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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00640055
First received: March 18, 2008
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Perinatal Mortality
Cause of Neonatal Death
Cause of Stilbirth
Other: Coordinator
Other: Physician-assigned cause of death
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Diagnostic
Official Title: Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Coordinator (non-physician)
Other: Coordinator
Coordinator (non-physician) assigned cause of death
Placebo Comparator: 2
Physician
Other: Physician-assigned cause of death
Physician (gold standard) cause of death

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Mother died
  • Delivery in hospital setting
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640055

Locations
Congo
Kinshasa School of Public Health
Kinshasa, Congo
Guatemala
San Carlos University
Guatemala City, Guatemala
Pakistan
Aga Khan University
Karachi, Pakistan
Zambia
University of Zambia
Lusaka, Zambia
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Investigators
Study Director: Marion Koso-Thomas, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Cyril Engmann UNC at CHapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00640055     History of Changes
Other Study ID Numbers: CP03, U01 HD 40636
Study First Received: March 18, 2008
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
verbal autopsy
stillbirth
neonatal death

Additional relevant MeSH terms:
Death
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014