跳至主要内容
临床试验/NCT00640055
NCT00640055已完成4 期

Using Verbal Autopsy to Determine Cause of Stillbirths and Early Neonatal Deaths Within the NICHD Global Network

NICHD Global Network for Women's and Children's Health4 个研究点 分布在 4 个国家目标入组 200 人开始时间: 2007年7月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
200
试验地点
4
主要终点
Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
— 至 7 Days(Child)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •Mother died
  • •Delivery in hospital setting

研究组 & 干预措施

1

Active Comparator

Coordinator (non-physician)

干预措施: Coordinator (Other)

2

Placebo Comparator

Physician

干预措施: Physician-assigned cause of death (Other)

结局指标

主要结局

Cause of death as assigned by a Community Coordinator compared to the cause of death assigned by the physician panel

时间窗: 7-days

次要结局

  • The agreement between mothers' and birth attendants' responses on selected items on the VA questionnaire (considering the mothers' response as the reference standard).(7 days)
  • The COD for stillbirth as assigned by the Community Coordinator compared to the COD for stillbirth as assigned by the Physician Panel(7 days)

研究者

发起方
NICHD Global Network for Women's and Children's Health
申办方类型
Network
责任方
Sponsor

研究点 (4)

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