[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645526":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":18,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":18,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":59,"enrollmentInfo":60,"targetDuration":18,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":77,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Structured Dietary Pattern Group","EXPERIMENTAL","Individualized, face-to-face guidance and tailored recipes provided by a registered dietitian, focusing on the scientific introduction of prebiotic-rich complementary foods to promote endogenous beneficial gut bacteria over a 6-month period.",[13],"Behavioral: Structured High-Prebiotic Dietary Pattern",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care Group","NO_INTERVENTION","Preterm infants in this group will receive routine neonatal follow-up and standard infant feeding practices for 6 months.",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","Structured High-Prebiotic Dietary Pattern",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"WenXian Wang, Doctor","CONTACT","+86 13816964779","24111020016@m.fudan.edu.cn",[31],{"facility":32,"status":18,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Shanghai Children's Hospital","Shanghai","Shanghai Municipality","200062","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":28,"phoneExt":18,"email":29},"Jinjin Chen, doctor",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Gengsheng He","Professor, School of Public Health, Fudan University","100645526","dietary-pattern-intervention-for-neurodevelopment-in-preterm-infants-100645526",false,"NCT07702734","Dietary Pattern Intervention for Neurodevelopment in Preterm Infants","Effect of Gut Microbiota Remodeling Via Structured Prebiotic Dietary Pattern on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Preterm infants with a gestational age between 28 and 37 weeks (inclusive of 28 weeks)\n* Documented history of neonatal intravenous antibiotic exposure for at least 5 consecutive days during the neonatal period (e.g., in the NICU).\n* Corrected age of 6 months ± 7days at the time of enrollment.\n* No systemic antibiotic usage within 14 days prior to screening.\n* Legal guardians are willing to sign the informed consent form and comply with the 6-month intervention and follow-up schedule.\n\nExclusion Criteria:\n\n* Severe congenital malformations, chromosomal abnormalities, or inherited metabolic diseases (e.g., Down syndrome).\n* Severe neurological disorders or structural brain injuries (e.g., Grade III\u002FIV intraventricular hemorrhage, cystic periventricular leukomalacia, or hydrocephalus requiring a shunt).\n* Severe chronic diseases affecting growth and development (e.g., congenital heart disease requiring surgery, short bowel syndrome, or severe sequelae of necrotizing enterocolitis).\n* Concurrent participation in other interventional clinical trials.\n* Planned long-term use of other commercial probiotic\u002Fprebiotic supplements outside the study protocol during the intervention period.\n* High risk of loss to follow-up (e.g., expected relocation).","ALL","6 Months",{"count":61,"type":62},116,"ESTIMATED","INTERVENTIONAL",[65],"NA","The purpose of this randomized controlled trial is to evaluate the effect of a structured, high-prebiotic dietary pattern on the neurodevelopmental outcomes of preterm infants. The intervention lasts for 6 months and aims to promote the growth of endogenous beneficial gut bacteria through targeted complementary feeding. The primary outcome is assessed by the Gesell Developmental Schedules or the Ages \\& Stages Questionnaires (ASQ-3). Secondary outcomes include longitudinal changes in gut microbiota composition,targeted metabolomics (such as short-chain fatty acids and tryptophan metabolites), and systemic inflammatory markers.",[68,69,70],"Preterm","Neurodevelopmental Disorders","Dysbiosis",[72,73,74,75,76],"Dietary Pattern","Prebiotics","Gut-Brain Axis","Neonatal Antibiotic Exposure","Preterm Infants","NOT_YET_RECRUITING","2026-07-09",{"date":80,"type":81},"2026-07-14","ACTUAL",{"date":83,"type":62},"2026-07-01",{"date":85,"type":62},"2027-12-31",{"name":5,"class":6},1]