Cause of Neonatal Death, Cause of Stilbirth, Perinatal Mortality
Conditions
Keywords
verbal autopsy, stillbirth, neonatal death
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.
Interventions
OTHERCoordinator
Coordinator (non-physician) assigned cause of death
OTHERPhysician-assigned cause of death
Physician (gold standard) cause of death
Sponsors
NICHD Global Network for Women's and Children's Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
Yes
Inclusion criteria
* Neonatal death with 7-days or stillbirth * Lives in study cluster
Exclusion criteria
* Mother died * Delivery in hospital setting
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Guatemala, Pakistan, Republic of the Congo, Zambia
Outcome results
None listed