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Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

NCT00640055 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-07-31

No results posted yet for this study

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.

Conditions

  • Perinatal Mortality
  • Cause of Neonatal Death
  • Cause of Stilbirth

Interventions

OTHER

Coordinator

Coordinator (non-physician) assigned cause of death

OTHER

Physician-assigned cause of death

Physician (gold standard) cause of death

Sponsors & Collaborators

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

    lead NETWORK

Principal Investigators

  • Marion Koso-Thomas, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Cyril Engmann · UNC at CHapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-05-31
Completion
2008-07-31

Countries

  • Guatemala
  • Pakistan
  • Republic of the Congo
  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00640055 on ClinicalTrials.gov