[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639874":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":56,"collaborators":58,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":95,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Mother's Milk is Best","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HMC-Concentrated MOM","EXPERIMENTAL","Preterm infants receive enteral feedings of mother's own milk that has been concentrated using the HMC device to increase nutrient density without the addition of bovine-derived fortifiers.",[13],"Device: Human Milk Concentration Device",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Fortified Feeding (MOM + Fortifier\u002FFormula)","ACTIVE_COMPARATOR","Preterm infants receive enteral feedings of mother's own milk supplemented with cow's milk-based fortifier or formula according to institutional standard of care.",[19],"Other: Standard of Care Fortified Feeding",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Human Milk Concentration Device","A sterile, single-use human milk concentration device used to passively remove water from mother's own milk prior to feeding, increasing nutrient density without the addition of bovine-derived fortifier.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Standard of Care Fortified Feeding","Mother's own milk supplemented with cow's milk-based human milk fortifier and\u002For formula according to institutional standard of care.",[15],[33],{"name":34,"affiliation":35,"role":36},"Sarah Taylor, MD","Yale University","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Elizabeth Nelson, PhD","CONTACT","2679818066","enelson@mmib.health",[44],{"facility":35,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":26},"New Haven","Connecticut","06511","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-72.92816,41.30815,{"lat":54,"lon":53},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[59,62,64,66],{"name":60,"class":61},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":63,"class":28},"Beth Israel Deaconess Medical Center",{"name":65,"class":28},"Weill Medical College of Cornell University",{"name":35,"class":28},"100639874","human-milk-concentrating-device-to-optimize-mothers-own-milk-100639874",false,"NCT07576972","Human Milk Concentrating Device to Optimize Mother's Own Milk","Noninferiority Evaluation of Human Milk Concentrating Device to Optimize Mother's Own Milk","NEOMOM","Inclusion Criteria:\n\n* Birth at 32 0\u002F7 to 34 5\u002F7 weeks' gestational age, with a birthweight above 1500 grams and receiving MOM\n* Enteral feeding must be initiated within 48 hours post-birth and the infant must meet the NICU's clinical guidelines for feed fortification\u002Fsupplementation.\n* Multiples are eligible and will be randomized to the same group since the intervention affects MOM preparation.\n\nExclusion Criteria:\n\n* Major congenital anomalies\n* Contraindication to receiving MOM\n* Feeds not started by 2 days post-birth\n* Fortification\u002Fsupplementation not ordered by 5 days post-birth,\n* Inadequate MOM for concentration\u002Ffortification within 5 days post-birth\n* Expected transfer to another hospital\n* Expected hospital discharge within 14 days post-birth\n* Enrollment in another intervention study with an intervention that could affect infant growth or mineral status\n* Infant with contraindications for use of the HMC device","ALL","32 Weeks","35 Weeks",{"count":79,"type":80},310,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants. The trial compares outcomes in infants fed mother's own milk (MOM) concentrated using the HMC device to those receiving standard of care feeding with MOM supplemented with cow's milk-based fortifiers or formula.\n\nThe primary objective is to determine whether infants receiving HMC-concentrated MOM achieve growth and mineral status that are non-inferior to standard of care, as measured by growth velocity through 28 days of life or hospital discharge and serum phosphate levels at 14 days of life.\n\nSecondary objectives include assessment of clinical safety through evaluation of feeding tolerance, weight gain, and serum chemistries during the study period. The study will also evaluate the cost and resource utilization associated with feeding strategies by comparing preparation time, supply costs, total feeding costs, and overall neonatal intensive care unit (NICU) cost of care, including length of stay.",[86,87],"Preterm Infant Health","Premature Babies",[89,90,91,92,93,94],"Human Milk Concentration","NICU Feeding","Neonatal nutrition","Mother's on Milk","Human Milk","Preterm infants","NOT_YET_RECRUITING","2026-05-04",{"date":98,"type":99},"2026-05-08","ACTUAL",{"date":101,"type":80},"2026-09-01",{"date":103,"type":80},"2028-07-01",{"name":5,"class":6},1]