NCT00640055

Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: NICHD Global Network for Women's and Children's Health · Network
• Sex: All
• Age: 7 Days
• Healthy volunteers: Accepted

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.

Conditions

• Perinatal Mortality
• Cause of Neonatal Death
• Cause of Stilbirth

Interventions

Type	Name	Description
OTHER	Coordinator	Coordinator (non-physician) assigned cause of death
OTHER	Physician-assigned cause of death	Physician (gold standard) cause of death

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-05-01
• Completion: 2008-07-01
• First posted: 2008-03-20
• Last updated: 2014-07-31

Locations

4 sites across 4 countries: Guatemala, Pakistan, Republic of the Congo, Zambia