BASELINE: Babies After Scope: Evaluating the Longitudinal Impact Using Neurological and Nutritional Endpoints
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,185
- 试验地点
- 1
- 主要终点
- To establish a longitudinal birth cohort study to examine early life environment and effect on childhood illness
研究概览
简要总结
The Departments of Paediatrics and Child Health, Obstetrics/Gynaecology and Nutritional Sciences, University College Cork, and the Department of Dermatology, Trinity College, Dublin have a unique and urgent opportunity to form a birth cohort of over 2000 children whose growth and maternal health status will have been closely monitored from early pregnancy. Longitudinal monitoring of these infants will allow direct investigation of several research areas in a way which has not previously been possible in Ireland, or abroad. The investigators propose to focus on three main research themes: the effects of intrauterine growth restriction, the incidence and prevalence of food allergy and eczema in early childhood and the incidence and effects of maternal and infant vitamin D status on the growth and health of Irish children. Although the investigators initial proposal will focus on these important areas, the formation of this birth cohort will offer many opportunities for further research as the cohort grows older. It will form a unique bio-bank of information from Irish children collected longitudinally from soon after their conception. The mothers of these infants are currently being recruited, which leaves us with a narrow window of opportunity to put in place a pathway of investigation for these children. To ignore this opportunity would be to lose access to a wealth of information regarding child health and disease. The potential for this cohort to provide definitive answers to current, and future, theories of disease causation is enormous.
详细描述
SPECIFIC AIMS:
Our underlying aim is to establish a prospective paediatric birth cohort which will have access to detailed information on maternal health, fetal growth, and childhood nutrition, growth and development in the first 2 years of life. This cohort will have the advantage of a stored biobank of maternal and fetal plasma, serum and DNA. This cohort will allow us to monitor the effects of intrauterine growth and nutrition on early life illnesses.
Our specific aims are:
- To establish the fetal and early life growth trajectories which foretell later neurocognitive disability and metabolic disorder
- To establish the incidence and prevalence of food allergy and eczema in Irish children and investigate the relationship between Vitamin D deficiency and allergic disorders of early childhood.
- To establish the prevalence of maternal and neonatal vitamin D deficiency in an Irish paediatric population
Introduction:
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
- •All liveborn infants whose mothers were recruited to the SCOPE Ireland study at 15 weeks gestation.
- •Singleton pregnancies, no previous history or risk of pre-eclampsia
排除标准
- •Stillbirths, or mothers who do not consent to paediatric follow up.
结局指标
主要结局
To establish a longitudinal birth cohort study to examine early life environment and effect on childhood illness
时间窗: 24 months
次要结局
- To establish the prevalence of maternal and neonatal vitamin D deficiency in an Irish paediatric population(24 months)
- To establish the incidence and prevalence of food allergy and eczema in Irish children and investigate the relationship between Vitamin D deficiency and allergic disorders of early childhood(24 months)
- To establish the fetal and early life growth trajectories which foretell later neurocognitive disability and metabolic disorder(24 months)
