Verbal Autopsy to Assess Early Neonatal Death and Stillbirth (VA)

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00640055
First received: March 18, 2008
Last updated: December 4, 2008
Last verified: December 2007

March 18, 2008
December 4, 2008
July 2007
May 2008   (final data collection date for primary outcome measure)
Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel [ Time Frame: 7-days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00640055 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Verbal Autopsy to Assess Early Neonatal Death and Stillbirth
Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Diagnostic
  • Perinatal Mortality
  • Cause of Neonatal Death
  • Cause of Stilbirth
  • Other: Coordinator
    Coordinator (non-physician) assigned cause of death
  • Other: Physician-assigned cause of death
    Physician (gold standard) cause of death
  • Active Comparator: 1
    Coordinator (non-physician)
    Intervention: Other: Coordinator
  • Placebo Comparator: 2
    Physician
    Intervention: Other: Physician-assigned cause of death
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Mother died
  • Delivery in hospital setting
Both
up to 7 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Congo,   Guatemala,   Pakistan,   Zambia
 
NCT00640055
CP03, U01 HD 40636
Yes
Cyril Engmann, University of North Carolina at Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP