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临床试验/NCT02793336
NCT02793336已完成不适用

Early Life Cohort in Papua Indonesia (ELIPI Study)

Menzies School of Health Research1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
P. vivax parasitaemia (PCR or microscopy)

研究概览

简要总结

Malaria remains an important cause of illness in young infants. Our clinical and epidemiological studies in Papua (Indonesia) have shown the magnitude of malaria morbidity in infants in the first 5 years of life, including recurrent episodes of malaria, anaemia, malnutrition and coinfection. Together these contribute significantly morbidity in early life, and almost certainly to the very high infant mortality rates in this region. However the body of knowledge around infant malaria outside of Africa, where both species P. vivax and P. falciparum are prevalent is considerable smaller. The impact of recurrent vivax malaria and severe anaemia on neurodevelopment and growth in young children is unknown in Papua.

This study therefore aims to provide longitudinal data on the incidence of symptomatic and asymptomatic malaria (P. falciparum and P. vivax) and the associated risk of anaemia. It also provides an opportunity to assess incidence risk of non-malaria febrile illnesses and bacterial co-infections and the long term outcomes in terms of neurodevelopment and growth in a vulnerable age group. The study is a continuation from two already established cohort studies: "STOP MIP", which enrolled pregnant women and followed them until delivery and a "baby-cohort", which enrolled babies from mothers included in the cohort and followed them through their first year of life. Continuous follow up of those babies until they are 4 years old will increase our understanding of long term impact especially of vivax malaria. The cohort will be linked to a randomized controlled trial (RCT) and will offer cohort patients to be enrolled into the RCT when they are diagnosed with malaria (symptomatic), allowing to estimate treatment effectiveness.

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
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient enrolled in the Baby-Cohort study

排除标准

  • Patients not enrolled in the Baby-Cohort study

结局指标

主要结局

P. vivax parasitaemia (PCR or microscopy)

时间窗: 1 year

The incidence rate of any P. vivax parasitaemia (PCR or microscopy) over 1 year in all infants

次要结局

  • symptomatic P. vivax(1 year)
  • severe anaemia (Hb<7g/dl) and/or blood transfusion(4 years)
  • serious illnesses including hospitalization(4 years)
  • non-malarial febrile episodes and bacterial co-infections(4 years)
  • Fluorescence spot test results (FST)(1 year)
  • mortality(4 years)
  • growth retardation and neurodevelopment delay(4 years)
  • G6PD activity(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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