[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07702318":3,"trial-entities:NCT07702318":89,"trial-summary:NCT07702318":93},{"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":24,"primary_purpose":17,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":51,"sex":52,"minimum_age":17,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":64,"locations":66,"central_contacts":76,"overall_officials":77,"references":83,"see_also_links":88},"NCT07702318","20102003","Early Childhood (2-year) Outcomes Among Former VLBW From the ReDiMOM Trial","Early Childhood Neurodevelopmental, Economic and Nutritional Outcomes Among Former Very Low Birth Weight Infants From the Reducing Disparity in Mother's Own Milk (ReDiMOM) Trial","ENROLLING_BY_INVITATION","2027-05-31","2026-07","2026-07-14","2022-09-23","Rush University Medical Center","OTHER",false,"The goal of this study is to determine the long-term outcomes associated with an economic intervention that was provided to encourage mother's of very premature infants to provide mother's own milk. This study will follow children after they are discharged from the Neonatal Intensive Care Unit, where their mothers received the economic intervention, out to age 2 years. This study will examine childhood outcomes at 2 years of age based on which group the mothers had been randomized into. This study will also determine the relationship between the total duration mother's own milk was received during the first year of life and early childhood outcomes at age 2 years in infants that were born very premature.",null,[19],"Preterm",[21,22,23],"milk","very preterm","economic intervention","OBSERVATIONAL",[],{"count":27,"type":28},275,"ESTIMATED",[],[31,35,38,42,45,48],{"measure":32,"description":33,"timeFrame":34},"Cognition","Cognitive index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.","2 years",{"measure":36,"description":37,"timeFrame":34},"Adiposity","Adiposity measured by BIA",{"measure":39,"description":40,"timeFrame":41},"MOM duration","Duration of partial and\u002For exclusive MOM feedings through the first year of life using questionnaire.","1 year",{"measure":43,"description":44,"timeFrame":34},"Total costs","Total costs at 20 months CA will be determined from the societal perspective and defined as the sum of ReDiMOM intervention, healthcare, EI and associated family costs from birth to 20 months CA. Detailed intervention costs for each infant are already collected for the original ReDiMOM RCT. Healthcare costs will be obtained from 5 sources: 1) ReDiMOM RCT prospective database, 2) self-report questionnaire to assess family healthcare costs, 3) Medicaid claims, 4) Illinois State Early Intervention Database, and 5) RUMC system-wide cost-account and billing systems",{"measure":46,"description":47,"timeFrame":34},"Language","Language index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.",{"measure":49,"description":50,"timeFrame":34},"Motor","Motor index scores on Bayley Scales of Infant and Toddler Development-4th Edition at 20 months CA.",[],"ALL","3 Years",{"inclusion":55,"exclusion":58,"raw_text":63},[56,57],"Completion of the ReDiMOM RCT","survival of infant to NICU discharge",[59,60,61,62],"Mother has participated in this study with a previous pregnancy","infant is enrolled in another study that impacts neurodevelopment or adiposity","in the neonatologist's opinion the infant is unlikely to survive","the mother is unable or unwilling to provide consent","Inclusion Criteria:\n\n* Completion of the ReDiMOM RCT\n* survival of infant to NICU discharge\n\nExclusion Criteria:\n\n* Mother has participated in this study with a previous pregnancy\n* infant is enrolled in another study that impacts neurodevelopment or adiposity\n* in the neonatologist's opinion the infant is unlikely to survive\n* the mother is unable or unwilling to provide consent",[65],"CHILD",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"Rush University","Chicago","Illinois","60612","United States",{"lat":74,"lon":75},41.85003,-87.65005,[],[78,81],{"name":79,"affiliation":68,"role":80},"Aloka L Patel, MD","PRINCIPAL_INVESTIGATOR",{"name":82,"affiliation":68,"role":80},"Tricia Johnson, PhD",[84],{"pmid":85,"type":86,"citation":87},"41748748","RESULT","Kraemer MK, Johnson TJ, Bell KA, Mulcahy DC, Cerwinske LA, Patra K, Appelhans BM, David J, Belfort MB, Diep QM, Patel AL. Neonatal steroid exposure and body composition in preterm infants at discharge. Pediatr Res. 2026 Feb 27:10.1038\u002Fs41390-026-04796-w. doi: 10.1038\u002Fs41390-026-04796-w. Online ahead of print.",[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Premature infant",[],{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an observational study, meaning researchers will watch and collect information without providing new treatments. It plans to include about 275 children.","completed","Early Childhood Outcomes for Very Low Birth Weight Infants","This study is looking at the long-term health and development of children who were born very prematurely (very low birth weight) and whose mothers participated in a previous study called ReDiMOM. The ReDiMOM study offered an economic incentive to mothers to encourage them to provide their own milk. This current study will follow these children from when they leave the hospital until they are two years old. Researchers want to see how their thinking abilities (cognition) and body fat (adiposity) at age two are related to the group their mothers were in during the ReDiMOM study, and how long they received their mother's own milk during their first year of life. You may be able to join if your child completed the ReDiMOM study and survived to be discharged from the NICU (Neonatal Intensive Care Unit).","Children will be followed until they are 2 years old.",136,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]