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.

[1]  H. Hoyme,et al.  Prevalence and Characteristics of Fetal Alcohol Spectrum Disorders , 2014, Pediatrics.

[2]  Sarah J. Erickson,et al.  Associations between maternal scaffolding and executive functioning in 3 and 4 year olds born very low birth weight and normal birth weight. , 2014, Early human development.

[3]  S. Hintz,et al.  Corrigendum to “Early working memory as a racially and ethnically neutral measure of outcome in extremely preterm children at 18–22 months” [Early Hum. Dev. 89(12) (December 2013) 1055–1061] , 2014 .

[4]  L. Bakhireva,et al.  The validity of phosphatidylethanol in dried blood spots of newborns for the identification of prenatal alcohol exposure. , 2014, Alcoholism, clinical and experimental research.

[5]  S. Hintz,et al.  Early working memory as a racially and ethnically neutral measure of outcome in extremely preterm children at 18-22 months. , 2013, Early Human Development.

[6]  Sarah J. Erickson,et al.  Association of maternal scaffolding to maternal education and cognition in toddlers born preterm and full term , 2013, Acta paediatrica.

[7]  Arvind Caprihan,et al.  Delays in auditory processing identified in preschool children with FASD. , 2012, Alcoholism, clinical and experimental research.

[8]  D. Feig,et al.  False-positive meconium test results for fatty acid ethyl esters secondary to delayed sample collection. , 2012, Alcoholism, clinical and experimental research.

[9]  J. Phillips,et al.  Association of maternal interaction with emotional regulation in 4- and 9-month infants during the Still Face Paradigm. , 2012, Infant behavior & development.

[10]  K. Jones,et al.  Prenatal alcohol exposure patterns and alcohol-related birth defects and growth deficiencies: a prospective study. , 2012, Alcoholism, clinical and experimental research.

[11]  M. Berchicci,et al.  Development of Mu Rhythm in Infants and Preschool Children , 2011, Developmental Neuroscience.

[12]  Jin Fan,et al.  Comparing Attentional Networks in Fetal Alcohol Spectrum Disorder and the Inattentive and Combined Subtypes of Attention Deficit Hyperactivity Disorder , 2011, Developmental neuropsychology.

[13]  M. Stanton,et al.  Biobehavioral Markers of Adverse Effect in Fetal Alcohol Spectrum Disorders , 2011, Neuropsychology Review.

[14]  E. Riley,et al.  Fetal Alcohol Spectrum Disorders: An Overview , 2011, Neuropsychology Review.

[15]  P. Kodituwakku.  A neurodevelopmental framework for the development of interventions for children with fetal alcohol spectrum disorders. , 2010, Alcohol.

[16]  G. Koren,et al.  Heavy in utero ethanol exposure is associated with the use of other drugs of abuse in a high-risk population. , 2010, Alcohol.

[17]  J. Jacobson,et al.  Infant Symbolic Play as an Early Indicator of Fetal Alcohol-Related Deficit. , 2010, Infancy : the official journal of the International Society on Infant Studies.

[18]  C. Coles,et al.  Concurrent Alcohol Use or Heavier Use of Alcohol and Cigarette Smoking Among Women of Childbearing Age with Accessible Health Care , 2010, Prevention Science.

[19]  F. Wurst,et al.  CLINICAL STUDY/BIOMARKER: Phosphatidylethanol: normalization during detoxification, gender aspects and correlation with other biomarkers and self‐reports , 2010, Addiction biology.

[20]  Sarah J. Erickson,et al.  Early working memory and maternal communication in toddlers born very low birth weight , 2009, Acta paediatrica.

[21]  Karen E. Smith,et al.  A responsive parenting intervention: the optimal timing across early childhood for impacting maternal behaviors and child outcomes. , 2008, Developmental psychology.

[22]  Carmen Rasmussen,et al.  The effect of rehearsal training on working memory span of children with fetal alcohol spectrum disorder. , 2008, Research in developmental disabilities.

[23]  P. May,et al.  Language and literacy outcomes from a pilot intervention study for children with fetal alcohol spectrum disorders in South Africa. , 2007, Alcohol.

[24]  C. Coles,et al.  Socio-cognitive habilitation using the math interactive learning experience program for alcohol-affected children. , 2007, Alcoholism, clinical and experimental research.

[25]  John P. Allen,et al.  The alcohol use disorders identification test: an update of research findings. , 2007, Alcoholism, clinical and experimental research.

[26]  C. Ehlers,et al.  Association of the ADHIB*3 allele with alcohol-related phenotypes in Trinidad. , 2007, Alcoholism, clinical and experimental research.

[27]  David W. Haley,et al.  Infant stress reactivity and prenatal alcohol exposure. , 2006, Alcoholism, clinical and experimental research.

[28]  M. O’Connor,et al.  Executive Functioning Predicts Social Skills Following Prenatal Alcohol Exposure , 2006, Child neuropsychology : a journal on normal and abnormal development in childhood and adolescence.

[29]  Peter D Grunau,et al.  Electroencephalographic correlates of prenatal exposure to alcohol in infants and children: a review of findings and implications for neurocognitive development. , 2006, Alcohol.

[30]  M. Rothbart,et al.  Measurement of fine-grained aspects of toddler temperament: the early childhood behavior questionnaire. , 2006, Infant behavior & development.

[31]  J. Lowe,et al.  Impact of mother interactive style on infant affect among babies exposed to alcohol in utero. , 2006, Infant mental health journal.

[32]  S. Ebrahim,et al.  Prevalence of Risk Factors for Adverse Pregnancy Outcomes During Pregnancy and the Preconception Period—United States, 2002–2004 , 2006, Maternal and Child Health Journal.

[33]  Jason C. Allaire,et al.  Factor Structure and Validity of the Parenting Stress Index-Short Form , 2006, Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53.

[34]  Julian K. Davies,et al.  Prenatal alcohol and drug exposures in adoption. , 2005, Pediatric clinics of North America.

[35]  S. M. Carlson.  Developmentally Sensitive Measures of Executive Function in Preschool Children , 2005, Developmental neuropsychology.

[36]  Mark Schluchter,et al.  Poor Predictive Validity of the Bayley Scales of Infant Development for Cognitive Function of Extremely Low Birth Weight Children at School Age , 2005, Pediatrics.

[37]  B. Grant,et al.  Effectiveness of the derived Alcohol Use Disorders Identification Test (AUDIT-C) in screening for alcohol use disorders and risk drinking in the US general population. , 2005, Alcoholism, clinical and experimental research.

[38]  J. Höög,et al.  Functionality of allelic variations in human alcohol dehydrogenase gene family: assessment of a functional window for protection against alcoholism. , 2004, Pharmacogenetics.

[39]  F. Bookstein,et al.  Risk Factors for Adverse Life Outcomes in Fetal Alcohol Syndrome and Fetal Alcohol Effects , 2004, Journal of developmental and behavioral pediatrics : JDBP.

[40]  F. Wurst,et al.  On sensitivity, specificity, and the influence of various parameters on ethyl glucuronide levels in urine--results from the WHO/ISBRA study. , 2004, Alcoholism, clinical and experimental research.

[41]  David W. Haley,et al.  Infant stress and parent responsiveness: regulation of physiology and behavior during still-face and reunion. , 2003, Child development.

[42]  M. Rothbart,et al.  Studying infant temperament via the Revised Infant Behavior Questionnaire , 2003 .

[43]  Josef Parnas,et al.  A global perspective on genetic variation at the ADH genes reveals unusual patterns of linkage disequilibrium and diversity. , 2002, American journal of human genetics.

[44]  A. Salvator,et al.  Cognitive and motor outcomes of cocaine-exposed infants. , 2002, JAMA.

[45]  Karen E. Smith,et al.  The Role of Early Parenting in Children's Development of Executive Processes , 2002, Developmental neuropsychology.

[46]  R. Anton,et al.  Comparison of Bio-Rad %CDT TIA and CDTect as laboratory markers of heavy alcohol use and their relationships with gamma-glutamyltransferase. , 2001, Clinical chemistry.

[47]  J. Jacobson,et al.  Neurobehavioral effects of prenatal alcohol exposure at 26 months. , 1999, Neurotoxicology and teratology.

[48]  S. Jacobson.  Specificity of neurobehavioral outcomes associated with prenatal alcohol exposure. , 1998, Alcoholism, clinical and experimental research.

[49]  P. Huttenlocher,et al.  Regional differences in synaptogenesis in human cerebral cortex , 1997, The Journal of comparative neurology.

[50]  J. Jacobson,et al.  Predictive validity of infant recognition memory and processing speed to 7-year IQ in an inner-city sample , 1996 .

[51]  J. Jacobson,et al.  Teratogenic effects of alcohol on infant development. , 1993, Alcoholism, clinical and experimental research.

[52]  J. Jacobson,et al.  Maternal recall of alcohol, cocaine, and marijuana use during pregnancy. , 1991, Neurotoxicology and teratology.

[53]  G Block,et al.  A Reduced Dietary Questionnaire: Development and Validation , 1990, Epidemiology.

[54]  M. Russell,et al.  Early measures of maternal alcohol misuse as predictors of adverse pregnancy outcomes. , 1988, Alcoholism: Clinical and Experimental Research.

[55]  M. Church.  Chronic in utero alcohol exposure affects auditory function in rats and in humans. , 1987, Alcohol.

[56]  A. Diamond,et al.  Development of the ability to use recall to guide action, as indicated by infants' performance on AB. , 1985, Child development.

[57]  T. Kamarck,et al.  A global measure of perceived stress. , 1983, Journal of health and social behavior.

[58]  T. Brazelton,et al.  The infant's response to entrapment between contradictory messages in face-to-face interaction. , 1978, Journal of the American Academy of Child Psychiatry.

[59]  Gary J. Robertson,et al.  Bayley Scales of Infant and Toddler Development , 2017 .

[60]  Nancy Bayley,et al.  BAYLEY SCALES OF INFANT AND TODDLER DEVELOPMENT, THIRD EDITION (BAYLEY-III) , 2014 .

[61]  J. Jacobson,et al.  Protective effects of the alcohol dehydrogenase-ADH1B*3 allele on attention and behavior problems in adolescents exposed to alcohol during pregnancy. , 2014, Neurotoxicology and teratology.

[62]  Kristina R. Ciesielski,et al.  Pediatric MEG: Investigating Spatio-Temporal Connectivity of Developing Networks , 2014 .

[63]  L. Bakhireva,et al.  Focus On: Biomarkers of Fetal Alcohol Exposure and Fetal Alcohol Effects , 2011, Alcohol research & health : the journal of the National Institute on Alcohol Abuse and Alcoholism.

[64]  M. O’Connor,et al.  Intervention for individuals with fetal alcohol spectrum disorders: treatment approaches and case management. , 2009, Developmental disabilities research reviews.

[65]  J. Brooks-Gunn,et al.  Games Children Play: Observing Young Children's Self-Regulation Across Laboratory, Home, and School Settings. , 2004 .

[66]  P. May,et al.  Estimating the Prevalence of Fetal Alcohol Syndrome , 2001, Alcohol research & health : the journal of the National Institute on Alcohol Abuse and Alcoholism.

[67]  E P Riley,et al.  Neuropsychological comparison of alcohol-exposed children with or without physical features of fetal alcohol syndrome. , 1998, Neuropsychology.

[68]  Sheldon Cohen.  Perceived stress in a probability sample of the United States , 1988 .