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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
200
Coordinator (non-physician) assigned cause of death
Physician (gold standard) cause of death
San Carlos University
Guatemala City, Guatemala
Aga Khan University
Karachi, Pakistan
Kinshasa School of Public Health
Kinshasa, Republic of the Congo
University of Zambia
Lusaka, Zambia
Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel
Time frame: 7-days
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
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
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