[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655167":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":23,"overallOfficials":35,"centralContacts":40,"locations":23,"responsibleParty":46,"collaborators":23,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":23,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":23,"maxAge":58,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":23,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":76,"whyStopped":23,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":23},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Fecal calprotectin level in relation to necrotizing enterocolitis","Comparison of fecal calprotectin concentrations (µg\u002Fg) between preterm infants who develop necrotizing enterocolitis and those who do not.","Within the first 30 days of life",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Comparison of fecal calprotectin between feeding groups","Difference in fecal calprotectin levels (µg\u002Fg) between exclusively breastfed and exclusively formula-fed preterm infants.",{"measure":18,"description":19,"timeFrame":12},"Diagnostic performance of fecal calprotectin for NEC","Sensitivity, specificity, and optimal cutoff value of fecal calprotectin for predicting necrotizing enterocolitis using ROC curve analysis.",{"measure":21,"description":22,"timeFrame":12},"Correlation of feeding type with necrotizing enterocolitis","Odds ratio for the occurrence of necrotizing enterocolitis according to type of feeding (exclusively breastfed versus exclusively formula-fed), using logistic regression analysis.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","PROSPECTIVE","Necrotizing enterocolitis (NEC) is a serious gastrointestinal disease in preterm neonates associated with high morbidity and mortality. Early diagnosis remains challenging. Fecal calprotectin is a non-invasive marker of intestinal inflammation that has shown potential as an early indicator of NEC.\n\nThis prospective study will include preterm neonates less than 36 weeks gestational age or with birth weight less than 1500 grams. Fecal calprotectin levels will be measured and compared between exclusively breastfed and formula-fed infants. The association of fecal calprotectin levels with the development of necrotizing enterocolitis will be assessed.","Preterm neonates less than 36 weeks gestational age or with birth weight less than 1500 grams admitted to Assiut University Children Hospital.",[30,33],{"label":31,"type":23,"description":32,"interventionNames":23},"Exclusively breastfed preterm infants","Preterm infants will be categorized according to feeding type and followed for fecal calprotectin levels and development of necrotizing enterocolitis.",{"label":34,"type":23,"description":32,"interventionNames":23},"Exclusively formula-fed preterm infants",[36],{"name":37,"affiliation":38,"role":39},"Nafisa H Refat, prof","Pediatrics Department, Assiut University Hospitals","STUDY_CHAIR",[41],{"name":42,"role":43,"phone":44,"phoneExt":23,"email":45},"Amany M Hussien, Resident","CONTACT","+20 10 01286248","Amani.18313375@med.aun.edu.eg",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Amany Mohamed Esmat Ahmed Hussien","Resident Physician","100655167","fecal-calprotectin-in-breastfed-vs-formula-fed-preterm-infants-and-nec-100655167",false,"NCT07810543","Fecal Calprotectin in Breastfed vs Formula-Fed Preterm Infants and NEC","Fecal Calprotectin Level in Breastfed Versus Formula-Fed Preterm Infants as an Early Indicator of Developing Necrotizing Enterocolitis: A One-Year Study","Inclusion Criteria:\n\n* \\- Preterm neonates less than 36 weeks gestational age\n* Or low birth weight less than 1500 grams\n* Or both\n* Written informed consent from parents or legal guardians\n\nExclusion Criteria:\n\n* \\- Full-term neonates\n* Neonates with average birth weight\n* Preterm neonates with major congenital gastrointestinal anomalies or chromosomal abnormalities","ALL","36 Weeks",{"count":60,"type":61},112,"ESTIMATED","30 Days","OBSERVATIONAL","This prospective observational study aims to evaluate fecal calprotectin levels as an early indicator of necrotizing enterocolitis in preterm infants and to compare levels between breastfed and formula-fed preterm infants at Assiut University Children Hospital.",[66,67,68],"Necrotizing Enterocolitis","Premature","Breast Feeding",[70,71,72,73,74,75],"Fecal calprotectin","Necrotizing enterocolitis","Preterm infants","Breastfeeding","Formula feeding","Assiut","NOT_YET_RECRUITING","2026-09-08",{"date":79,"type":80},"2026-09-10","ACTUAL",{"date":82,"type":61},"2026-09-03",{"date":84,"type":61},"2028-05-10",{"name":5,"class":6}]