Verbal Autopsy to Assess Early Neonatal Death and Stillbirth (VA)

NICHD Global Network for Women's and Children's Health

Status and phase: Completed; Phase 4

Conditions: Cause of Stilbirth; Perinatal Mortality; Cause of Neonatal Death

Treatments: Other: Coordinator; Other: Physician-assigned cause of death

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00640055

CP03

U01HD040636 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 7 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Neonatal death with 7-days or stillbirth
• Lives in study cluster

Exclusion criteria

• Mother died
• Delivery in hospital setting

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Coordinator (non-physician)

Treatment:

Other: Coordinator

2

Placebo Comparator group

Description:

Physician

Treatment:

Other: Physician-assigned cause of death