Molecular Signature of Karen and Burmese Children Until Two Years of Age on the Thailand--Myanmar Border: a Study Extension of TMEC 15-062
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Characterization of the molecular signature of child
研究概览
简要总结
Preterm birth (PTB) occurs before 37 weeks of gestation and is a major cause of neonatal mortality and morbidity. PTB results from heterogeneous influences. One of them is the inherited predisposition of spontaneous PTB, and another is the change in the placental microbial composition as this can cause infections, which lead to inflammation, a common cause of preterm birth. Interestingly, maternal periodontal disease is an independent risk factor for PTB, low birth weight and fetal growth restriction. Immune responses to infectious events or inflammation as well as genetic predisposition to inherited conditions have successfully been studied by using assessing genetic expression profiling. The molecular signature is sets of genes, proteins, genetic variants or other variables that can be used as markers for a particular phenotype.
Child morbidity from malnutrition resulting in poor growth and stunting remains a major public health issue that affects the local population just like PTB. While risk factors for malnutrition are multifaceted, there is also a hypothesized causal link between early gut microbiome disruption that leads to chronic malnutrition in otherwise healthy infants.
Molecular signatures including the intestinal microbiome development of preterm infants will be evaluated and compared to the term (≥37 weeks' gestation) counterparts. Moreover, a comprehensive examination of possible factors associated with poor growth and poor motor- and neurodevelopment will be assessed.
In this extension study: The primary goal for the child is to evaluate the perturbation in the development of the genomic profile including intestinal microbial habitat from children in a rural and limited-resource setting from birth to two years of life.
详细描述
Rationale:
The importance of early life epigenetics is now recognized to have direct implications for health in later life and a consistent limitation expressed in peer reviewed publications has been the small sample size of the studies. Rather than establish a separate cohort to study epigenetics in young children in this environment this extension study of TMEC 15-062 (Molecular signature of Karen and Burmese women on the Thailand--Myanmar border) aims to build on the detailed sampling of the mothers to not only identify biomarkers of preterm labor but also to understand high rates of stunting and anaemia in this area, and possibly develop predictive tools or pave new ways for prevention in the future.
Moreover, a non-invasive intervention in the form of nutrition and WASH counselling may provide information on whether this form of engagement can positively influence child development, prevent malnutrition and whether perturbations in the infants molecular signature can be observed.
In addition, the mothers exposed to the sampling procedure at birth in this study will be able to make a well-informed decision about whether they wish to enrol the child in such a study.
The rationale for the planned samples in children born to mothers who participated in the TMEC 15-062 study are summarized in the following text:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Karen or Burmese pregnant woman in study TMEC 15-062 who are willing to have their offspring (children) comply with all study requirements
- •Pregnant woman is willing and able to give informed consent for her child to participate in this study
排除标准
- •Children (in the investigators opinion) with any social or physical condition which would make it difficult to comply with study requirements
- •Inclusion Criteria for water, sanitation and hygiene (WASH) radomization
- •Mother enrolled to MSP (TMEC 15-062) and child enrolled in MSP_Ext (TMEC 17-008)
- •Term pregnancy (gestational age ≥37 weeks)
- •Clinic birth
- •Normal new-born
- •Post-partum mother willing to have home visits
- •Post-partum mother willing and able to give informed consent to participate in this study
- •Exclusion Criteria for water, sanitation and hygiene (WASH) randomization
- •Lives too far to make home visits feasible
- •Home situation unstable and likely to move before the child is 9 months old
- •Social situation that would make it difficult for the mother to comply
结局指标
主要结局
Characterization of the molecular signature of child
时间窗: 2 years
Early childhood Transcriptome from capillary blood
Proportions of nutrition and water, sanitation and hygiene (WASH) behaviours in home-based compared to clinic-based care
时间窗: 9 months
Characterization of the molecular signature of child
时间窗: at birth
Early childhood Transcriptome from capillary blood
Characterization of the molecular signature of child
时间窗: 1 year
Early childhood Transcriptome from capillary blood
次要结局
- Proportion of children with biomarkers perturbations associated with poor child growth(From birth to two years of life.)
- Proportion of children with biomarkers perturbations associated with neurocognitive and motor development(From birth to two years of life.)
- Proportion of children with biomarkers perturbations associated with anaemia(From birth to two years of life.)
- Association between nutrition and water, sanitation and hygiene (WASH) behaviours and biomarker signature perturbations in children(9 months)