Clinical Trial: Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network

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.


Detailed Summary:
Sponsor: NICHD Global Network for Women's and Children's Health

Current Primary Outcome: Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel [ Time Frame: 7-days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: NICHD Global Network for Women's and Children's Health

Dates:
Date Received: March 18, 2008
Date Started: July 2007
Date Completion:
Last Updated: July 29, 2014
Last Verified: July 2014