Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development
试验速览
- 阶段
- 不适用
- 入组人数
- 1,796
- 试验地点
- 8
- 主要终点
- Diarrhea
研究概览
简要总结
Malnutrition is considered one of the most prevalent risk factors for morbidity and mortality in children under five. An estimated 20% of children in the developing world are malnourished [1] and poor nutrition is linked to more than half of all child deaths worldwide [2]. Malnutrition in early childhood may lead to cognitive and physical deficits and may cause similar deficits in future generations as malnourished mothers give birth to low birth weight children [3]. In addition, malnutrition increases susceptibility and incidence of infections and is associated with diminished response to vaccines.
The MAL-ED Project is designed to determine the impact of enteric infections/diarrhea that alter gut function and impair children's nutrition, growth and development to help develop new intervention strategies that can break the vicious enteric infection-malnutrition cycle and reduce its global burden.
The overall objective of the MAL-ED Project is to quantify the associations of specific enteric pathogens, measures of physical and mental development, micronutrient malnutrition, gut function biomarkers, the gut microbiome, and immune responses in very young children in resource-limited settings across eight sites that vary by culture, economics, geography, and climate.
The central hypothesis of the MAL-ED Project is that infection (and co-infection) with specific enteropathogens leads to impaired growth and development and to diminished immune response to orally administered vaccines by causing intestinal inflammation and/or by altering intestinal barrier and absorptive function. Data analyses will test for associations between enteropathogen infections and growth/development to help illuminate:
- which micro-organisms or mixed infections are most frequently associated with growth faltering and poor development; and
- at what age specific infections cause the most disruption to growth and development and impair immune response.
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 Minute 至 17 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Less than 17 days old.
排除标准
- •Mother is less than 16 years of age.
- •Mother has another child inthe MAL-ED study.
- •Pregnancy resulted in multiple birth (e.g., twins).
- •Child has a severe disease requiring hospitalization for something other than for a typical healthy birth.
- •Child has a severe or chronic condition diagnosed by a medical doctor (e.g., neonatal disease, renal disease, chronic heart failure, liver disease, cystic fibrosis, congenital conditions).
- •Child has enteropathies diagnosed by medical doctor.
- •Mother is living and unable to provide informed consent.
结局指标
主要结局
Diarrhea
时间窗: Each diarrheal episode willbe recorded for up to 24 months of age.
All diarrheal samples are analyzed for the presence of bacterial, viral, and parasitic pathogens. Normal stool is collected monthly and analyzed for the same list of 57 different pathogens.
Anthropometry
时间窗: Anthropomentry will be recorded each month for up to 24 months of age.
Head Circumference, length, and weight are measured monthly on the anniversary of the child's birth.
Cognitive development
时间窗: Cognitive development will be recorded 24 months of age.
A battery of tests include the Bayley Scales of Infant Development, MacArthur Words and Gestures, Infant Temperament Scale, HOME inventory, SRQ-20 and Raven's Combined Progressive Matrices.
Vaccine response
时间窗: Vaccine response will be recorded at 24 months of age.
Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.
次要结局
- Gut integrity(Gut integritywill be recorded at at 15 months of age.)
- Gut inflammation(Gut inflammation will be recorded each month for up to 24 months of age.)