Ethanol, Neurodevelopment, Infant and Child Health (ENRICH) prospective cohort: Study design considerations.

Background: While intervention is the leading factor in reducing long-term disabilities in children with fetal alcohol spectrum disorder (FASD), early identification of children affected by prenatal alcohol exposure (PAE) remains challenging. Deficits in higher-order cognitive domains (e.g. executive function) might be more specific to FASD than global neurodevelopmental tests, yet these functions are not developed in very young children. Measures of early sensorimotor development may provide early indications of atypical brain development during the first two years of life.

Methods: This paper describes the novel methodology of the Ethanol, Neurodevelopment, Infant and Child Health (ENRICH) prospective cohort study of 120 maternal-infant pairs with a goal to identify early indices of functional brain impairment associated with PAE. The cohort is established by recruiting women early in pregnancy and classifying them into one of three study groups: patients on opioid-maintenance therapy who consume alcohol during pregnancy (Group 1), patients on opioid-maintenance therapy who abstain from alcohol during pregnancy (Group 2), and healthy controls (Group 3). After the initial prenatal assessment (Visit 1), patients are followed to Visit 2 occurring at delivery, and two comprehensive assessments of children at six (Visit 3) and 20 months (Visit 4) of age. ENRICH recruitment started in November 2013 and 87 women were recruited during the first year. During Year 1, the biospecimen (maternal whole blood, serum, urine, dry blood spots of a newborn) collection rate was 100% at Visit 1, and 97.6% for those who completed Visit 2.

Discussion: The tiered screening approach, evaluation of confounders, neurocognitive and magneto-/electro-encephalography (MEG/EEG) outcomes, and ethical considerations are discussed.