Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00518856
Status:
COMPLETED
Last Update Posted:
2011-03-31
First Post:
2007-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lufwanyama Neonatal Survival Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Zambia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001238', 'term': 'Asphyxia Neonatorum'}, {'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3559}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-29', 'studyFirstSubmitDate': '2007-08-20', 'studyFirstSubmitQcDate': '2007-08-20', 'lastUpdatePostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'day 28'}], 'secondaryOutcomes': [{'measure': 'perinatal mortality', 'timeFrame': 'day zero'}, {'measure': 'sepsis mortality', 'timeFrame': 'deaths between days 1-28'}, {'measure': 'cost effectiveness', 'timeFrame': 'days 0-28'}, {'measure': 'successful delivery of nevirapine prophylaxis to HIV exposed deliveries', 'timeFrame': 'day zero umbilical cord dried blood spot'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['birth asphyxia', 'neonatal sepsis', 'maternal to child transmission of HIV'], 'conditions': ['Mortality']}, 'referencesModule': {'references': [{'pmid': '22542215', 'type': 'DERIVED', 'citation': 'Gill CJ, Guerina NG, Mulenga C, Knapp AB, Mazala G, Hamer DH. Training Zambian traditional birth attendants to reduce neonatal mortality in the Lufwanyama Neonatal Survival Project (LUNESP). Int J Gynaecol Obstet. 2012 Jul;118(1):77-82. doi: 10.1016/j.ijgo.2012.02.012. Epub 2012 Apr 27.'}, {'pmid': '21292711', 'type': 'DERIVED', 'citation': 'Gill CJ, Phiri-Mazala G, Guerina NG, Kasimba J, Mulenga C, MacLeod WB, Waitolo N, Knapp AB, Mirochnick M, Mazimba A, Fox MP, Sabin L, Seidenberg P, Simon JL, Hamer DH. Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study. BMJ. 2011 Feb 3;342:d346. doi: 10.1136/bmj.d346.'}]}, 'descriptionModule': {'briefSummary': 'We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.', 'detailedDescription': 'This is a cluster randomized trial of the impact of providing additional training and supplies to traditional birth attendants in a rural setting in Zambia. 120 TBAs are randomized into intervention/control. Intervention TBAs receive NRP training, supplies for neonatal resuscitation, receiving blankets for thermoregulation, and amoxicillin tablets. Control TBAs continue according to prior standard of care. Primary outcome is mortality at 28 days life as a proportion of births attended by TBAs in each study arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TBA trained in safe delivery;\n* willing to sign informed consent; willing to be randomized; willing to adhere to study procedures\n\nExclusion Criteria:\n\n* TBA living outside of Lufwanyama district'}, 'identificationModule': {'nctId': 'NCT00518856', 'acronym': 'LUNESP', 'briefTitle': 'Lufwanyama Neonatal Survival Project', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Lufwanyama Neonatal Survival Project', 'orgStudyIdInfo': {'id': 'GHS-A-00-03-00020-00-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'TBAs who receive training and supplies for the intervention', 'interventionNames': ['Other: Neonatal resuscitation protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'TBAs continuing with current standard of practice', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'Neonatal resuscitation protocol', 'type': 'OTHER', 'description': 'training in neonatal resuscitation and sepsis identification early treatment', 'armGroupLabels': ['intervention']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'continued with current standard of care for birth attendants', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christopher J Gill, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Universtiy'}, {'name': 'Grace Mazala, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lufwanyama District Health Management Team'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tufts University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Davidson H. Hamer', 'oldOrganization': 'Boston University School of Public Health'}}}}