Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 8:50 PM
Study NCT ID:
NCT05647850
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2022-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization and Clinical Study of Early Prediction Model for Neonatal Acute Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Umbilical cord blood was used to test inflammatory markers of Umbilical cord blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2022-11-30', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General characteristics of the patients', 'timeFrame': '2023.1-2025.12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonatal acute respiratory distress syndrome', 'Model of prediction', 'Perinatal factors'], 'conditions': ['Neonatology']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn about neonatal acute respiratory distress syndrome in describe participant population. The main question it aims to answer is: using perinatal factors to predict early neonatal acute respiratory distress syndrome and reduce its mortality.\n\nParticipants' umbilical cord blood will be collected for testing, but will not receive any intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All infants from a multi-center study in China, will hospitalise between January 1, 2023 and December 31, 2025.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A newborn born alive\n\nExclusion Criteria:\n\n* Stillborn newborn\n* Respiratory distress syndrome(RDS), transient tachypnoea of the neonate (TTN), or congenital anomalies as a primary current acute respiratory condition\n* Hereditary endocrine and metabolic diseases\n* Incomplete records'}, 'identificationModule': {'nctId': 'NCT05647850', 'briefTitle': 'Optimization and Clinical Study of Early Prediction Model for Neonatal Acute Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University-Town Hospital of Chongqing Medical University'}, 'officialTitle': 'Optimization and Clinical Study of Early Prediction Model for Neonatal Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': '123456'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Baseline characteristics of all patients', 'interventionNames': ['Other: No intervention']}, {'label': 'General characteristics of the patients.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Baseline characteristics of all patients', 'General characteristics of the patients.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuqing Tang', 'role': 'CONTACT'}], 'facility': 'University-Town Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Liu', 'role': 'CONTACT'}], 'facility': "Women and Children's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Hui Liu', 'role': 'CONTACT', 'email': 'liuhui8805@126.com', 'phone': '+8615223013501'}], 'overallOfficials': [{'name': 'Hui Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University-Town Hospital of Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University-Town Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Hui Liu', 'investigatorAffiliation': 'University-Town Hospital of Chongqing Medical University'}}}}