[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524377":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":36,"responsibleParty":56,"collaborators":58,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":10,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Johns Hopkins Bloomberg School of Public Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"City Mother-Infant Pairs",null,"Mother-infant pairs living in a Baltimore City, Maryland zip code exposed to micro and nano plastics.",[13],"Other: Observational only",{"label":15,"type":10,"description":16,"interventionNames":17},"County Mother-Infant Pairs","Mother-infant pairs living in a Baltimore County, Maryland zip code exposed to micro and nano plastics.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Observational only","Exposure to micro and nano plastics",[9,15],[24],{"name":25,"affiliation":5,"role":26},"Tanya L Alderete, PhD","PRINCIPAL_INVESTIGATOR",[28,32],{"name":25,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","303-735-6249","tanya.alderete@colorado.edu",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Charlotte Haslett","7813256585","chha5255@colorado.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"East Baltimore Pediatric Inpatient and Outpatient Clinical Research Unit","RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-76.61219,39.29038,{"lat":49,"lon":48},[52],{"name":53,"role":29,"phone":54,"phoneExt":10,"email":55},"Rachel Salamone, RN","410-614-6365","rsalamo3@jhu.edu",{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[59,61],{"name":60,"class":6},"Emory University",{"name":62,"class":63},"Sonoma Technology, Inc.","UNKNOWN","100524377","developmental-impacts-of-microplastics-exposure-in-early-life-100524377",false,"NCT06107933","Developmental Impacts of Microplastics Exposure in Early Life","Developmental Impacts of MicroPLastics Exposure in Early Life","DIMPLE","Inclusion Criteria:\n\n* All gender expressions\n* Mothers at 1 or 3 months postpartum (± 2 weeks)\n* Intent to exclusively breastfeed for ≥ 6 months\n* Nulliparous and singleton births\n* Receiving only breast milk from the mother, with no formula supplementation\n\nExclusion Criteria:\n\n* Physical, mental, or cognitive disability that prevents participation; current incarceration\n* Chronic conditions in mother and\u002For infant (e.g., heart disease, cancer, autoimmune disease, diabetes, intestinal bowel syndrome\u002Fdisease), conditions diagnosed for the first time during pregnancy (e.g. gestational diabetes), neurological conditions in mother and\u002For infant (e.g. epilepsy, seizures), psychological conditions in mother and\u002For infant (e.g. bipolar disorder), or neurological\u002Fpsychological conditions diagnosed in mother during or immediately after pregnancy (e.g. postpartum depression)\n* Previously diagnosed with any major illness (e.g., intrauterine growth restriction, birth asphyxia, cancer) or eating disorder or previous gastric band surgery\n* Maternal antibiotic use during pregnancy or the postpartum period. Infant antibiotic use at any time during life or taking medications that could affect plastic exposure or the microbiome, such as medications administered via a plastic syringe.\n* Use of any breast pump except the Silicon Breast Pump for the 14 days prior to the clinical visit.\n* PHQ9 score greater than or equal to 10 indicating clinically relevant symptoms of moderate or worse depression\n* Infants who are intersex\n* Smoking, drug use (including marijuana use), or alcohol abuse",true,"FEMALE","18 Years",{"count":76,"type":77},40,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to characterize and evaluate micro- and nano-plastic (MNP) exposures among mothers and infants in mother-infant dyads 1 or 3 months postpartum living in Baltimore, Maryland. The main questions it aims to answer are:\n\n* What MNPs are present in breastmilk and maternal blood samples and in their infants stool sample?\n* Are there associations between amount of maternal MNPs in breast milk and mass of MNP particles in infant stool?\n* Which environmental and lifestyle factors are most predictive of maternal MNP burden?\n* Is infant exposure to MNPs associated with birth weight and postnatal growth trajectories?\n\nParticipants will:\n\n* Complete several questionnaires assessing medical histories, lifestyle factors, environmental exposures, eating behaviors, etc.\n* Provide biological specimens including: maternal blood, stool, and breastmilk; infant stool\n* Clinical visit to have anthropometric measures documented including maternal height and weight, infant weight, length, and skin-fold thickness",[81,82,83],"Infant Development","Breast Feeding","Environmental Exposure",[85,86,87,88,89],"microplastic","breastmilk","infant microplastic exposure","gut microbiome","fecal metabolome","2026-06-05",{"date":92,"type":93},"2026-06-09","ACTUAL",{"date":95,"type":93},"2023-10-01",{"date":97,"type":77},"2027-01-01",{"name":5,"class":6},1]