[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"meconium-obstruction-of-prematurity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:meconium-obstruction-of-prematurity":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100519827","saline-enema-administration-in-meconium-obstruction-of-prematurity-and-impact-on-the-resolution-feeds-microbiome-and-gut-brain-axis-100519827",false,"NCT06048614","Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.","The Administration of Saline Enema Versus Glycerin Suppository as a Treatment Intervention for Meconium Obstruction of Prematurity (MOP) and to Study the Impact on the Resolution of MOP, Time to Reach Full Enteral Feeds, Gut Microbiome, and Gut-brain Axis, a Randomised Control Trial.","Inclusion Criteria:\n\n* Criteria A: For infant presenting with early onset of MOP\n\n  1. Birth weight 500 - 1250 gram\n  2. ≥ 23 weeks gestation\n  3. No BO for 48 hours\n  4. BO present but with a small amount or stain of meconium\n  5. Feeds intolerance or abdominal X-ray showing dilated loops of bowel\n* Criteria B: For infant presenting with Late onset of MOP\n\n  1. Birth weight 500 - 1250 gram\n  2. ≥ 23 weeks gestation\n  3. Infants who passed meconium initially and develop evidence of meconium obstruction at a later age (feed intolerance or vomiting and abnormal abdominal X-ray with or without abdominal distension)\n\nExclusion Criteria:\n\nInfants that:\n\n1. Neuromuscular disorder\n2. Moderate or severe asphyxia\n3. Inability to start enteral feeding, which continued for 3 consecutive days before 2 weeks of post-natal age for reasons unrelated to meconium inspissation or its complication\n4. Without parental consent\n5. Aggravated medical instability\n6. Single mothers \\\u003C 21 years",true,"ALL","1 Day","36 Weeks",{"count":21,"type":22},95,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to study the effect of twice-daily saline enema (SE) in the treatment obstruction of prematurity (MOP) in infants with the birth weight ≤1.25kg. The main questions, the trial aims to answer are\n\n1. To validate the finding of our pilot study which had shown that twice-daily SE reduces the time to reach full enteral feeds in premature infant as compared to premature infant treated with Glycerine Suppository (GS), in a larger cohort. Infant with MOP fails to pass meconium in the first 48 hours of life and develop symptoms and signs like abdominal distension and feed intolerance.\n2. The other aims of this study are to test whether the intervention is\n\n   1. Effective treatment for MOP\n   2. Reduce the duration of ICU stay\n   3. Reduce the rate of necrotizing enterocolitis, sepsis, Total Parenteral Nutrition (TPN) days and number of intravenous catheter days\n3. The study also wants to explore the impact of this intervention on the gut microbiome, gut-brain interaction and immune response of the new-born.",[28],"Meconium Obstruction of Prematurity","RECRUITING","2025-05-20",{"date":32,"type":33},"2025-05-23","ACTUAL",{"date":35,"type":33},"2024-01-02",{"date":37,"type":22},"2027-12-31",{"name":39,"class":40},"KK Women's and Children's Hospital","OTHER_GOV",2]