[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635885":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":24,"locations":24,"responsibleParty":29,"collaborators":33,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":24,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":65,"whyStopped":24,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":24},{"fullName":5,"class":6},"Zekai Tahir Burak Women's Health Research and Education Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rectal irrigation with maternal breast milk","EXPERIMENTAL","Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL\u002Fkg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed. Maternal breast milk will be used for rectal irrigation.",[13],"Other: Rectal irrigation with maternal breast milk",{"label":15,"type":16,"description":17,"interventionNames":18},"Rectal irrigation with normal saline","ACTIVE_COMPARATOR","Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL\u002Fkg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed.Normal saline will be used for rectal irrigation as an active comparator.",[19],"Other: Rectal irrigation with salin",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Maternal breast milk will be used for rectal irrigation . Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL\u002Fkg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Rectal irrigation with salin","Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL\u002Fkg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed. Normal saline will be used for rectal irrigation as an active comparator.",[15],{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Funda Yavanoglu Atay","Assoc. Prof.",[34,37],{"name":35,"class":36},"Umraniye Education and Research Hospital","OTHER_GOV",{"name":38,"class":6},"Kocaeli University","100635885","effect-of-rectal-administration-of-breast-milk-on-gut-microbiota-in-preterm-infants-100635885",false,"NCT07558499","Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants","Effect of Rectal Administration of Human Milk on Gut Microbiota and Clinical Outcomes in Preterm Infants: A Randomized Controlled Study","premic","Inclusion Criteria:\n\nPreterm infants with a gestational age ≤32 weeks and birth weight ≤1500 g\n\nInfants without meconium passage within the first 48 hours of life\n\nInfants whose parents have provided written informed consent\n\nExclusion Criteria:\n\nnfants with major congenital anomalies\n\nInfants with gastrointestinal system anomalies\n\nInfants in whom administration of maternal breast milk is contraindicated\n\nInfants whose parents do not provide consent for participation\n\nInfants who die within the first 72 hours of life","ALL","22 Weeks","32 Weeks",{"count":51,"type":52},60,"ESTIMATED","INTERVENTIONAL",[55],"NA","This study aims to evaluate the effect of rectal administration of maternal breast milk on gut microbiota development in preterm infants. Preterm infants are at increased risk of dysbiosis due to immaturity and limited enteral feeding in the early postnatal period. In this randomized controlled study, preterm infants will receive either rectal administration of maternal breast milk or normal saline. The primary objective is to compare gut microbiota composition between the two groups. The findings may provide insight into a novel and non-invasive strategy to support microbiota development in preterm infants.",[58,59,60],"Premature","Gut Microbiota Diversity and Composition","NEC - Necrotizing Enterocolitis",[62,63,64],"premature","gut microbiota","preterm morbidities","NOT_YET_RECRUITING","2026-04-22",{"date":68,"type":69},"2026-04-30","ACTUAL",{"date":71,"type":52},"2026-06-15",{"date":73,"type":52},"2027-08-15",{"name":5,"class":6}]