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| ID | Type | Description | Link |
|---|---|---|---|
| U01HD040636 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Coordinator (non-physician) |
|
| 2 | Placebo Comparator | Physician |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coordinator | Other | Coordinator (non-physician) assigned cause of death |
| |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marion Koso-Thomas, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Study Director |
| Cyril Engmann | UNC at CHapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Carlos University | Guatemala City | Guatemala | ||||
| Aga Khan University |
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| Label | URL |
|---|---|
| Global Network | View source |
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| ID | Term |
|---|---|
| D066087 | Perinatal Death |
| D050497 | Stillbirth |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
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| Physician-assigned cause of death |
| Other |
Physician (gold standard) cause of death |
|
| 7 days |
| Karachi |
| Pakistan |
| Kinshasa School of Public Health | Kinshasa | Republic of the Congo |
| University of Zambia | Lusaka | Zambia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005313 | Fetal Death |