[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06420531":3,"trial-entities:NCT06420531":182,"trial-summary:NCT06420531":186},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":41,"sex":97,"minimum_age":98,"maximum_age":99,"healthy_volunteers":100,"eligibility_criteria":101,"std_ages":115,"locations":117,"central_contacts":175,"overall_officials":177,"references":180,"see_also_links":181},"NCT06420531","IRB-300013026","Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial","A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm","RECRUITING","2030-08-30","2026-06","2026-06-15","2025-09-16","University of Alabama at Birmingham","OTHER",true,"The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL\u002Fkg\u002Fday on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.","Participants will be randomized once they reach 120 mL\u002Fkg\u002Fday. Clinicians will be able to increase feeds each day as they see fit, until the patient reaches the target goal of 140-160 mL\u002Fkg\u002Fday or 180-200 mL\u002Fkg\u002Fday. They will then maintain this volume until 34 weeks postmenstrual age. Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes.\n\nParticipants will:\n\n* Have a feeding volume of 180-200 mL\u002Fkg\u002Fday or a volume of 140-160 mL\u002Fkg\u002Fday until 34 weeks corrected age\n* Have four body composition assessments with a bioelectrical impedance analyzer throughout study period\n* Have four stool samples collected throughout study period\n* Have four maternal breastmilk samples collected and analyzed throughout the study period\n* Have one blood sample collected at 36 weeks corrected age\n* Have the option to participate in a follow-up survey completed by parents at 2-3 years of age",[19],"Prematurity",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},486,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIETARY_SUPPLEMENT","Human milk","maternal breastmilk or donor breastmilk",[34,35],"Control:140-160 mL\u002Fkg\u002Fday of human milk","Intervention: 180-200 mL\u002Fkg\u002Fday of human milk",[37],{"measure":38,"description":39,"timeFrame":40},"Fat-free Mass (FFM)-For-age-Z-score","Estimated by bioelectric impedance analysis. FFM measurements will be converted into Z-scores using updated, sex specific reference curves of body composition in preterm infants","36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer",[42,46,49,52,56,60,64,68,72,75,79,82,86,89,93],{"measure":43,"description":44,"timeFrame":45},"Body fat percentage","Estimated by bioelectric impedance analysis. Body fat measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.","Birth to 36 weeks postmenstrual age",{"measure":47,"description":48,"timeFrame":45},"Anthropometric Measurements","Weight, length, head circumference, and mid-upper arm circumference measurements. Measurements will be converted into Z-scores based on Fenton growth curves (2013).",{"measure":50,"description":51,"timeFrame":40},"Bronchopulmonary Dysplasia","Number of participants receiving supplemental oxygen at 36 weeks (PMA)",{"measure":53,"description":54,"timeFrame":55},"Number of Days Alive and Receiving Full Enteral Feeding","Time to full enteral feeding days","Birth to 28 days",{"measure":57,"description":58,"timeFrame":59},"Duration of Hospital Stay in Days","From day of admission to day of hospital discharge to home","Birth to 120 days or discharge, whichever occurs first",{"measure":61,"description":62,"timeFrame":63},"Growth Rate","Weight gain in g\u002Fkg\u002Fday","Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).",{"measure":65,"description":66,"timeFrame":67},"Number of Participants with Postnatal Faltering Growth","Diagnosis of faltering growth (weight z score decline from birth to 36 weeks \\> 1) using the 2013 Fenton growth curve.","36 weeks or hospital discharge (whichever occurs first)",{"measure":69,"description":70,"timeFrame":71},"Number of Participants diagnosed with Necrotizing Enterocolitis","Diagnosis of necrotizing enterocolitis stage 2 or 3","From birth up to 120 days following birth",{"measure":73,"description":74,"timeFrame":71},"Number of Participants with Diagnosis of Intestinal Perforation","Diagnosis of intestinal perforation",{"measure":76,"description":77,"timeFrame":78},"Death","Death prior to 121 days of life","Birth to 120 days",{"measure":80,"description":81,"timeFrame":78},"Culture-proven Sepsis","Diagnosis of sepsis with positive blood cultures",{"measure":83,"description":84,"timeFrame":85},"Fat Mass (FM)- For age Z-score","Estimated by bioelectric impedance analysis. FM measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.","36 weeks or hospital discharge, up to 120 days following birth, whichever is longer",{"measure":87,"description":88,"timeFrame":40},"Body Fat (BF)-For age Z-score","Estimated by bioelectric impedance analysis. BF measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.",{"measure":90,"description":91,"timeFrame":92},"Duration of parenteral nutrition","Number of days receiving parenteral nutrition","Birth to 28 days of life",{"measure":94,"description":95,"timeFrame":96},"Post discharge growth outcomes","Weight, length, and head circumference measurements. Measurements will be converted into Z-scores.","22-26 months corrected age","ALL","6 Hours","4 Days",false,{"inclusion":102,"exclusion":107,"raw_text":114},[103,104,105,106],"Gestational age between 27 0\u002F7 and 31 6\u002F7 weeks","Birthweight of 1500 grams or less","Human milk feeding during the first 14 days after birth","Full enteral feeding (120mL\u002Fkg\u002Fday or more) within the first 14 days after birth",[108,109,110,111,112,113],"Necrotizing enterocolitis stage 2 or greater","Spontaneous intestinal perforation","Major congenital\u002Fchromosomal anomalies","Terminal illness requiring limited or withheld support","Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA)","Any formula feeding within the first 14 days after birth","Inclusion Criteria:\n\n* Gestational age between 27 0\u002F7 and 31 6\u002F7 weeks\n* Birthweight of 1500 grams or less\n* Human milk feeding during the first 14 days after birth\n* Full enteral feeding (120mL\u002Fkg\u002Fday or more) within the first 14 days after birth\n\nExclusion Criteria:\n\n* Necrotizing enterocolitis stage 2 or greater\n* Spontaneous intestinal perforation\n* Major congenital\u002Fchromosomal anomalies\n* Terminal illness requiring limited or withheld support\n* Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA)\n* Any formula feeding within the first 14 days after birth",[116],"CHILD",[118,132,148,162],{"facility":13,"status":8,"city":119,"state":120,"zip":121,"country":122,"contacts":123,"geoPoint":129},"Birmingham","Alabama","35294","United States",[124],{"name":125,"role":126,"phone":127,"email":128},"Ariel A. Salas, MD, MSPH","CONTACT","205-934-4680","asalas@uab.edu",{"lat":130,"lon":131},33.52066,-86.80249,{"facility":133,"status":134,"city":135,"state":136,"zip":137,"country":122,"contacts":138,"geoPoint":145},"University of Mississippi Medical Center","NOT_YET_RECRUITING","Jackson","Mississippi","39216",[139,143],{"name":140,"role":126,"phone":141,"email":142},"Simon Karam, MD","601-815-3464","skaram@umc.edu",{"name":140,"role":144},"PRINCIPAL_INVESTIGATOR",{"lat":146,"lon":147},32.29876,-90.18481,{"facility":149,"status":134,"city":150,"state":151,"zip":152,"country":122,"contacts":153,"geoPoint":159},"University of Texas Southwestern Medical Center at Dallas","Dallas","Texas","75235",[154,158],{"name":155,"role":126,"phone":156,"email":157},"Eric Ortigoza, MD, MSCR","214-648-3903","Eric.Ortigoza@UTSouthwestern.edu",{"name":155,"role":144},{"lat":160,"lon":161},32.78306,-96.80667,{"facility":163,"status":134,"city":164,"state":151,"zip":165,"country":122,"contacts":166,"geoPoint":172},"University of Texas Health Science Center at Houston","Houston","77030",[167,171],{"name":168,"role":126,"phone":169,"email":170},"Mar Romero-Lopez, MD, PhD","713-500-7283","Maria.del.Mar.RomeroLopez@uth.tmc.edu",{"name":168,"role":144},{"lat":173,"lon":174},29.76328,-95.36327,[176],{"name":125,"role":126,"phone":127,"email":128},[178],{"name":125,"affiliation":179,"role":144},"UAB Hospital",[],[],{"nct_id":4,"conditions":183,"biomarkers":185},[184],"Preterm Birth",[],{"nct_id":4,"found":15,"summary":187,"prompt_version":197},{"design":188,"status":189,"heading":190,"summary":191,"follow_up":192,"word_count":193,"commitments":194,"compensation":195,"drugs_mentioned":196},"This is a randomized study, meaning participants are assigned by chance to one of two feeding groups. It plans to enroll 486 participants.","completed","MAGIC Trial: Human Milk and Growth in Very Preterm Infants","This study, called MAGIC (Milk And Growth In Children), is looking at how different amounts of human milk feeding affect the growth of very preterm infants (babies born between 27 and 31 weeks of pregnancy). Researchers want to see if feeding 180-200 mL\u002Fkg\u002Fday of human milk (either from the mother or a donor) helps babies gain more fat-free mass (muscle and bone) compared to feeding 140-160 mL\u002Fkg\u002Fday. They will measure this at 36 weeks post menstrual age (the age the baby would be if born at full term) or when the baby leaves the hospital. To join, babies must be 6 hours to 4 days old, born between 27 and 31 weeks of pregnancy, weigh 1500 grams or less at birth, and be able to drink human milk. The study is currently unclear on its recruitment status.","Parents have the option to complete a follow-up survey when their child is 2-3 years old.",137,"Participants will receive one of two human milk feeding volumes until 34 weeks corrected age. They will have four body composition assessments, four stool samples collected, four maternal breastmilk samples collected, and one blood sample collected.","Not stated in the trial record.",[31],"v2"]