[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559873":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":85,"studyPopulation":78,"armGroups":86,"interventions":104,"overallOfficials":118,"centralContacts":123,"locations":133,"responsibleParty":148,"collaborators":78,"id":150,"slug":78,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":78,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":157,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":78,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":136,"whyStopped":78,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"Heilongjiang Feihe Dairy Co. Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":67},[9,13],{"measure":10,"description":11,"timeFrame":12},"Intestinal indicators","16s rRNA","day 28,180,360",{"measure":10,"description":14,"timeFrame":12},"SCFAs",[16,20,23,26,28,32,34,36,38,41,43,46,48,50,52,54,56,58,60,62,65],{"measure":17,"description":18,"timeFrame":19},"Inflammatory markers","serum hsCRP","day 180,360",{"measure":21,"description":22,"timeFrame":19},"Nutritional indicators","serum albumin",{"measure":24,"description":25,"timeFrame":12},"Immune indicators","fecal sIgA",{"measure":24,"description":27,"timeFrame":19},"blood lymphocyte subsets",{"measure":29,"description":30,"timeFrame":31},"Growth and development indicators","height","day 28,90,180,360",{"measure":29,"description":33,"timeFrame":31},"weight",{"measure":29,"description":35,"timeFrame":31},"head circumference",{"measure":29,"description":37,"timeFrame":31},"chest circumference",{"measure":39,"description":40,"timeFrame":19},"Bone development indicators","osteocalcin",{"measure":39,"description":42,"timeFrame":19},"alkaline phosphatase",{"measure":44,"description":45,"timeFrame":31},"Tolerance indicators","investigation of infant gastrointestinal comfort：In the past week, the average daily number of reflux .The minimum number is 0, and there is no limit to the maximum number.",{"measure":44,"description":47,"timeFrame":31},"investigation of infant gastrointestinal comfort：In the past week, abdominal pain VAS score of the infant.The minimum score is 0, and the maximum score is 10.",{"measure":44,"description":49,"timeFrame":31},"investigation of infant sleep crying：In the past week, the average daily crying time.The minimum time is 0 hours and the maximum time is 24 hours.",{"measure":44,"description":51,"timeFrame":31},"investigation of infant sleep crying：In the past week, the average daily crying frequency.The minimum number of times is 0, and the maximum number of times is unlimited.",{"measure":44,"description":53,"timeFrame":31},"investigation of infant sleep crying：In the past week, the average daily crying severity. The severity of crying is divided into no crying, mild crying, moderate crying, very crying, and extreme crying.",{"measure":44,"description":55,"timeFrame":31},"investigation of infant sleep crying：In the past week, the average daily crying daytime and nighttime sleep duration. The minimum time is 0 hours and the maximum time is 12 hours.",{"measure":44,"description":57,"timeFrame":31},"investigation of infant sleep crying：In the past week, sleep problems of infants.Sleep problems are divided into no problem, minor problem, moderate problem, major problem, and extreme problem.",{"measure":44,"description":59,"timeFrame":31},"investigation of infant diarrhea and upper respiratory tract infections：The severity of diarrhea and upper respiratory tract infections (colds) in infants from birth until now. The severity level is classified as no problem, minor problem, moderate problem, major problem, and maximum problem.",{"measure":44,"description":61,"timeFrame":31},"Bristol stool classification of infant feces",{"measure":63,"description":64,"timeFrame":31},"Cognitive Development","Bailey Infant Development Scale (Version IV) Score（130 or above, very excellent; 120-129, excellent; 110\\~119, upper middle; 90-109, moderate; 80-89, below average; 70-79, critical state; Below 69, developmental delay）",{"measure":63,"description":66,"timeFrame":19},"Serum Amino Acids",[68,71],{"measure":69,"description":69,"timeFrame":70},"adverse event","1 year",{"measure":72,"description":72,"timeFrame":70},"Serious adverse events",{"allocation":74,"interventionModel":75,"interventionModelDescription":76,"primaryPurpose":77,"observationalModel":78,"timePerspective":78,"maskingInfo":79},"RANDOMIZED","PARALLEL","multicenter, double-blind, randomized, controlled trial","BASIC_SCIENCE",null,{"masking":80,"maskingDescription":81,"whoMasked":82},"DOUBLE","This clinical study is a double-blind trial, and before unblinding, neither the researchers nor the subjects know whether they belong to the experimental group or the control group",[83,84],"PARTICIPANT","INVESTIGATOR","In this clinical trial, the effects of adding oligosaccharides to breast milk and optimizing multiple nutrients in infant formula, conventional infant formula, and breast milk on the growth and development of infants under 1 year old were evaluated by comparing the intestinal indicators (16s rRNA, SCFAs), inflammatory indicators, nutritional indicators, immune indicators, growth and development indicators, bone development indicators, tolerance indicators, cognitive development, adverse events, and serious adverse events of 80 experimental groups, 80 control groups, and 80 breastfeeding groups",[87,93,99],{"label":88,"type":89,"description":90,"interventionNames":91},"experimental group","EXPERIMENTAL","Feeding infant formula with added milk oligosaccharides and optimized for multiple nutrients",[92],"Dietary Supplement: oligosaccharides and multiple nutrients",{"label":94,"type":95,"description":96,"interventionNames":97},"control group","ACTIVE_COMPARATOR","Feeding with regular infant formula milk powder",[98],"Dietary Supplement: no oligosaccharides and optimizing multiple nutrients",{"label":100,"type":95,"description":101,"interventionNames":102},"Breastfeeding group","Breastfeeding with breast milk",[103],"Dietary Supplement: breastfeeding",[105,110,114],{"type":106,"name":107,"description":108,"armGroupLabels":109,"otherNames":78},"DIETARY_SUPPLEMENT","oligosaccharides and multiple nutrients","The effect of adding milk oligosaccharides and optimizing multiple nutrients to infant formula on the growth and development of infants aged 0-1 years",[88],{"type":106,"name":111,"description":112,"armGroupLabels":113,"otherNames":78},"no oligosaccharides and optimizing multiple nutrients","The effect of traditional infant formula milk powder optimized without adding milk oligosaccharides and multiple nutrients on the growth and development of infants aged 0-1 years old.",[94],{"type":106,"name":115,"description":116,"armGroupLabels":117,"otherNames":78},"breastfeeding","The impact of breastfeeding on the growth and development of infants aged 0-1 years old.",[100],[119],{"name":120,"affiliation":121,"role":122},"Xu Z Wang, doctor","Nanjing Medical University","STUDY_CHAIR",[124,129],{"name":125,"role":126,"phone":127,"phoneExt":127,"email":128},"Hao W Su, Master","CONTACT","+8613413399214","suwuhao@esmile.com.cn",{"name":130,"role":126,"phone":131,"phoneExt":131,"email":132},"Wei Q Zhang, Bachelor","+8615500023637","zhangqiwei@esmile.com.cn",[134],{"facility":135,"status":136,"city":137,"state":138,"zip":139,"country":140,"countryCode":141,"cosmosGeoPoint":142,"geoPoint":147,"contacts":78},"The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army","RECRUITING","Beijing","Beijing Municipality","100000","China","CN",{"type":143,"coordinates":144},"Point",[145,146],116.39723,39.9075,{"lat":146,"lon":145},{"type":149,"investigatorFullName":78,"investigatorTitle":78,"investigatorAffiliation":78,"oldNameTitle":78,"oldOrganization":78},"SPONSOR","100559873",false,"NCT06569797","Effect of Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on Growth and Development of Infants","The Effect of Adding Milk Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on the Growth and Development of Infants Aged 0-1 Years: a Multicenter, Double-blind, Randomized, Controlled Trial","Inclusion Criteria:\n\n* 0-28 days after birth;\n* Single birth;\n* The gestational age is between 37 and 42 weeks;\n* Birth weight ranges from 2500 to 4000 grams;\n* Parents or guardians agree not to allow infants to participate in other interventional clinical studies during the study period\n\nExclusion Criteria:\n\n* Artificial assisted reproduction;\n* The mother suffers from a disease that may endanger intrauterine growth;\n* The mother suffers from pregnancy diabetes or serious metabolic disease or chronic disease during pregnancy\n* Suffering from congenital malformations and genetic diseases, chronic diseases, and congenital diseases that may interfere with the investigation;\n* Suffering from IgE mediated milk protein allergy, or having factors that increase the risk of milk protein allergy;\n* Suffering from acute infection or gastroenteritis;\n* Suffering from functional gastrointestinal diseases, such as gastroparesis;\n* Currently participating in other clinical trials;\n* Researchers cannot determine whether parents have the willingness or ability to comply with the requirements of the protocol.",true,"ALL","0 Days","28 Days",{"count":161,"type":162},240,"ESTIMATED","INTERVENTIONAL",[165],"NA","The research objective is to compare the effects of infant formula supplemented with milk oligosaccharides and optimized with multiple nutrients on the immune function of infants under 1 year old with conventional infant formula, and to compare the effects of different infant formulas on infant intestinal health, immune function, growth and development, cognitive development, and tolerance with those of breastfed infants.",[168],"Healthy",[170,171,172],"Milk oligosaccharides","multiple nutrients","infants","2024-08-21",{"date":175,"type":176},"2024-08-26","ACTUAL",{"date":178,"type":176},"2024-01-08",{"date":180,"type":162},"2025-09-30",{"name":5,"class":6},1]