PC1 EDEN: A FRENCH STUDY OF PRE AND EARLY POST NATAL DETERMINANTS OF THE CHILD???S DEVELOPMENT AND HEALTH

Abstract

Introduction: The main objectives of the EDEN is 1-to confirm that the plasticity of the fetal and early life period may lead to a programming of some body functions by nutritionnal and other environmental conditions as soon as in utero; 2-to establish the contribution of these phenomenon to later health and development in comparison with other environmental factors operating during childhood. Methods: 3000 pregnant women will be recruited before 24 weeks of amenorrhea in two study centers Poitiers and Nancy). They will be followed with their child up to its fifth birthday. The following aspects of the child’s health and development will be monitored: growth and development of adiposity, metabolism and blood pressure, allergy and respiratory function, cognitive and behavioural development. The potential risk factors recorded during pregnancy and the first months of life will concern maternal health, metabolism, nutritional state and feeding, routine pregnancy monitoring (ultrasound exams, O’Sullivan test..), exposure to tobacco, toxics at home and at work, allergens, psycho-affective and social factors, baby’s feeding and early exposures, genetic factors. Data will be recorded through questionnaires to the mother (at inclusion, 6th month of pregnancy and after delivery) and the father, clinical examinations of the mother during the 6th month of pregnancy and after delivery. Biological material will be collected: urine, saliva and blood from the mother at 6th month of pregnancy, blood from the father, cord blood and placenta biopsy, milk from lactating mother, infant meconium. During infancy, questionnaire will be mailed to the parents. Parents and child will be invited for a clinical examination and cognitive development assessment at 1, 3 and 5 years. At this later examination, a blood sampling will be proposed to the child. The protocol has been approved by the ethics committee of Kremin-Bicêtre. Results: The study started in february 2003 in Poitiers and September 2003 in Nancy. By November 1st 2003, 407 women (61% of those eligible) have been included and 105 babies were born. 93% of the fathers agreed to participate. Conclusion: The expected results are a contribution to the understanding of the mechanisms underlying the programming effect of early nutrition and exposures, as well as providing a rationale for setting up preventive interventions and clinical trials in pregnant women and infants.