FindMyKOL
Clinical trialNCT00640055CompletedPhase 4Interventional

Verbal Autopsy to Assess Early Neonatal Death and Stillbirth

SponsorNICHD Global Network for Women's and Children's HealthEnrollment200Cause of Neonatal DeathCause of StilbirthPerinatal Mortality
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Cyril Engmann

    UNC at CHapel Hill

    Principal Investigator
  • Marion Koso-Thomas, MD

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Study Director

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Guatemala
  • San Carlos University

    Guatemala City, Guatemala

Pakistan
  • Aga Khan University

    Karachi, Pakistan

Republic of the Congo
  • Kinshasa School of Public Health

    Kinshasa, Republic of the Congo

Zambia
  • University of Zambia

    Lusaka, Zambia

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jul 2007
Primary completion
31 May 2008
Completion
31 Jul 2008
Last update posted
31 Jul 2014
Registered enrollment
200
Registry id
NCT00640055

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.