Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

Study Overview
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Brief Summary
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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.

Official Title
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Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network

Conditions
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Perinatal Mortality, Cause of Neonatal Death, Cause of Stilbirth

Intervention / Treatment
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* Other: Coordinator
* Other: Physician-assigned cause of death


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonatal death with 7-days or stillbirth Lives in study cluster Exclusion Criteria: Mother died Delivery in hospital setting

Ages Eligible for Study
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Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Coordinator (non-physician) | Other: Coordinator<br>* Coordinator (non-physician) assigned cause of death<br>|
| Placebo Comparator: 2<br>Physician | Other: Physician-assigned cause of death<br>* Physician (gold standard) cause of death<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel |  | 7-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The COD for stillbirth as assigned by the Community Coordinator compared to the COD for stillbirth as assigned by the Physician Panel |  | 7 days | 
| The agreement between mothers' and birth attendants' responses on selected items on the VA questionnaire (considering the mothers' response as the reference standard). |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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verbal autopsy, stillbirth, neonatal death