Clinical trial NCT00640055: Verbal Autopsy to Assess Early Neonatal Death and Stillbirth
Official title: Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perinatal Mortality
Cause of Neonatal Death
Cause of Stilbirth
Keywords: verbal autopsy
stillbirth
neonatal death
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
First posted: 2008-03-20
Enrollment: 200
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Mother died
* Delivery in hospital setting

Primary outcomes:
measure: Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel
timeFrame: 7-days
Secondary outcomes:
measure: The COD for stillbirth as assigned by the Community Coordinator compared to the COD for stillbirth as assigned by the Physician Panel
timeFrame: 7 days
measure: The agreement between mothers' and birth attendants' responses on selected items on the VA questionnaire (considering the mothers' response as the reference standard).
timeFrame: 7 days
Other outcomes:
Locations:
city: Kinshasa
country: Congo
facility: Kinshasa School of Public Health
city: Guatemala City
country: Guatemala
facility: San Carlos University
city: Karachi
country: Pakistan
facility: Aga Khan University
city: Lusaka
country: Zambia
facility: University of Zambia
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Marion Koso-Thomas, MD
role: STUDY_DIRECTOR
affiliation: UNC at CHapel Hill
name: Cyril Engmann
role: PRINCIPAL_INVESTIGATOR
References: