VA: Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

Sponsor

NICHD Global Network for Women's and Children's Health (Other)

Overall Status

Completed

CT.gov ID

NCT00640055

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jul 1, 2007

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

Jul 1, 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

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

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 7 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	Country
1	Kinshasa School of Public Health	Kinshasa	Congo
2	San Carlos University	Guatemala City	Guatemala
3	Aga Khan University	Karachi	Pakistan
4	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