Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

NCT00640055 | Completed Phase 4 DMC

• 2 other identifiers: CP03U01HD040636
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 4

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

Keywords

verbal autopsy; stillbirth; neonatal death

Outcome Measures

Primary Outcomes (1)

• Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel

  7-days

Secondary Outcomes (2)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Coordinator (non-physician)

Other: Coordinator

2

PLACEBO COMPARATOR

Physician

Other: Physician-assigned cause of death

Interventions

Coordinator OTHER

Coordinator (non-physician) assigned cause of death

1

Physician-assigned cause of death OTHER

Physician (gold standard) cause of death

2

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Mother died
• Delivery in hospital setting

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead

Study Sites (4)

San Carlos University

Guatemala City, Guatemala

Location

Aga Khan University

Karachi, Pakistan

Location

Kinshasa School of Public Health

Kinshasa, Republic of the Congo

Location

University of Zambia

Lusaka, Zambia

Location

Related Links

• Global Network

MeSH Terms

Conditions

Perinatal Death; Stillbirth

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Death

Study Officials

• Marion Koso-Thomas, MD

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

  STUDY DIRECTOR

• Cyril Engmann

  UNC at CHapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 20, 2008
• Study Start: July 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

ZA (1); PA (1); GU (1); RE (1)