Verbal Autopsy to Assess Early Neonatal Death and Stillbirth (VA)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Perinatal Mortality Cause of Neonatal Death Cause of Stilbirth |
Other: Coordinator Other: Physician-assigned cause of death |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Diagnostic |
| Official Title: | Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network |
- Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel [ Time Frame: 7-days ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | up to 7 Days |
| Genders Eligible for Study: | Both |
| 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| 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 | |
| Study Director: | Linda L Wright | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Principal Investigator: | Cyril Engmann | UNC at CHapel Hill |
More Information
Additional Information:
No publications provided
| Responsible Party: | Cyril Engmann, University of North Carolina at Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00640055 History of Changes |
| Other Study ID Numbers: | CP03, U01 HD 40636 |
| Study First Received: | March 18, 2008 |
| Last Updated: | December 4, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
verbal autopsy stillbirth neonatal death |
Additional relevant MeSH terms:
|
Death Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013