Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

NCT ID: NCT00640055

Last Updated: 2014-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-07-31

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.

Conditions

Perinatal Mortality; Cause of Neonatal Death; Cause of Stilbirth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

1

Coordinator (non-physician)

Group Type: ACTIVE_COMPARATOR

Coordinator

Intervention Type: OTHER

Coordinator (non-physician) assigned cause of death

2

Physician

Group Type: PLACEBO_COMPARATOR

Physician-assigned cause of death

Intervention Type: OTHER

Physician (gold standard) cause of death

Interventions

Coordinator

Coordinator (non-physician) assigned cause of death

Intervention Type: OTHER

Physician-assigned cause of death

Physician (gold standard) cause of death

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Mother died
• Delivery in hospital setting

• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marion Koso-Thomas, MD

Role: STUDY_DIRECTOR

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Cyril Engmann

Role: PRINCIPAL_INVESTIGATOR

UNC at CHapel Hill

Locations

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

Countries

Guatemala; Pakistan; Republic of the Congo; Zambia

Related Links

http://gn.rti.org

Global Network

Other Identifiers

U01HD040636

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CP03

Identifier Type: -

Identifier Source: org_study_id