Verbal Autopsy to Assess Early Neonatal Death and Stillbirth (VA)
Primary Purpose
Perinatal Mortality, Cause of Neonatal Death, Cause of Stilbirth
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Coordinator
Physician-assigned cause of death
Sponsored by
About this trial
This is an interventional diagnostic trial for Perinatal Mortality focused on measuring verbal autopsy, stillbirth, neonatal death
Eligibility Criteria
Inclusion Criteria:
- Neonatal death with 7-days or stillbirth
- Lives in study cluster
Exclusion Criteria:
- Mother died
- Delivery in hospital setting
Sites / Locations
- Kinshasa School of Public Health
- San Carlos University
- Aga Khan University
- University of Zambia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Coordinator (non-physician)
Physician
Outcomes
Primary Outcome Measures
Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel
Secondary Outcome Measures
The COD for stillbirth as assigned by the Community Coordinator compared to the COD for stillbirth as assigned by the Physician Panel
The agreement between mothers' and birth attendants' responses on selected items on the VA questionnaire (considering the mothers' response as the reference standard).
Full Information
NCT ID
NCT00640055
First Posted
March 18, 2008
Last Updated
July 29, 2014
Sponsor
NICHD Global Network for Women's and Children's Health
1. Study Identification
Unique Protocol Identification Number
NCT00640055
Brief Title
Verbal Autopsy to Assess Early Neonatal Death and Stillbirth
Acronym
VA
Official Title
Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NICHD Global Network for Women's and Children's Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The NICHD Global Network (GN) for Women's and Children's Health Research, a multi-site, international research network, provides a unique infrastructure to implement an expanded perinatal verbal autopsy study using the FIRST BREATH trial as its platform. The FIRST BREATH trial is an ongoing study of neonatal resuscitation training in rural community settings within Global Network sites in Central Africa, Asia and Latin America.
This study uses a validated VA questionnaire to determine COD of stillbirths and early neonatal deaths among participants in the FIRST BREATH study. We propose to expand the usefulness of perinatal verbal autopsy methodology in two ways. First by assessing whether the Community Coordinator (a non-physician health worker) can assign COD with a high level of concordance comparable to a Physician Panel, and second, whether the FIRST BREATH Birth Attendant can provide as reliable perinatal information as the mother during the VA interview. Our primary hypothesis is that the COD assigned by the FIRST BREATH Community Coordinator will be the same as the COD assigned by the Physician Panel in greater than 70% of early neonatal deaths (ENDs), when both use the same VA and FIRST BREATH data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Mortality, Cause of Neonatal Death, Cause of Stilbirth
Keywords
verbal autopsy, stillbirth, neonatal death
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Coordinator (non-physician)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Physician
Intervention Type
Other
Intervention Name(s)
Coordinator
Intervention Description
Coordinator (non-physician) assigned cause of death
Intervention Type
Other
Intervention Name(s)
Physician-assigned cause of death
Intervention Description
Physician (gold standard) cause of death
Primary Outcome Measure Information:
Title
Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel
Time Frame
7-days
Secondary Outcome Measure Information:
Title
The COD for stillbirth as assigned by the Community Coordinator compared to the COD for stillbirth as assigned by the Physician Panel
Time Frame
7 days
Title
The agreement between mothers' and birth attendants' responses on selected items on the VA questionnaire (considering the mothers' response as the reference standard).
Time Frame
7 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Neonatal death with 7-days or stillbirth
Lives in study cluster
Exclusion Criteria:
Mother died
Delivery in hospital setting
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Koso-Thomas, MD
Organizational Affiliation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cyril Engmann
Organizational Affiliation
UNC at CHapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinshasa School of Public Health
City
Kinshasa
Country
Congo
Facility Name
San Carlos University
City
Guatemala City
Country
Guatemala
Facility Name
Aga Khan University
City
Karachi
Country
Pakistan
Facility Name
University of Zambia
City
Lusaka
Country
Zambia
12. IPD Sharing Statement
Links:
URL
http://gn.rti.org
Description
Global Network
Learn more about this trial
Verbal Autopsy to Assess Early Neonatal Death and Stillbirth
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