[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642077":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":40,"responsibleParty":114,"collaborators":25,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":25,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":25,"enrollmentInfo":126,"targetDuration":25,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":141,"whyStopped":25,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Routine Breast Milk Feeding","ACTIVE_COMPARATOR","Preterm infants in this group will receive routine breast milk feeding according to standard NICU practice. Expressed breast milk will be prepared and administered without matching the time of milk expression to the time of feeding.",[13],"Behavioral: Routine Breast Milk Feeding",{"label":15,"type":16,"description":17,"interventionNames":18},"Circadian-Synchronized Breast Milk Feeding","EXPERIMENTAL","Preterm infants in this group will receive circadian-synchronized breast milk feeding in the NICU. Expressed breast milk will be classified and labeled according to the time of milk expression into 4 time periods: morning (06:00-12:00), afternoon (12:00-18:00), evening (18:00-24:00), and late night\u002Fearly morning (00:00-06:00). During the study, breast milk collected within each predefined time period will be used preferentially for feedings scheduled within the corresponding time period. This feeding approach is intended to keep the timing information in breast milk as consistent as possible with the infant's feeding time and will continue for at least 2 weeks during the study.",[19],"Behavioral: Circadian-Synchronized Breast Milk Feeding",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","In this intervention, expressed breast milk will be classified and labeled according to the time of milk expression into 4 predefined periods: morning (06:00-12:00), afternoon (12:00-18:00), evening (18:00-24:00), and late night\u002Fearly morning (00:00-06:00). During the study, breast milk collected within each predefined time period will be used preferentially for feedings scheduled within the corresponding time period. This intervention is designed to keep the timing information in breast milk as consistent as possible with the infant's feeding time and will be implemented for at least 2 weeks.",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"In this intervention, preterm infants will receive routine breast milk feeding according to standard NICU practice. Expressed breast milk will be prepared and administered without matching the time of milk expression to the time of feeding.",[9],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Biyu Shen, PhD","CONTACT","+86 13862937317","shenbiyu@126.com",{"name":36,"role":32,"phone":37,"phoneExt":38,"email":39},"Qiuyue Zhai, MS","+86 13681734307","+86 1832140548","2319957509@qq.com",[41,57,70,79,85,97],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Fujian Children's Hospital","Fuzhou","Fujian","350014","China","CN",{"type":49,"coordinates":50},"Point",[51,52],119.30611,26.06139,{"lat":52,"lon":51},[55],{"name":56,"role":32,"phone":33,"phoneExt":25,"email":34},"Qiongxia Ou, PhD",{"facility":58,"status":25,"city":59,"state":60,"zip":61,"country":46,"countryCode":47,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Nantong First People's Hospital","Nantong","Jiangsu","226001",{"type":49,"coordinates":63},[64,65],120.87472,32.03028,{"lat":65,"lon":64},[68],{"name":69,"role":32,"phone":33,"phoneExt":25,"email":34},"Yuanyuan Zhu",{"facility":71,"status":25,"city":59,"state":60,"zip":72,"country":46,"countryCode":47,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Nantong Maternal and Child Health Hospital","226018",{"type":49,"coordinates":74},[64,65],{"lat":65,"lon":64},[77],{"name":78,"role":32,"phone":33,"phoneExt":25,"email":34},"Jinfang Yan",{"facility":80,"status":25,"city":81,"state":60,"zip":82,"country":46,"countryCode":47,"cosmosGeoPoint":25,"geoPoint":25,"contacts":83},"Children's Hospital of Soochow University","Shanghai","215025",[84],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"facility":86,"status":25,"city":87,"state":60,"zip":88,"country":46,"countryCode":47,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Zhangjiagang First People's Hospital","Zhangjiagang","215600",{"type":49,"coordinates":90},[91,92],120.53889,31.865,{"lat":92,"lon":91},[95],{"name":96,"role":32,"phone":33,"phoneExt":25,"email":34},"Minmin Sun",{"facility":98,"status":25,"city":81,"state":99,"zip":100,"country":46,"countryCode":47,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine","Shanghai Municipality","200127",{"type":49,"coordinates":102},[103,104],121.45806,31.22222,{"lat":104,"lon":103},[107,108,110,112],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"name":31,"role":109,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":36,"role":111,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":113,"role":111,"phone":25,"phoneExt":25,"email":25},"Fan fan, MS",{"type":109,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Biyu Shen","Principal Investigator","100642077","circadian-synchronized-breast-milk-feeding-and-sleep-in-preterm-infants-a-multicenter-randomized-controlled-trial-100642077",false,"NCT07645677","Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial","Effect of Circadian-Synchronized Breast Milk Feeding on Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\nPreterm infants born between 28 and 36 weeks of gestation Have reached full enteral feeding Written informed consent signed by a legal guardian\n\nExclusion Criteria:\n\nNeed invasive respiratory support, such as endotracheal intubation Use of sedatives or other medications that may affect the central nervous system or sleep rhythm\n\nPresence of diseases or abnormalities that may affect normal feeding or sleep behavior, including:\n\nCongenital anomalies, such as neurologic or chromosomal abnormalities Congenital gastrointestinal malformations or anorectal malformations Conditions affecting digestion or absorption, such as diarrhea, intestinal obstruction, or necrotizing enterocolitis (NEC) Critical illnesses such as patent ductus arteriosus (PDA), neonatal sepsis, neutropenia, or coagulation disorders","ALL","0 Days",{"count":127,"type":128},120,"ESTIMATED","INTERVENTIONAL",[131],"NA","This clinical trial aims to find out whether a circadian-synchronized breast milk feeding approach can help improve sleep in preterm infants in the neonatal intensive care unit (NICU).\n\nThe study mainly aims to answer the following questions:\n\nCan this feeding approach improve sleep in preterm infants? Can this feeding approach help preterm infants develop more regular sleep patterns compared with routine breast milk feeding?\n\nResearchers will compare a feeding approach that tries to match the time when breast milk was expressed with the time when the baby is fed, with routine breast milk feeding, to see whether this method can improve sleep in preterm infants.\n\nParticipants will:\n\nBe randomly assigned to 1 of 2 groups: circadian-synchronized breast milk feeding or routine breast milk feeding.\n\nReceive the assigned feeding approach for at least 2 weeks during the study. Have one 12-hour continuous sleep monitoring session at 37 weeks of corrected age.\n\nHave changes in different sleep states recorded and analyzed during the study, so that sleep patterns can be compared between the 2 groups.",[134,135],"Preterm Infant","Sleep",[137,138,139,140,134,135],"Breast Milk Feeding","Circadian Rhythm","Chrononutrition","NICU","NOT_YET_RECRUITING","2026-06-09",{"date":144,"type":145},"2026-06-12","ACTUAL",{"date":147,"type":128},"2026-06-01",{"date":149,"type":128},"2027-08-01",{"name":5,"class":6},6]