[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583027":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":22,"locations":33,"responsibleParty":108,"collaborators":111,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":126,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":10,"studyType":138,"phases":10,"briefSummary":139,"conditions":140,"keywords":149,"overallStatus":71,"whyStopped":10,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants of the MaxiMoM Platform Trials",null,"Secondary data use and biospecimens from participants of the MaxiMoM Platform Trials are infants born 1500g or less (infant weight), born in the Greater Toronto Area.",[13],"Other: Opti-NuM is an observational secondary use of data\u002Fsamples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.",[15],{"type":6,"name":16,"description":10,"armGroupLabels":17,"otherNames":10},"Opti-NuM is an observational secondary use of data\u002Fsamples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.",[9],[19],{"name":20,"affiliation":5,"role":21},"Deborah L O'Connor, PhD, RN","PRINCIPAL_INVESTIGATOR",[23,29],{"name":24,"role":25,"phone":26,"phoneExt":27,"email":28},"Dubraiicka Pichardo, MSc","CONTACT","416-813-7654","305777","dubraiicka.pichardo@sickkids.ca",{"name":30,"role":25,"phone":31,"phoneExt":10,"email":32},"Aneta Plaga, BSc","416-978-2422","aneta.plaga@utoronto.ca",[34,48,57,69,89,94],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"Stanford University","ACTIVE_NOT_RECRUITING","Palo Alto","California","94304-1212","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-122.14302,37.44188,{"lat":46,"lon":45},{"facility":49,"status":36,"city":50,"state":38,"zip":51,"country":40,"countryCode":41,"cosmosGeoPoint":52,"geoPoint":56,"contacts":10},"University of California - San Diego","San Diego","92093-0715",{"type":43,"coordinates":53},[54,55],-117.16472,32.71571,{"lat":55,"lon":54},{"facility":58,"status":36,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":10},"University of Manitoba","Winnipeg","Manitoba","R3E 3P4","Canada","CA",{"type":43,"coordinates":65},[66,67],-97.14704,49.8844,{"lat":67,"lon":66},{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":62,"countryCode":63,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Sunnybrook Health Sciences Centre","RECRUITING","Toronto","Ontario","M4N 3M5",{"type":43,"coordinates":76},[77,78],-79.39864,43.70643,{"lat":78,"lon":77},[81,86,87],{"name":82,"role":25,"phone":83,"phoneExt":84,"email":85},"Eugene Ng, MD, FRCPC","416-480-6100","87781","eugene.ng@sunnybrook.ca",{"name":24,"role":25,"phone":26,"phoneExt":27,"email":28},{"name":88,"role":21,"phone":10,"phoneExt":10,"email":10},"Eugene Ng, MD, FRCPC, FAAP",{"facility":5,"status":36,"city":72,"state":73,"zip":90,"country":62,"countryCode":63,"cosmosGeoPoint":91,"geoPoint":93,"contacts":10},"M5G 0A4",{"type":43,"coordinates":92},[77,78],{"lat":78,"lon":77},{"facility":95,"status":71,"city":72,"state":73,"zip":96,"country":62,"countryCode":63,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Mount Sinai Hospital","M5G 1X5",{"type":43,"coordinates":98},[77,78],{"lat":78,"lon":77},[101,105,107],{"name":102,"role":25,"phone":103,"phoneExt":10,"email":104},"Sharon L Unger, MD","416-586-8593","Sharon.Unger@sinaihealth.ca",{"name":24,"role":25,"phone":106,"phoneExt":27,"email":28},"4168137654",{"name":102,"role":21,"phone":10,"phoneExt":10,"email":10},{"type":21,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Deborah O'Connor","Senior Associate Scientist",[112,114,115,117,118,119,121],{"name":113,"class":6},"Mount Sinai Hospital, Canada",{"name":70,"class":6},{"name":116,"class":6},"University of Toronto",{"name":58,"class":6},{"name":35,"class":6},{"name":120,"class":6},"University of California, San Diego",{"name":122,"class":123},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100583027","optimizing-nutrition-and-milk-opti-num-project-100583027",false,"NCT06870981","Optimizing Nutrition and Milk (Opti-NuM) Project","Improving Growth and Neurodevelopment of Very Low Birth Weight Infants Through Precision Nutrition: The Optimizing Nutrition and Milk (Opti-NuM) Project","Opti-NuM","Inclusion Criteria:\n\n• Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs\n\nExclusion Criteria:\n\n• Data and biospecimens from infants who are not enrolled in the three trials are eligible for this project.","ALL","1 Hour","21 Days",{"count":136,"type":137},1100,"ESTIMATED","OBSERVATIONAL","Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants. There is increasing interest in \"precision nutrition\" approaches, but it is unclear which Human Milk (HM) components require personalized adjustment of doses. Previous efforts have focused on macronutrients, but HM also contains essential micronutrients as well as non-nutrient bioactive components that shape the gut microbiome. Further, it is unclear if or how parental factors (e.g. body mass index, diet) and infant factors (e.g. genetics, gut microbiota, sex, acuity) influence relationships between early nutrition and growth, neurodevelopment and morbidity. Understanding these complex relationships is paramount to developing effective personalized HM feeding strategies for VLBW infants. This is the overarching goal of the proposed Optimizing Nutrition and Milk (Opti-NuM) Project.\n\nThe Opti-NuM Project brings together two established research platforms with complementary expertise and resources: 1) the MaxiMoM Program\\* with its clinically embedded translational neonatal feeding trial network in Toronto (Dr. Deborah O'Connor, Dr. Sharon Unger) and 2) the International Milk Composition (IMiC) Consortium, a world-renowned multidisciplinary network of HM researchers and data scientists collaborating to understand how the myriad of HM components contribute \"as a whole\" to infant growth and development, using systems biology and machine learning approaches. Members of the IMiC Corsortium that will work with on this study are located at the University of Manitoba (Dr. Meghan Azad), University of California (Dr. Lars Bode) and Stanford (Dr. Nima Aghaeepour).",[141,142,143,144,145,146,147,148],"Very Low Birth Weight Baby","Early Nutrition and the Preterm Infant","Nutritional Requirements","Human Milk Fortification","Human Milk Microbiome","Human Milk Feeding","Human Milk Nutrition","Growth &Amp; Development",[150,151,152],"Very Low Birth Weight Infants","Early nutrition and the preterm infant","Human milk feeding","2025-03-06",{"date":155,"type":156},"2025-03-11","ACTUAL",{"date":158,"type":156},"2010-10-01",{"date":160,"type":137},"2027-12",{"name":5,"class":6},6]