[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609598":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":65,"collaborators":67,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":18,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Loyola University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"M-MILK Group","EXPERIMENTAL","Infants in the M-MILK group will receive M-MILK intervention and standard of care. M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their oral caloric intake. M-MILK is provided by research nurses or parents.",[13],"Other: Multisensory early oral administration of human milk",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Infants in the Control group will receive standard of care.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Multisensory early oral administration of human milk","M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their oral caloric intake. M-MILK is provided by research nurses or parents.",[9],[25],"M-MILK",[27],{"name":28,"affiliation":29,"role":30},"Thao Griffith, PhD","Loyola University Chicago","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","464-220-9825","tgriffith1@luc.edu",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Cara Joyce, PhD","464-220-9521","cjoyce6@luc.edu",[41,58],{"facility":29,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Maywood","Illinois","60153","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-87.84312,41.8792,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":57,"phoneExt":18,"email":35},"Thao Griffith","4642209825",{"facility":59,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Loyola University Medical Center",{"type":49,"coordinates":61},[51,52],{"lat":52,"lon":51},[64],{"name":56,"role":33,"phone":57,"phoneExt":18,"email":35},{"type":66,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[68,71],{"name":69,"class":70},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":72,"class":6},"Rush University Medical Center","100609598","multisensory-early-oral-administration-of-human-milk-m-milk-for-very-preterm-infants-100609598",false,"NCT07216664","Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants","Randomized Controlled Trial of Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants: Enhancing Stress Regulation, Neurodevelopment, and Oral Feeding Skills","M-MILK RCT","Inclusion Criteria:\n\n* Born at ≤ 32 weeks gestational age.\n* Receiving mother's own milk and\u002For donor human milk at the time of screening.\n\nExclusion Criteria:\n\n* Receiving only formula.\n* Gastrointestinal defects, i.e., cleft lip or cleft palate.\n* Congenital cardiac defects requiring surgery.\n* Necrotizing enterocolitis.\n* Chromosomal abnormalities.","ALL","23 Weeks","32 Weeks",{"count":85,"type":86},125,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants). The main question that this clinical trial aims to answer is: Does M-MILK improve stress regulation, support optimal neurodevelopment, and promote competent oral feeding skills in very preterm infants?\n\nResearchers will compare M-MILK to the standard of care to see if M-MILK helps very preterm infants. Specifically, researchers will compare the differences in:\n\n* Cortisol levels\n* DNA methylation of the two stress related genes (NR3C1 and HSD11B2)\n* Neurodevelopment\n* Oral feeding skills Participants in the M-MILK group will receive standard of care plus M-MILK intervention, which starts on day 3 of life and continues until they begin their oral feeding. M-MILK will be provided by clinical research nurses, during the day shift, up to 4 times a day. Participants in the standard of care group will continue to receive their usual care.",[92],"Infant, Premature, Diseases","2026-01-16",{"date":95,"type":96},"2026-01-20","ACTUAL",{"date":98,"type":96},"2025-11-03",{"date":100,"type":86},"2031-05-31",{"name":5,"class":6},2]