Verbal Autopsy to Assess Early Neonatal Death and Stillbirth (VA)
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ClinicalTrials.gov Identifier: NCT00640055 |
Recruitment Status :
Completed
First Posted : March 20, 2008
Last Update Posted : July 31, 2014
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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 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 |
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 |
- Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel [ Time Frame: 7-days ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | up to 7 Days (Child) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640055
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: | Marion Koso-Thomas, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | |
Principal Investigator: | Cyril Engmann | UNC at CHapel Hill |
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 Key Record Dates |
Last Update Posted: | July 31, 2014 |
Last Verified: | July 2014 |
verbal autopsy stillbirth neonatal death |
Stillbirth Perinatal Death Death |
Pathologic Processes Fetal Death Pregnancy Complications |