Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

Perinatal Mortality Clinical Trial

— VA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640055
• Other study ID #: CP03
• Secondary ID: U01HD040636
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: July 29, 2014
• Start date: July 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2014
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

• Neonatal death with 7-days or stillbirth

• Lives in study cluster

Exclusion Criteria:

• Mother died

• Delivery in hospital setting

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Other:
• Coordinator
Coordinator (non-physician) assigned cause of death
• Physician-assigned cause of death
Physician (gold standard) cause of death

Locations

Country	Name	City	State
Congo	Kinshasa School of Public Health	Kinshasa
Guatemala	San Carlos University	Guatemala City
Pakistan	Aga Khan University	Karachi
Zambia	University of Zambia	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
NICHD Global Network for Women's and Children's Health

Countries where clinical trial is conducted

Congo,  Guatemala,  Pakistan,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel		7-days	No
Secondary	The COD for stillbirth as assigned by the Community Coordinator compared to the COD for stillbirth as assigned by the Physician Panel		7 days	No
Secondary	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	No

External Links

•   Global Network