[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644410":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":72,"whyStopped":19,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"breast milk","EXPERIMENTAL","A small-volume rectal enema consisting of 5 mL\u002Fkg of fresh mother's own breast milk will be administered as a single dose, with the option for one repeat dose at 24 hours if clinically indicated. The prescribed enema volume (5 mL\u002Fkg) will be calculated based on current weight and warmed to 37 °C using an approved breast milk warmer.",[13],"Drug: breast milk",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","A small-volume rectal enema consisting of 5 mL\u002Fkg of fresh mother's own breast milk will be administered as a single dose, with the option for one repeat dose at 24 hours if clinically indicated.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Ricardo J Rodriquez, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Monica C Gierbolini Collazo, MD","CONTACT","787-239-6289","monica.gierbolinicollazo@advocatehelth.org",[31],{"facility":5,"status":19,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Winston-Salem","North Carolina","27157","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-80.24422,36.09986,{"lat":41,"lon":40},[44],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":45},"monica.gierbolinicollazo@advocatehelth.org,",{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100644410","phase-1-breast-milk-enema-administration-to-stimulate-passage-of-meconium-100644410",false,"NCT07661992","Breast-milk Enema Administration to Stimulate Passage of Meconium","Breast-Milk Enema Administration to Stimulate Meconium Passage in Preterm Infants","BEAM","Inclusion Criteria:\n\n* Preterm infants born at \\>23 and \\\u003C28 weeks' gestational age born at Atrium Health Wake Forest Baptist Hospital or transferred in the first 24 hours of life.\n* postnatal age \\>48 hours, absence of spontaneous passage of meconium by \\>48 hours of life\n* availability of mother's own milk\n* written informed consent obtained from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Infants with Necrotizing Enterocolitis (NEC) ≥ stage II\n* spontaneous intestinal perforation (SIP)\n* gastrointestinal or anorectal malformations\n* infants that have developed severe hemodynamic instability or sepsis with need for vasoactive drugs\n* significant hematologic abnormalities such as neutropenia or thrombocytopenia.\n* Infants will also be excluded in the absence of written informed consent from a parent or legal guardian.","ALL","23 Weeks","28 Weeks",{"count":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP). Usual management of meconium impaction has included glycerin suppositories and normal saline enemas. Various methods are used in routine neonatal care to promote meconium evacuation; however, there is no consensus on the agents used and the frequency of applications",[67],"Breast-milk",[69,70,71],"Meconium","rectal enemas","low birth weight infants","NOT_YET_RECRUITING","2026-06-25",{"date":75,"type":76},"2026-06-30","ACTUAL",{"date":78,"type":61},"2026-07",{"date":80,"type":61},"2027-01",{"name":5,"class":6},1]