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Completed

NCT Number: NCT00640055

Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

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.

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Key information

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Carlos University, Guatemala City, Guatemala

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neonatal death with 7-days or stillbirth
  • Lives in study cluster

Exclusion criteria

  • Mother died
  • Delivery in hospital setting

Treatment and study plan

Coordinator

Other

Coordinator (non-physician) assigned cause of death

Physician-assigned cause of death

Other

Physician (gold standard) cause of death

Primary outcomes

  1. Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel

    Time frame: 7-days

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

NICHD Global Network for Women's and Children's Health

Network

Registry information

Official study title

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

Acronym: VA

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 20, 2008
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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