Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Late Preterm and Term Neonates in Uganda and Zimbabwe
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 2
- 主要终点
- Positive blood culture amongst neonatal participants
研究概览
简要总结
The goal of this observational study is to develop a risk prediction model for early-onset neonatal sepsis in term and late preterm neonates in Uganda and Zimbabwe.
The main questions it aims to answer are:
- What are the risk factors for early-onset neonatal sepsis in low-resource settings?
- How can these be combined into a risk prediction model?
Mother-baby pairs will be recruited in Uganda. They will have extensive data taken on their medical and obstetric histories and lifestyles, and their newborns will have a blood sample taken just after birth for culture. Machine learning techniques will be used to create the risk prediction model, which will then be validated in a second population in Zimbabwe.
详细描述
There will be three main phases to this study, which is an observational cohort study.
Phase 1 will take place at Kawempe Hospital in Kampala, Uganda. Participants will be recruited from labour wards by study staff, and interim analysis will be completed after recruitment of 10% of the total sample. See section 7.3 for further details.
Data will be collected via an online CRF, including the factors listed in the table in Section 3.
Additionally:
- All neonates within the study will have a neonatal venous blood sample taken for culture by designated study staff
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Positive blood culture amongst neonatal participants
时间窗: Sample taken in first 48 hours of life
Venous blood culture processed on BACTEC machine
次要结局
- Documented clinical diagnosis of sepsis amongst neonatal participants(Within first 72 hours of life)
- Clinical features of neonatal sepsis(Within first 72 hours of life)
- Readmission to hospital in first 28 days amongst neonatal participants(Within 28 days of birth)
- Death before 28 days of age(Within 28 days of birth)
- Admission to neonatal unit(Within first 72 hours of life)