[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07661992":3,"trial-entities:NCT07661992":109,"trial-summary:NCT07661992":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":52,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":83,"locations":85,"central_contacts":100,"overall_officials":103,"references":107,"see_also_links":108},"NCT07661992","IRB00150290","Breast-milk Enema Administration to Stimulate Passage of Meconium","Breast-Milk Enema Administration to Stimulate Meconium Passage in Preterm Infants","NOT_YET_RECRUITING","2027-07","2026-06","2026-07-28","2026-10","Wake Forest University Health Sciences","OTHER",false,"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","Breast milk is a natural oil-in-water emulsion that can soften meconium, lubricate, and stimulate the intestinal wall, making it easier to excrete meconium. The osmotic pressure of breast milk is a benign stimulus to the digestive tract of premature infants. In addition, breast milk contains bioactive compounds that may positively influence gut motility and the microbiome and has been shown to decrease the incidence of NEC. A small-volume rectal enemas using mother's own breast milk in preterm infants born at \\\u003C28 weeks' gestation with delayed passage of meconium (\\>48 hours of life) are feasible and safe, and may be associated with earlier meconium passage and improved early feeding outcomes without increasing the risk of necrotizing enterocolitis (NEC) or other gastrointestinal complications.",[19],"Breast-milk",[21,22,23],"Meconium","rectal enemas","low birth weight infants","INTERVENTIONAL","PREVENTION",[27],"PHASE1",{"count":29,"type":30},20,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","breast milk","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.",[34],[38,41,43,46,49],{"measure":39,"description":39,"timeFrame":40},"Recruitment rate","Day 1",{"measure":42,"description":42,"timeFrame":40},"Protocol adherence rate",{"measure":44,"description":44,"timeFrame":45},"Incidence of necrotizing enterocolitis (NEC)","Day 14",{"measure":47,"description":47,"timeFrame":48},"Incidence of culture proven sepsis","Day 7",{"measure":50,"description":51,"timeFrame":48},"Incidence of rectal or gastrointestinal injury","Incidence of rectal or gastrointestinal injury - Rectal trauma will be assessed clinically by the presence of bleeding, fissure, or other visible anorectal injury on physical examination.",[53,56,59,61,64],{"measure":54,"description":55,"timeFrame":45},"Time to achieve full enteral feeds","Enteral feeds (enteral nutrition or tube feeding) times",{"measure":57,"description":58,"timeFrame":45},"Duration of parenteral nutrition","Parenteral nutrition (PN) is a method of delivering essential nutrients directly into the bloodstream through an intravenous (IV) catheter.",{"measure":60,"description":60,"timeFrame":48},"Time to first stool following intervention",{"measure":62,"description":62,"timeFrame":63},"Total length of hospital stay","Day 120",{"measure":65,"description":65,"timeFrame":63},"Number of central line days","ALL","23 Weeks","28 Weeks",{"inclusion":70,"exclusion":75,"raw_text":82},[71,72,73,74],"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.","postnatal age \\>48 hours, absence of spontaneous passage of meconium by \\>48 hours of life","availability of mother's own milk","written informed consent obtained from a parent or legal guardian.",[76,77,78,79,80,81],"Infants with Necrotizing Enterocolitis (NEC) ≥ stage II","spontaneous intestinal perforation (SIP)","gastrointestinal or anorectal malformations","infants that have developed severe hemodynamic instability or sepsis with need for vasoactive drugs","significant hematologic abnormalities such as neutropenia or thrombocytopenia.","Infants will also be excluded in the absence of written informed consent from a parent or legal guardian.","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.",[84],"CHILD",[86],{"facility":13,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":97},"Winston-Salem","North Carolina","27157","United States",[92],{"name":93,"role":94,"phone":95,"email":96},"Monica C Gierbolini Collazo, MD","CONTACT","787-239-6289","monica.gierbolinicollazo@advocatehelth.org,",{"lat":98,"lon":99},36.09986,-80.24422,[101],{"name":93,"role":94,"phone":95,"email":102},"monica.gierbolinicollazo@advocatehelth.org",[104],{"name":105,"affiliation":13,"role":106},"Ricardo J Rodriquez, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":110,"biomarkers":113},[111,112],"Meconium Impaction","Premature infant",[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study with an unspecified phase, planning to enroll 20 participants. It involves giving breast milk as an enema.","completed","Breast-milk Enema for Preterm Infants with Delayed Meconium Passage","This study is looking at whether giving a small enema of a mother's own breast milk can help very premature babies (born between 23 and 28 weeks of pregnancy) pass their first stool (meconium) if they haven't done so within 48 hours of birth. Delayed meconium passage can cause problems like necrotizing enterocolitis (NEC), a serious gut condition. Researchers believe breast milk might soften the meconium and help the baby's intestines move it along. The study will measure how many babies are recruited, how well the study plan is followed, and if there's any change in the rate of NEC. This study plans to enroll 20 babies and its current status is unclear.","The study will track the incidence of necrotizing enterocolitis (NEC) for 14 days after the intervention.",113,"You would need to provide consent for your baby to receive a small breast milk enema, possibly with one repeat dose after 24 hours if needed. Your baby must be born at Atrium Health Wake Forest Baptist Hospital or transferred there within 24 hours of birth, and your own breast milk must be available.","Not stated in the trial record.",[34],"v2"]