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DRAFT – Current as of 10/22/2019WHAT IS THE RELATIONSHIP BETWEEN SEAFOOD CONSUMPTION DURINGPREGNANCY AND LACTATION AND NEUROCOGNITIVE DEVELOPMENT OF THEINFANT?: SYSTEMATIC REVIEW PROTOCOLThis document describes the protocol for a systematic review to answer the following question: Whatis the relationship between seafood consumption during pregnancy and lactation and neurocognitivedevelopment of the infant?This systematic review is being conducted by the 2020 Dietary Guidelines Advisory Committee,Dietary Fats and Seafood Subcommittee and staff from USDA’s Nutrition Evidence SystematicReview (NESR).NESR methodology for answering a systematic review question involves: searching for and selecting articles, extracting data and assessing the risk of bias of results from each included article, synthesizing the evidence, developing a conclusion statement, grading the evidence underlying the conclusion statement, and recommending future research.More information about NESR’s systematic review methodology is available on the NESR nes-advisory-committee-systematic-reviews.This document includes details about the methodology as it will be applied to the systematic reviewas follows: The analytic framework (p. 2) illustrates the overall scope of the question, including thepopulation, the interventions and/or exposures, comparators, and outcomes of interest. The literature search and screening plan (p. 3) details the electronic databases and inclusionand exclusion criteria (p. 3) that will be used to search for, screen, and select articles to beincluded in the systematic review. The literature search and screening results (p. 7) includes a list of included articles, and a listof excluded articles with the rationale for exclusion.This protocol is up-to-date as of: 10/22/2019.This version of the protocol contains updates to the following sections. The literature search and screening results section, now includes the flowchart of literaturesearch and screening results, citations for all articles included in the review, and the list ofarticles excluded at full-text screening with a rationale for exclusion.Question: What is the relationship between seafood consumption during pregnancy and lactation and neurocognitive1development of the infant?

DRAFT – Current as of 10/22/2019ANALYTIC FRAMEWORKThe analytic framework (Figure 1) illustrates the overall scope of the systematic review, including thepopulation, the interventions and/or exposures, comparators, and outcomes of interest. It alsoincludes definitions of key terms and identifies key confounders and other factors to be considered inthe systematic review. The inclusion and exclusion criteria that follow provide additional informationabout how parts of the analytic framework will be defined and operationalized for the review.Figure 1: Analytic frameworkQuestion: What is the relationship between seafood consumption during pregnancy and lactation and neurocognitive2development of the infant?

DRAFT – Current as of 10/22/2019LITERATURE SEARCH AND SCREENING PLANElectronic databasesListed below are the databases that will be searched to identify all potentially relevant articles thathave been published to address the systematic review question. Additional details regarding thesearch strategy will be published upon completion of the review, and are available upon requestprior to publication. Pubmed Cochrane Embase CINAHLInclusion and exclusion criteriaThis table provides the inclusion and exclusion criteria for the systematic review. The inclusionand exclusion criteria are a set of characteristics used to determine which articles identified in theliterature search will be included or excluded in the systematic review.Table 1. Inclusion and exclusion criteriaCategoryInclusion CriteriaExclusion CriteriaStudydesign Randomized controlled trials Uncontrolled trials Non-randomized controlled trials,including quasi-experimental andcontrolled before-and-after studies Case-control studies Cross-sectional studies Uncontrolled before-and-afterstudies Prospective cohort studies Retrospective cohort studies Narrative reviewsNested case-control studies Systematic reviews Meta-analysesQuestion: What is the relationship between seafood consumption during pregnancy and lactation and neurocognitive3development of the infant?

DRAFT – Current as of 10/22/2019CategoryInclusion CriteriaIntervention/ exposureSeafood consumption measured priorto outcome assessmentExclusion Criteria No measure of seafoodconsumption (i.e., studies thatonly examined biomarkers forconsumption) n-3 supplement studies whichdo not evaluate seafoodconsumption Studies evaluating infantformula with added DHA and/orEPAo Type (e.g., salmon, tuna bass)o Source (e.g., sea fresh water, farmed,wild)o Amount/frequency of intakeo Timing of exposure (e.g., age atintake)Dietary intake (e.g., from foodfrequency questionnaires, dietaryrecall, fish/seafood screeners) may bevalidated with biomarkers for PUFA orMeHg, but not substituted.Comparator Different types, sources, amounts, frequency, and/or timing of exposure ofseafood consumptionNo comparatorOutcomes Developmental milestones, including neurocognitive developmento Developmental domainsexamined via milestoneachievement and/orscales/indices, including: cognitive, language/communication, movement/physical, social/emotionalNo measure of neurocognitivedevelopment Academic performance Attention deficit disorder (ADD) orattention deficit/hyperactivity disorder(ADHD) Anxiety Depression Autism spectrum disorder (ASD) January 2000 to June 2019Date ofpublication Articles published prior toJanuary 2000 or after June2019Question: What is the relationship between seafood consumption during pregnancy and lactation and neurocognitive4development of the infant?

DRAFT – Current as of 10/22/2019CategoryInclusion CriteriaExclusion CriteriaPublicationstatus Articles that have been peer-reviewed Articles that have not beenpeer-reviewed and are notpublished in peer-reviewedjournals, including unpublisheddata manuscripts, reports,abstracts, and conferenceproceedingsArticles published in English Articles published in languagesother than EnglishLanguage of publicationCountryi Studies conducted in countries rankedas high or very high humandevelopment Studies conducted in countriesranked as medium or lowerhuman developmentStudyparticipants Human subjects At intervention/exposureNon-human subjects (e.g.,animal models or in-vitromodels) Age at outcome:o Females who are pregnantand/or lactating At outcomeo Males and femalesAge ofstudyparticipants Age at intervention or exposure:o Women during pregnancyand/or lactation Age at outcome:o Adults (ages 19-64 years)o Older adults (ages 65 yearsand older)o Infants and toddlers (0-24months)o Children (2-12 years)o Adolescents (13-18 years)Question: What is the relationship between seafood consumption during pregnancy and lactation and neurocognitive5development of the infant?

DRAFT – Current as of 10/22/2019CategoryInclusion CriteriaExclusion CriteriaHealthstatus ofstudyparticipants Studies that enroll participants who arehealthy and/or at risk for chronicdisease, including those with obesity Studies that enroll some participantsdiagnosed with a disease or with theneurocognitive development and/orhealth outcomes of interest Studies that enroll infants born full-term ( 37 weeks and 0/7 days gestationalage) Studies that enroll some infants bornpreterm (gestational age 37 weeksand 0/7 days), infants with low birthweight ( 2500g), and/or infants bornsmall for gestational age Studies that exclusively enrollparticipants diagnosed with adisease or hospitalized with anillness or injury. (For thiscriterion, studies thatexclusively enroll participantswith obesity will not beexcluded.)Studies that exclusively enrollparticipants with theneurocognitive developmentand/or health outcomes ofinterestStudies that exclusively enrollinfants born preterm(gestational age 37 weeks and0/7 days), infants with low birthweight ( 2500g), and/or infantsborn small for gestational ageiThe Human Development classification was based on the Human Development Index (HDI) rankingfrom the year the study intervention occurred or data were collected (UN Development Program. HDI1990-2017 HDRO calculations based on data from UNDESA (2017a), UNESCO Institute for Statistics(2018), United Nations Statistics Division (2018b), World Bank (2018b), Barro and Lee (2016) andIMF (2018). Available from: http://hdr.undp.org/en/data). If the study did not report the year in whichthe intervention occurred or data were collected, the HDI classification for the year of publication wasapplied. HDI values are available from 1980, and then from 1990 to present. If a study was conductedprior to 1990, the HDI classification from 1990 was applied. When a country was not included in theHDI ranking, the current country classification from the World Bank was used instead (The WorldBank. World Bank country and lending group) Available ase/articles/906519-world- country-and-lendinggroups).Question: What is the relationship between seafood consumption during pregnancy and lactation and neurocognitive6development of the infant?

DRAFT – Current as of 10/22/2019LITERATURE SEARCH AND SCREENING RESULTSThe flow chart (Figure 2) below illustrates the literature search and screening results for articlesexamining this systematic review question and a second question on seafood consumption duringchildhood and adolescence (up to 18 years of age) and neurocognitive development. The resultsof the electronic database searches, after removal of duplicates, were screened independently bytwo NESR analysts using a step-wise process by reviewing titles, abstracts, and full-texts todetermine which articles met the inclusion criteria. Refer to Table 2 Excluded Articles for therationale for each excluded full-text article. A manual search was done to find articles that werenot identified when searching the electronic databases; all manually identified articles are alsoscreened to determine whether they meet criteria for inclusion.Figure 2: Flow chart of literature search and screening resultsIncluded Articles1. Daniels JL, Longnecker MP, Rowland AS, Golding J. Fish intake during pregnancy and earlycognitive development of offspring. Epidemiology. bmed/15232398.Question: What is the relationship between seafood consumption during pregnancy and lactation and neurocognitive7development of the infant?

DRAFT – Current as of 10/22/20192. Davidson PW, Strain JJ, Myers GJ, Thurston SW, Bonham MP, Shamlaye CF, et al.Neurodevelopmental effects of maternal nutritional status and exposure to methylmercury fromeating fish during pregnancy. Neurotoxicology. med/18590763.3. Deroma L, Parpinel M, Tognin V, Channoufi L, Tratnik J, Horvat M, et al. Neuropsychologicalassessment at school-age and prenatal low-level exposure to mercury through fishconsumption in an Italian birth cohort living near a contaminated site. Int J Hyg Environ Health.2013;216(4):486-93. https://www.ncbi.nlm.nih.gov/pubmed/23523155.4. Furlong M, Herring AH, Goldman BD, Daniels JL, Wolff MS, Engel LS, et al. Early LifeCharacteristics and Neurodevelopmental Phenotypes in the Mount Sinai Children’sEnvironmental Health Center. Child Psychiatry Hum Dev. med/29177988.5. Gale CR, Robinson SM, Godfrey KM, Law CM, Schlotz W, O’Callaghan FJ. Oily fish intakeduring pregnancy—association with lower hyperactivity but not with higher full-scale IQ inoffspring. J Child Psychol Psychiatry. bmed/18422546.6. Golding J, Rai D, Gregory S, Ellis G, Emond A Iles-Caven Y, et al. Prenatal mercury exposureand features of autism: a prospective population study. Mol Autism. 3443.7. Hibbeln JR, Davis JM, Steer C, Emmett P, Rogers I, Williams C, et al. Maternal seafoodconsumption in pregnancy and neurodevelopmental outcomes in childhood (ALSPAC study):an observational cohort study. Lancet. /pubmed/17307104.8. Hisada A, Yoshinaga J, Zhang J, Kato T, Shiraishi H, Shimodaira K, et al. Maternal Exposure toPyrethroid Insecticides during Pregnancy and Infant Development at 18 Months of Age. Int JEnviron Res Public Health. 2017;14(1). https://www.ncbi.nlm.nih.gov/pubmed/28075338.9. Hu Y, Chen L, Wang C, Zhou Y, Zhang Y, Wang Y, et al. Prenatal low-level mercury exposureand infant neurodevelopment at 12 months in rural northern China. Environ Sci Pollut Res Int.2016;23(12):12050-9. https://www.ncbi.nlm.nih.gov/pubmed/26965274.10. Julvez J, Mendez M, Fernandez-Barres S, Romaguera D, Vioque J, Llop S, et al. MaternalConsumption of Seafood in Pregnancy and Child Neuropsychological Development: ALongitudinal Study Based on a Population With High Consumption LevelSAm J Epidemiol.2016;183(3):169-82. https://www.ncbi.nlm.nih.gov/pubmed/26740026.11. Lederman SA, Jones RL, Caldwell KL, Rauh V, Sheets SE, Tang D, et al. Relation betweencord blood mercury levels and early child development in a World Trade Center cohort. EnvironHealth Perspect. 2008;116(8):1085-91. https://www.ncbi.nlm.nih.gov/pubmed/18709170.12. Llop S, Guxens M, Murcia M, Lertxundi A Ramon R, Riano I, et al. Prenatal exposure tomercury and infant neurodevelopment in a multicenter cohort in Spain: study of potentialmodifierSAm J Epidemiol. bmed/22287639.13. Mendez MA, Torrent M, Julvez J, Ribas-Fito N, Kogevinas M, Sunyer J. Maternal fish and otherseafood intakes during pregnancy and child neurodevelopment at age 4 yearSPublic HealthNutr. 2009;12(10):1702-10. ion: What is the relationship between seafood consumption during pregnancy and lactation and neurocognitive8development of the infant?

DRAFT – Current as of 10/22/201914. Mesirow MS, Cecil C, Maughan B, Barker ED. Associations between Prenatal and EarlyChildhood Fish and Processed Food Intake, Conduct Problems, and Co-Occurring DifficultieSJAbnorm Child Psychol. 2017;45(5):1039-49. https://www.ncbi.nlm.nih.gov/pubmed/27812905.15. Normia J, Niinivirta-Joutsa K, Isolauri E, Jaaskelainen SK, Laitinen K. Perinatal nutritionimpacts on the functional development of the visual tract in infantSPediatr bmed/30237571.16. Oken E, Radesky JS, Wright RO, Bellinger DC, Amarasiriwardena CJ, Kleinman KP, et al.Maternal fish intake during pregnancy, blood mercury levels, and child cognition at age 3 yearsin a US cohort. Am J Epidemiol. /pubmed/18353804.17. Oken E, Osterdal ML, Gillman MW, Knudsen VK, Halldorsson TI, Strom M, et al. Associationsof maternal fish intake during pregnancy and breastfeeding duration with attainment ofdevelopmental milestones in early childhood: a study from the Danish National Birth Cohort.Am J Clin Nutr. 2008b;88(3):789-96. https://www.ncbi.nlm.nih.gov/pubmed/18779297.18. Oken E, Rifas-Shiman SL, Amarasiriwardena C, Jayawardene I, Bellinger DC, Hibbeln JR, etal. Maternal prenatal fish consumption and cognition in mid childhood: Mercury, fatty acids, andselenium. Neurotoxicol Teratol. 2016;57:71-8. https://www.ncbi.nlm.nih.gov/pubmed/27381635.19. Oken E, Wright RO, Kleinman KP, Bellinger D, Amarasiriwardena CJ, Hu H, et al. Maternal fishconsumption, hair mercury, and infant cognition in a U.SCohort. Environ Health Perspect.2005;113(10):1376-80. https://www.ncbi.nlm.nih.gov/pubmed/16203250.20. Sagiv SK, Thurston SW, Bellinger DC, Amarasiriwardena C, Korrick SA. Prenatal exposure tomercury and fish consumption during pregnancy and attention-deficit/hyperactivity disorderrelated behavior in children. Arch Pediatr Adolesc Med. pubmed/23044994.21. Steenweg-de Graaff J, Tiemeier H, Ghassabian A Rijlaarsdam J, Jaddoe VW, Verhulst FC, etal. Maternal Fatty Acid Status During Pregnancy and Child Autistic Traits: The Generation RStudy. Am J Epidemiol. 2016;183(9):792-9. https://www.ncbi.nlm.nih.gov/pubmed/27052119.22. Valent F, Mariuz M, Bin M, Little D, Mazej D, Tognin V, et al. Associations of prenatal mercuryexposure from maternal fish consumption and polyunsaturated fatty acids with childneurodevelopment: a prospective cohort study in Italy. J Epidemiol. med/23933621.23. Vejrup K, Brandlistuen RE, Brantsaeter AL, Knutsen HK, Caspersen IH, Alexander J, et al.Prenatal mercury exposure, maternal seafood consumption and associations with childlanguage at five yearSEnviron Int. 29089166.24. Williams C, Birch EE, Emmett PM, Northstone K. Stereoacuity at age 3.5 y in children born fullterm is associated with prenatal and postnatal dietary factors: a report from a population-basedcohort study. Am J Clin Nutr. med/11157330.25. Xu Y, Khoury JC, Sucharew H, Dietrich K, Yolton K. Low-level gestational exposure to mercuryand maternal fish consumption: Associations with neurobehavior in early infancy. NeurotoxicolTeratol. 2016;54:61-7. ion: What is the relationship between seafood consumption during pregnancy and lactation and neurocognitive9development of the infant?

DRAFT – Current as of 10/22/2019Excluded ArticlesThe table below lists the articles excluded after full-text screening, and includes columns for the categories of inclusion andexclusion criteria (see Table 1) that studies were excluded based on. At least one reason for exclusion is provided for each article,as indicated by an “X” in one of the columns, though this may not reflect all possible reasons for exclusion. Information aboutarticles excluded after title and abstract screening is available upon request.Table 2. Excluded articles after full-text screening with rationale for exclusionCitation1.2.3.4.Al-Ghannami SS, Al-Adawi S, Ghebremeskel K, HusseinIS, Min Y, Jeyaseelan L, Al-Shammakhi SM, Mabry RM,Al-Oufi HS. Randomized open-label trial ofdocosahexaenoic acid-enriched fish oil and fish meal oncognitive and behavioral functioning in Omani children.Nutrition. 2019;57,167-172.Andrew MJ, Parr JR, Montague-Johnson C, Laler K, QiC, Baker B, Sullivan PB. Nutritional intervention andneurodevelopmental outcome in infants with suspectedcerebral palsy: the Dolphin infant double-blindrandomized controlled trial. Dev Med Child Neurol.2018;60,906-913.Boucher O, Muckle G, Ayotte, P, Dewailly, E, JacobsonSW, Jacobson JL. Altered fine motor function at schoolage in Inuit children exposed to PCBs, methylmercury,and lead. Environ Int. 2016;95,144-51.Braarud HC, Markhus MW, Skotheim S, Stormark KM,Froyland L, Graff IE, Kjellevold M. Maternal DHA Statusduring Pregnancy Has a Positive Impact on InfantProblem Solving: A Norwegian Prospective ObservationStudy. eStudyDesignComparatorXXXXQuestion: What is the relationship between seafood consumption during pregnancy and lactation and neurocognitive development of the infant?10

DRAFT – Current as of rouwer-Brolsma EM, van de Rest O, Godschalk R,Zeegers MPA, Gielen M, de Groot RHM. Associationsbetween maternal long-chain polyunsaturated fatty acidconcentrations and child cognition at 7 years of age: TheMEFAB birth cohort. Prostaglandins Leukot Essent FattyAcids. 2017;126,92-97.Budtz-Jorgensen E, Grandjean P, Weihe P. Separationof risks and benefits of seafood intake. Environ HealthPerspect. 2007;115,323-7Chen MYY, Wong, WWK, Chung SWC, Tran CH, ChanBTP, Ho

Publication status Articles that have been peer-reviewed Articles that have not been peer-reviewed and are not published in peer -reviewed journals, including unpublished data manuscripts, reports, abstracts, and conference proceedings Language of publication Articles published in English Articles published in languages other than English

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