A Phase 4 interventional study of Coordinator and Physician-assigned cause of death in Perinatal Mortality, Cause of Neonatal Death and Cause of Stilbirth, sponsored by NICHD Global Network for Women's and Children's Health. Completed at 4 sites in 4 countries. Open to participants aged Up to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-31.
Sponsored by NICHD Global Network for Women's and Children's Health · Phase 4, Interventional, and Diagnostic
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.
120 studies on the registry are indexed under Perinatal Death; 25 are open to participants now.
This study's planned enrollment of 200 is below the median of 427 across 84 interventional studies indexed under Perinatal Death.
Browse Perinatal Death studies →NICHD Global Network for Women's and Children's Health is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Coordinator (non-physician)
Other: Coordinator
Physician
Other: Physician-assigned cause of death
Coordinator (non-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
The record gives a start of Jul 2007, a primary completion of May 2008 and a completion of Jul 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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NICHD Global Network for Women's and Children's Health