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

• ClinicalTrials.gov Identifier: NCT00640055
• Recruitment Status: Completed
• First Posted: March 20, 2008
• Last Update Posted: July 31, 2014
• Sponsor: NICHD Global Network for Women's and Children's Health
• Information provided by (Responsible Party): NICHD Global Network for Women's and Children's Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Perinatal Mortality; Cause of Neonatal Death; Cause of Stilbirth	Other: Coordinator; Other: Physician-assigned cause of death	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Diagnostic
• Official Title: Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network
• Study Start Date: July 2007
• Actual Primary Completion Date: May 2008
• Actual Study Completion Date: July 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Coordinator (non-physician)	Other: Coordinator; Coordinator (non-physician) assigned cause of death
Placebo Comparator: 2; Physician	Other: Physician-assigned cause of death; Physician (gold standard) cause of death

Outcome Measures

Primary Outcome Measures :

1. Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel [ Time Frame: 7-days ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: up to 7 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Mother died
• Delivery in hospital setting

Contacts and Locations

Locations

Congo

Kinshasa School of Public Health

Kinshasa, Congo

Guatemala

San Carlos University

Guatemala City, Guatemala

Pakistan

Aga Khan University

Karachi, Pakistan

Zambia

University of Zambia

Lusaka, Zambia

Sponsors and Collaborators

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

Investigators

• Study Director: Marion Koso-Thomas, MD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Principal Investigator: Cyril Engmann; UNC at CHapel Hill

More Information

Additional Information:

Global Network 

• Responsible Party: NICHD Global Network for Women's and Children's Health
• ClinicalTrials.gov Identifier: NCT00640055
• Other Study ID Numbers: CP03; U01HD040636 ( U.S. NIH Grant/Contract )
• First Posted: March 20, 2008
• Last Update Posted: July 31, 2014
• Last Verified: July 2014

Keywords provided by NICHD Global Network for Women's and Children's Health:

verbal autopsy; stillbirth; neonatal death

Additional relevant MeSH terms:

Stillbirth; Perinatal Death; Death; Pathologic Processes; Fetal Death; Pregnancy Complications