[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574944":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":109,"collaborators":112,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":136,"minAge":44,"maxAge":137,"enrollmentInfo":138,"targetDuration":44,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":52,"whyStopped":44,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Harvard School of Public Health (HSPH)","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Routine fortification of human milk with human milk fortifier using a standardized clinical protocol","EXPERIMENTAL","Enrolled participants in the intervention arm will be exposed to:\n\n* Provision of guideline-driven standard of care specifically for VPT\u002F VLBW babies\n* Encouragement to express breast milk with breast pumps\n* Adherence to a clinical guideline including targets for initiation and advancement of breast milk feeding for VPT\u002F VLBW babies based on birthweight\n* Fortification of human milk with HMF\n* Adherence to standardized stopping criteria (i.e., stopping adherence to clinical feeding guideline AND stopping routine fortification of human milk)",[13,14],"Dietary Supplement: Human Milk Fortifier","Other: Volume targets",{"label":16,"type":17,"description":18,"interventionNames":19},"No routine fortification of human milk using a standardized clinical protocol","ACTIVE_COMPARATOR","Participants in the control group will have the same exposures as the participants in the intervention group EXCEPT for the human milk consumed will not be fortified with HMF.\n\n* Provision of guideline-driven standard of care specifically for VPT\u002F VLBW babies\n* Encouragement to express with breast pumps\n* Adherence to a clinical guideline including targets for initiation and advancement of breast milk feeding for VPT\u002F VLBW babies based on birthweight\n* Adherence to standardized stopping criteria (i.e., stopping adherence to clinical feeding guideline)",[14],[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Human Milk Fortifier","Human milk fortifier added to expressed human milk (mother's own milk or pasteurized donor human milk) per feed per manufacturer's instructions for a minimum of 21 days (in-facility provision only)\n\n* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding\n* Provision of guideline-driven standard of care \\[facility-based lactation support\u002Ffeeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\\]",[9],[27,28],"Volume targets","Guideline-driven standard of care",{"type":6,"name":27,"description":30,"armGroupLabels":31,"otherNames":32},"* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding\n* Provision of guideline-driven standard of care \\[facility-based lactation support\u002Ffeeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\\]",[16,9],[33],"Guideline driven standard of care",[35],{"name":36,"affiliation":37,"role":38},"Katherine Semrau, PhD, MPH","Ariadne Labs | Harvard TH Chan School of Public Health and Brigham and Womens Hospital","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Ilana Dzuba, MHS","CONTACT","617-384-6555",null,"idzuba@ariadnelabs.org",{"name":47,"role":42,"phone":44,"phoneExt":44,"email":48},"Linda Vesel, PhD, MPH","lvesel@ariadnelabs.org",[50,66,84,95],{"facility":51,"status":52,"city":53,"state":54,"zip":44,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Ballari Medical College and Research Centre","RECRUITING","Ballary","Karnataka","India","IN",{"type":58,"coordinates":59},"Point",[60,61],76.28826,15.46082,{"lat":61,"lon":60},[64],{"name":65,"role":42,"phone":44,"phoneExt":44,"email":44},"Durgappa, MD",{"facility":67,"status":68,"city":69,"state":54,"zip":44,"country":55,"countryCode":56,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"KLES Dr Prabhakar Kore Hospital & Medical Research Center","NOT_YET_RECRUITING","Belagavi",{"type":58,"coordinates":71},[72,73],74.50447,15.85212,{"lat":73,"lon":72},[76,78,79,82],{"name":77,"role":42,"phone":44,"phoneExt":44,"email":44},"Roopa Bellad, MD",{"name":77,"role":38,"phone":44,"phoneExt":44,"email":44},{"name":80,"role":81,"phone":44,"phoneExt":44,"email":44},"Sunil S Vernekar","SUB_INVESTIGATOR",{"name":83,"role":81,"phone":44,"phoneExt":44,"email":44},"S M Dhaded",{"facility":85,"status":52,"city":86,"state":54,"zip":44,"country":55,"countryCode":56,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"JJM Medical College","Davangere",{"type":58,"coordinates":88},[89,90],75.92694,14.46693,{"lat":90,"lon":89},[93],{"name":94,"role":42,"phone":44,"phoneExt":44,"email":44},"Gowdar Guruprasad, MD, DCH, DNB, DM",{"facility":96,"status":52,"city":97,"state":98,"zip":44,"country":55,"countryCode":56,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Niloufer Hospital","Hyderabad","Telangana",{"type":58,"coordinates":100},[101,102],78.45636,17.38405,{"lat":102,"lon":101},[105],{"name":106,"role":42,"phone":107,"phoneExt":44,"email":108},"Swapna Lingaldinna, MBBS","+91 98480 82441","drswapnalingadinna@gmail.com",{"type":38,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Katherine Semrau","Deputy Director, Ariadne Labs & Director, BetterBirth Program; Associate Professor, HSPH",[113,115,117,119,121,123,125],{"name":114,"class":6},"Boston Children's Hospital",{"name":116,"class":6},"Brigham and Women's Hospital",{"name":118,"class":6},"Emory University",{"name":120,"class":6},"Muhimbili University of Health and Allied Sciences",{"name":122,"class":6},"Jawaharlal Nehru Medical College",{"name":124,"class":6},"PATH",{"name":126,"class":6},"University of North Carolina","100574944","lift-up-randomized-controlled-trial-of-fortification-of-human-milk-100574944",false,"NCT06765863","LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk","Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Randomized Controlled Trial of In-facility Fortification of Human Milk in India","LIFT-UP RCT","Inclusion Criteria:\n\n* Very LBW (≤1.5kg)\\* or very preterm (≤32 weeks) infants admitted to NICU at study facility within 24 hours of birth for in-born infants and up to 48 hours for out-born\\*\\*\n* Mother and infant alive during screening\n* Mother age 18+ years\n* Lives within catchment areas of the facility\n* Mother intends to stay in catchment area of the study facility for at least 3 months\n* At randomization: Infant receiving at least 60 mL\u002Fkg\u002Fday of human milk\\*\\*\\*\n\nExclusion Criteria:\n\n* Lives outside the defined catchment area\n* Congenital abnormalities or acquired conditions that interfere with feeding or placement of nasogastric\u002Forogastric tube \\[cleft lip\u002Fpalate, toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, congenital cardiac defect, neural tube defect, gastrointestinal tract anomalies, hydrocephalus, NEC\\]\n* Severe birth asphyxia\n* Critically ill (i.e. not on enteral feeds)\n* Unknown date of birth and unknown gestational age",true,"ALL","48 Hours",{"count":139,"type":140},776,"ESTIMATED","INTERVENTIONAL",[143],"NA","The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol.\n\nThe primary research question is: Will VLBW or VPT infants in the NICU who are fed fortified human milk using a standardized feeding protocol have better growth outcomes by facility discharge and at 3 months of age, less illness by discharge, and decreased mortality by discharge and at one month compared to those who are not routinely fed fortified human milk using the same feeding protocol?",[146,147],"Very Preterm Infant","Very Low Birthweight",[149,150,151,152],"very preterm","very low birthweight","fortification","human milk","2026-01-16",{"date":155,"type":156},"2026-01-21","ACTUAL",{"date":158,"type":156},"2025-01-16",{"date":160,"type":140},"2027-03-31",{"name":5,"class":6},4]