in summer and autumn (from May); 3. Febrile newborns: those included in summer and autumn (from May) with the following clinical characteristics: fever \\>=37.5 degree C, lasting for more than one day. And sign the informed consent form with the consent of the guardian.\n\nExclusion Criteria:\n\n* 1\\. Pregnant women with urinary tract infection, chorioamnionitis and bacterial infection; 2. Puerpera with fever due to urinary tract infection, chorioamnionitis and bacterial infection; 3. Newborns infected with other pathogens.'}, 'identificationModule': {'nctId': 'NCT04385134', 'briefTitle': 'Enterovirus Surveillance During the Perinatal Period', 'organization': {'class': 'OTHER', 'fullName': 'Seventh Medical Center of PLA General Hospital'}, 'officialTitle': 'Establishment and Application of the National Surveillance Network for Enterovirus During the Perinatal Period', 'orgStudyIdInfo': {'id': "Bayichildren's-02"}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General parturient', 'description': 'Observe the enterovirus infection in general parturients and their neonates.', 'interventionNames': ['Other: No intervention']}, {'label': 'Puerpera with fever', 'description': 'Observe the enterovirus infection in puerpera with fever and their neonates.', 'interventionNames': ['Other: No intervention']}, {'label': 'Febrile newborns', 'description': 'Observe the enterovirus infection in neonates', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Febrile newborns', 'General parturient', 'Puerpera with fever']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100700', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Zhichun Feng, Prof', 'role': 'CONTACT', 'email': 'zhichunfeng81@163.com', 'phone': '+86(10) 66721786'}, {'name': 'Lu Zhuang, PhD', 'role': 'CONTACT', 'email': 'zhlu1986@163.com', 'phone': '+86(10) 66721667'}], 'facility': "Bayi Children's Hospital, Seventh Medical Center, PLA general hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhichun Feng, Prof', 'role': 'CONTACT', 'email': 'fengzhichun81@163.com', 'phone': '+86(10) 66721786'}, {'name': 'Lu Zhuang, PhD', 'role': 'CONTACT', 'email': 'zhlu1986@163.com', 'phone': '+86(10) 66721667'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Bayi Children's Hospital Affiliated to PLA Army General Hospital, China", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}