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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00640055 |
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 |
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Perinatal Mortality Cause of Neonatal Death Cause of Stilbirth |
Other: Coordinator Other: Physician-assigned cause of death |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Double Blind (Subject, Caregiver), Single Group Assignment, Efficacy Study |
Official Title: | Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network |
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 |
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1: Active Comparator
Coordinator (non-physician)
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Other: Coordinator
Coordinator (non-physician) assigned cause of death
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2: Placebo Comparator
Physician
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Other: Physician-assigned cause of death
Physician (gold standard) cause of death
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Ages Eligible for Study: | up to 7 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | University of North Carolina at Chapel Hill ( Cyril Engmann ) |
Study ID Numbers: | CP03, U01 HD 40636 |
Study First Received: | March 18, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00640055 |
Health Authority: | United States: Federal Government |
verbal autopsy stillbirth neonatal death |
Death |
Pathologic Processes |