跳至主要内容
临床试验/NCT04285021
NCT04285021已完成不适用

Prediction of Disease Severity in Young Children Presenting With Acute Febrile Illness in Resource-limited Settings

Medecins Sans Frontieres, Spain6 个研究点 分布在 5 个国家目标入组 3,433 人开始时间: 2020年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,433
试验地点
6
主要终点
Risk prediction algorithm

研究概览

简要总结

Note that this is a study that is co-sponsored by Medecins Sans Frontieres, Spain, and the University of Oxford.

The primary objective is to develop a risk prediction algorithm, combining measurements of host biomarkers and clinical features at the point-of-triage, for children with an acute febrile illness in resource-limited settings.

The secondary objectives are to determine which host biomarkers, feasible for measurement at the point-of-care, are predictive of disease severity. Additionally to determine the optimal combination of clinical features (including demographics, anthropometric data, historical variables, vital signs, clinical signs and clinical symptoms), feasible for assessment by limited-skill health workers, that is predictive of disease severity.

The tertiary objectives are to explore the impact of different methods of outcome classification on development of the risk prediction algorithm, and to explore the performance of the algorithm to predict disease severity in key presenting clinical syndromes and aetiologies.

详细描述

Background

Febrile illnesses are amongst the most common reasons that parents seek non-routine healthcare for their children and a proportion progress to severe disease with substantial risk of mortality. Sepsis, defined as acute life-threatening organ dysfunction caused by a dysregulated host response to infection, carries significant morbidity. Incidence is highest in the paediatric age-range, with an estimated over four million children developing sepsis each year. This estimate is necessarily conservative, as the burden of sepsis is greatest in low- and middle-income countries (LMICs) where population-level data are not readily available.

Distinguishing febrile children that require referral or admission to hospital, from those who can safely be cared for in the community, is challenging. In many tropical settings rational triage is especially difficult: healthcare providers receive limited training, and many acute febrile syndromes are clinically indistinguishable yet have different disease trajectories and require different interventions. Particularly in conflict settings, referral decisions involve complex mechanisms, costs and risks to both patient and provider. Consequently, patient outcomes are compromised: children with severe disease go unrecognised, whilst those with milder illnesses are unnecessarily hospitalised.

Healthcare providers are trained to perform systematic clinical assessments, which focus on eliciting symptoms and signs that predict poor outcomes. Whilst tools such as the World Health Organization's Integrated Management of Childhood Illness (IMCI) aim to support this, results are inconsistent and adherence is poor. Integration of several syndrome-specific algorithms is impractical for many limited-skill health workers. A recent systematic review concluded that validity of existing paediatric triage tools is uncertain and that none are likely to be reliable in resource-constrained environments.

Numerous clinical severity scoring systems predict deterioration in hospitalised patients and recent attempts have been made to adapt these to the paediatric population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
28 Days 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Risk prediction algorithm

时间窗: 12-15 months

To predict disease severity for children with an acute febrile illness in resource-limited settings by combining measurements of host biomarkers and clinical features at the point-of-triage

次要结局

  • Biomarkers(12-15 months)
  • Clinical features of severity(12-15 months)

研究者

发起方
Medecins Sans Frontieres, Spain
申办方类型
Other
责任方
Sponsor

研究点 (6)

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