Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 10:04 PM
Study NCT ID:
NCT01215461
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2010-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Mortality in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 645}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2010-10-05', 'studyFirstSubmitQcDate': '2010-10-05', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care.', 'timeFrame': 'neonatal outcomes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neonatal mortality', 'Preterm birth', 'Low gestational age', 'VLBW'], 'conditions': ['Neonatal Mortality']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care. As a result, an improved neonatal mortality classification system may be defined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '44 Weeks', 'minimumAge': '22 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates for whom healthcare was provided.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates for whom healthcare was provided\n* Born alive\n* Neonate greater than or equal to 22 0/7 weeks estimated gestational age\n\nExclusion Criteria:\n\n* Stillborn\n* Fetal demise\n* Neonates less than or equal to 21 6/7 weeks estimated gestational age'}, 'identificationModule': {'nctId': 'NCT01215461', 'briefTitle': 'Factors Associated With Mortality in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Pediatrix'}, 'officialTitle': 'Evaluation of Factors Associated With Mortality in Neonates', 'orgStudyIdInfo': {'id': 'PDX-001-10'}}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pediatrix', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}