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临床试验/NCT02800109
NCT02800109已完成不适用

Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth - Child Follow-up Until 2 Years of Age, in Relation to the Fetal Growth

University of Oxford1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
1
主要终点
The proportion of children with sub-optimal growth by 2 years of age among children born to mother exposed to malaria and those born to mother non-exposed to malaria

研究概览

简要总结

The purpose of this study is to measure the impact of maternal malaria on child growth in the two first years of life in relation to fetal growth.

This study is following a birth cohort of children born to pregnant women enrolled in the study "Impact of malaria infection in pregnancy on fetal and newborn growth" (protocol OXTREC 14 08 and Mahidol 2009-003-01). In this cohort growth monitoring is conducted until 2 years of age using routine anthropometric measurements such as weight, length, arm and head circumference. A few additional tests will enhance the sensitivity of the study outcomes with minimal risk. These tests will include anthropometry, screening, nutrition questionnaire and neurodevelopmental assessment.

This study was funded by Wellcome Trust core funding, grant ref. number Wellcome Trust Major Overseas Program Grant no. 220211 (2020-2025)

详细描述

This is an existing on-going prospective birth cohort of children born to the pregnant women who had fetal growth assessed during pregnancy. In this cohort an expected 10% of pregnant women will be exposed to malaria while the remaining will be free of malaria. Their offspring are already followed up for growth monitoring from birth until 2 years of age with anthropometric measurements including weight, length, arm and head circumference at each scheduled visit. The investigator would like to enhance the sensitivity of the study outcomes with minimal risk for the child by proposing the following anthropometric and screening tests, nutrition questionnaire, and neurodevelopment assessment. In addition a prospective cohort of children born after study approval will be followed on both protocols. The additional measure include:

  • Body fat composition (at birth, and monthly up to 4 months unless weight ≥ 8kg)
  • Triceps and subscapular skinfold (at 1 and 2 years)
  • Anemia, malaria and soil-transmitted helminths screening (every 3 months in first 12 months and 6-monthly 1-2 years)
  • Buccal swab (at 1 and 2 years)
  • Neurodevelopment (every 6 months)
  • Food questionnaire (at 1 and 2 years)

Summary of results:

The beginning of the recruitment was delayed until the finalization and approval of the translated PIS/ICF; from then on, the recruitment was smooth. Overall, 201 children from the ongoing existing birth cohort were still present and eligible to participate in this part of the study; 173 completed 2 years of FUP 28 were lost. Data and samples from these 173 children were included in the analysis of a large, multi-center, study, the INTERBIO-21st.

The pooled findings show 1. Cognitive development, language, and visual skills at 2 years of age vary according to the trajectories of fetal cranial growth 2. There is a critical window period at 20-25 weeks gestational age when fetal cranial trajectories may diverge and when fetal abdominal circumference growth may accelerate or decelerate 3. Preterm newborn's growth and neurocognitive development vary according to their birth phenotype characteristics (i.e. those classified in the "birth infections" phenotype were at higher risk for poor scoring in fine and gross motor development compared to term newborns) 4. An indication of a greater increase in weight in proportion to height during the 2 first years of life if there was a faltering growth phenotype observed during gestation.

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
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participant's parent or legal guardian is willing and able to give informed consent for participation in the study
  • Able (in the Investigators opinion) to comply with study requirements

排除标准

  • The participant may not enter the study if ANY of the following apply:
  • Medical or congenital complications which would (in the investigator's opinion) make it difficult to comply with study requirements
  • Aged older than 2 years

结局指标

主要结局

The proportion of children with sub-optimal growth by 2 years of age among children born to mother exposed to malaria and those born to mother non-exposed to malaria

时间窗: up to 2 years of age

次要结局

  • The median neurocognitive scores by growth groups and malaria-exposed groups(up to 2 years of age)
  • The median age of onset of anemia by growth groups and malaria-exposed Groups(up to 2 years of age)
  • Characterize of molecular signatures (methylation profile of the DNA) by growth groups and malaria-exposed groups(up to 2 years of age)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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