[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06072976":3,"trial-entities:NCT06072976":145,"trial-summary:NCT06072976":150},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":14,"eligibility_criteria":71,"std_ages":76,"locations":79,"central_contacts":103,"overall_officials":105,"references":107,"see_also_links":144},"NCT06072976","STUDY00004330: CGP Milk","The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies","RECRUITING","2027-06-09","2026-04","2026-04-30","2023-06-09","Seattle Children's Hospital","OTHER",false,"This study explores the use of an exclusive human milk diet versus standard feeding practices to compare the influence on feeding outcomes and the gut bacteria in infants with intestinal differences.",null,[18,19,20,21,22,23],"Gastrointestinal Complication","Intestinal Obstruction","Gastroschisis","Hirschsprung Disease","Omphalocele","Midgut Volvulus",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},116,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DIETARY_SUPPLEMENT","Standard of Care","Standard of care arm: Mothers will consent to providing DHM (if qualifies per hospital policy) or formula if MOM is not available. Infants are only eligible to receive donor milk only if 1) MOM is not available 2) if infant initiates feeds before day 3 of age. The donor milk feed would be stopped on day 5 of age.",[38],"Standard of care",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Exclusive Human Milk","Mothers will consent to providing DHM if MOM is not available. If the infant reaches 100 ml\u002Fkg\u002Fday of feeds (one feed advancement prior to full feeds) and MOM remains unavailable, they will transition to formula in preparation for discharge. Infants cannot be discharged on donor milk.",[43],"Exclusive human milk",[45],{"measure":46,"description":47,"timeFrame":48},"Time to full feed",": In infants with congenital gastrointestinal pathologies (gastroschisis, giant omphalocele, atresia, midgut volvulus, Hirschsprung disease, CGP), to determine if use of an exclusive human milk diet will decrease the number of days to full feeding volume (120 ml\u002Fkg\u002Fday) (29 subjects per power calculation) compared to human milk\u002Fformula","From birth to 120 days or until discharge",[50,54,58,61,64],{"measure":51,"description":52,"timeFrame":53},"Central line infection rate","To compare rate of central line infections in infants given exclusive human milk versus infants given standard care.","up to 120 days or discharge",{"measure":55,"description":56,"timeFrame":57},"Portion of parents own milk at time of discharge",": To compare proportion of parents providing any\u002Fexclusive mother's own milk (MOM) at discharge in infants given exclusive human milk arm versus standard care arm","Up to 120 days or discharge",{"measure":59,"description":60,"timeFrame":57},"Gut Microbiome Relative Abundance and Diversity","To examine if utilization of donor milk when mother's own milk is insufficient alters the infant's gut microbiome alpha diversity and beta diversity and bacterial relative abundances",{"measure":62,"description":63,"timeFrame":57},"Mother's milk microbiome relative abundance and diversity","To discern how mother's own milk microbiome differs from donor milk microbiome relative abundances and diversity. We will examine how the milk microbiomes influences the infant's gut microbiome and time to full feeds.",{"measure":65,"description":66,"timeFrame":67},"Concentrations of Antigen-specific immunoglobulins","To compare total and antigen-specific immunoglobulins in donor milk versus MOM","From birth to 120 days or discharge","ALL","0 Days","55 Years",{"inclusion":72,"exclusion":74,"raw_text":75},[73],"Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.",[],"Inclusion Criteria:\n\n* Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.\n\nExclusion Criteria:\n\n1. Infant has already been on feeds\n2. Infants \\\u003C34 weeks gestation\n3. Parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth BUT oxy\u002Fsuboxone\u002Fmarijuana OK)\n4. Complicated gastroschisis\n5. Short gut syndrome\n6. Additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease BUT kidney disease ok)",[77,78],"CHILD","ADULT",[80],{"facility":12,"status":7,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":100},"Seattle","Washington","98105","United States",[86,91,95,98],{"name":87,"role":88,"phone":89,"email":90},"Katie Strobel, MD","CONTACT","262-623-1987","katie.strobel@seattlechildrens.org",{"name":92,"role":88,"phone":93,"email":94},"Leonel Arellano","915-443-4390","leonel.arellano@seattlechildrens.org",{"name":96,"role":97},"Patrick Javid, MD","SUB_INVESTIGATOR",{"name":87,"role":99},"PRINCIPAL_INVESTIGATOR",{"lat":101,"lon":102},47.60621,-122.33207,[104],{"name":92,"role":88,"phone":93,"email":94},[106],{"name":87,"affiliation":12,"role":99},[108,112,115,118,121,124,127,130,132,135,138,141],{"pmid":109,"type":110,"citation":111},"30119100","BACKGROUND","Varma S, Bartlett EL, Nam L, Shores DR. Use of Breast Milk and Other Feeding Practices Following Gastrointestinal Surgery in Infants. J Pediatr Gastroenterol Nutr. 2019 Feb;68(2):264-271. doi: 10.1097\u002FMPG.0000000000002128.",{"pmid":113,"type":110,"citation":114},"32102333","Hoban R, Khatri S, Patel A, Unger SL. Supplementation of Mother's Own Milk with Donor Milk in Infants with Gastroschisis or Intestinal Atresia: A Retrospective Study. Nutrients. 2020 Feb 24;12(2):589. doi: 10.3390\u002Fnu12020589.",{"pmid":116,"type":110,"citation":117},"32298596","Bergner EM, Shypailo R, Visuthranukul C, Hagan J, O'Donnell AR, Hawthorne KM, Abrams SA, Hair AB. Growth, Body Composition, and Neurodevelopmental Outcomes at 2 Years Among Preterm Infants Fed an Exclusive Human Milk Diet in the Neonatal Intensive Care Unit: A Pilot Study. Breastfeed Med. 2020 May;15(5):304-311. doi: 10.1089\u002Fbfm.2019.0210. Epub 2020 Apr 16.",{"pmid":119,"type":110,"citation":120},"29877722","Hair AB, Rechtman DJ, Lee ML, Niklas V. Beyond Necrotizing Enterocolitis: Other Clinical Advantages of an Exclusive Human Milk Diet. Breastfeed Med. 2018 Jul\u002FAug;13(6):408-411. doi: 10.1089\u002Fbfm.2017.0192. Epub 2018 Jun 7.",{"pmid":122,"type":110,"citation":123},"30291318","Murthy S, Parker PR, Gross SJ. Low rate of necrotizing enterocolitis in extremely low birth weight infants using a hospital-based preterm milk bank. J Perinatol. 2019 Jan;39(1):108-114. doi: 10.1038\u002Fs41372-018-0235-3. Epub 2018 Oct 5.",{"pmid":125,"type":110,"citation":126},"34012050","Fleig L, Hagan J, Lee ML, Abrams SA, Hawthorne KM, Hair AB. Growth outcomes of small for gestational age preterm infants before and after implementation of an exclusive human milk-based diet. J Perinatol. 2021 Aug;41(8):1859-1864. doi: 10.1038\u002Fs41372-021-01082-x. Epub 2021 May 19.",{"pmid":128,"type":110,"citation":129},"36127395","Hair AB, Good M. Dilemmas in feeding infants with intestinal failure: a neonatologist's perspective. J Perinatol. 2023 Jan;43(1):114-119. doi: 10.1038\u002Fs41372-022-01504-4. Epub 2022 Sep 20.",{"type":110,"citation":131},"Strobel KM, Kramer K, Rottkamp CA, Uy C, Moyer L, Fernandez E, Elashoff D, Sabnis A, and Calkins KL. Implementation of a Nutritional Pathway Across California Hospitals Improves Linear Growth in Neonates with Gastroschisis: A University of California Fetal Consortium Study. Pediatric Academic Societies, 4\u002F22\u002F2022, Denver, CO.",{"pmid":133,"type":110,"citation":134},"35058060","Hodgson EC, Livingston MH, Robinson T, Farrokhyar F, Walton JM. Use of breast milk in infants with uncomplicated gastroschisis: A retrospective cohort study. J Pediatr Surg. 2022 May;57(5):840-845. doi: 10.1016\u002Fj.jpedsurg.2021.12.045. Epub 2022 Jan 13.",{"pmid":136,"type":110,"citation":137},"29221672","Spatz DL, Robinson AC, Froh EB. Cost and Use of Pasteurized Donor Human Milk at a Children's Hospital. J Obstet Gynecol Neonatal Nurs. 2018 Jul;47(4):583-588. doi: 10.1016\u002Fj.jogn.2017.11.004. Epub 2017 Dec 6.",{"pmid":139,"type":110,"citation":140},"36029771","Kumbhare SV, Jones WD, Fast S, Bonner C, Jong G', Van Domselaar G, Graham M, Narvey M, Azad MB. Source of human milk (mother or donor) is more important than fortifier type (human or bovine) in shaping the preterm infant microbiome. Cell Rep Med. 2022 Sep 20;3(9):100712. doi: 10.1016\u002Fj.xcrm.2022.100712. Epub 2022 Aug 26.",{"pmid":142,"type":110,"citation":143},"31022910","Demers-Mathieu V, Huston RK, Markell AM, McCulley EA, Martin RL, Spooner M, Dallas DC. Differences in Maternal Immunoglobulins within Mother's Own Breast Milk and Donor Breast Milk and across Digestion in Preterm Infants. Nutrients. 2019 Apr 24;11(4):920. doi: 10.3390\u002Fnu11040920.",[],{"nct_id":4,"conditions":146,"biomarkers":149},[20,21,147,148,22],"Intestinal Atresia","Midgut volvulus",[],{"nct_id":4,"found":151,"summary":152,"prompt_version":162},true,{"design":153,"status":154,"heading":155,"summary":156,"follow_up":157,"word_count":158,"commitments":159,"compensation":160,"drugs_mentioned":161},"This is an interventional study comparing two feeding approaches in 116 planned participants. It is not specified if it is randomized or blinded.","completed","Feeding Source and Gut Health in Infants with Intestinal Conditions","This study is looking at how different feeding methods affect the gut (digestive system) and how quickly infants with certain intestinal problems can start eating normally. It compares two approaches: an \"Exclusive Human Milk\" diet, where infants receive human milk (from their mother or a donor), versus \"Standard of Care,\" which might include formula if mother's milk isn't available. The study is for infants from birth up to 55 years old who have conditions like gastroschisis (intestines outside the body), omphalocele (intestines covered by a sac outside the body), or Hirschsprung disease (a nerve problem in the large intestine). The main goal is to see which feeding method helps infants reach full feeds faster. The study plans to enroll 116 participants, but its current recruitment status is unclear.","Participants will be followed from birth to 120 days or until discharge to measure the time to full feed.",128,"Not specified in the trial record.","Not stated in the trial record.",[35,40],"v2"]