[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566247":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":43,"centralContacts":52,"locations":58,"responsibleParty":73,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":11,"maxAge":89,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":11,"overallStatus":100,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"CMF","EXPERIMENTAL",null,[13],"Other: Cow's milk formula [CMF]",{"label":15,"type":10,"description":11,"interventionNames":16},"AAF",[17],"Other: Amino-acid formula [AAF]",{"label":19,"type":10,"description":11,"interventionNames":20},"DHM",[21],"Other: Donor human milk [DHM]",{"label":23,"type":10,"description":11,"interventionNames":24},"DHM-P",[25],"Other: High-pressure processed \"pascalized\" donor human milk [DHM-P]",[27,31,35,39],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Cow's milk formula [CMF]","At least 10 ml daily of cow's milk formula (Bebiko 1 NUTRIFlor Expert®, Nutricia; formula with galactooligosaccharides and without probiotics); and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.",[9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"Amino-acid formula [AAF]","At least 10 ml daily of amino-acid formula (Nutramigen Pureamino®, Reckitt Benckiser Group PLC); and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.",[15],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Donor human milk [DHM]","At least 10 ml daily of donor human milk; and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.",[19],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"High-pressure processed \"pascalized\" donor human milk [DHM-P]","At least 10 ml daily of high-pressure processed \"pascalized\" donor human milk; and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.",[23],[44,47,50],{"name":45,"affiliation":5,"role":46},"Andrea Horvath, Assoc Prof, MD","STUDY_CHAIR",{"name":48,"affiliation":5,"role":49},"Aleksandra Wesołowska, Assoc Prof","PRINCIPAL_INVESTIGATOR",{"name":51,"affiliation":5,"role":49},"Hanna Szajewska, Prof, MD",[53],{"name":54,"role":55,"phone":56,"phoneExt":11,"email":57},"Andrea Horvath, Assoc Prof","CONTACT","22 317 9444","andrea.horvath@wum.edu.pl",[59],{"facility":5,"status":11,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Warsaw","Masovian Voivodeship","02-091","Poland","PL",{"type":66,"coordinates":67},"Point",[68,69],21.01178,52.22977,{"lat":69,"lon":68},[72],{"name":54,"role":55,"phone":56,"phoneExt":11,"email":57},{"type":74,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[76],{"name":77,"class":78},"Medical Research Agency, Poland","OTHER_GOV","100566247","early-supplementation-for-cows-milk-allergy-prevention-100566247",false,"NCT06652698","Early Supplementation for Cow's Milk Allergy Prevention","Early Supplementation for Cow's Milk Allergy Prevention in Breastfed Infants in Poland (ESCAPE-PL): a Protocol for Randomised Controlled Trial","ESCAPE-PL","Inclusion criteria:\n\n1. Healthy newborns of mothers who express the intention to exclusively breastfeed for first 6 months of infant's life\n2. Full-term infants (defined as gestational age of at least 37 weeks)\n3. Infant birth weight at least 2500 g and ≤ 4500 g\n4. Age at enrolment \\\u003C24 h of life\n5. Regardless of any atopic condition in parents\n6. Written informed consent of the caregiver\n\nExclusion criteria:\n\n1. Infants of parents who intend to partially or fully formula feed\n2. Serious congenital anomalies or any other medical condition that would preclude the consumption of any of the study formulas, or interfere with nutrition or growth\n3. Contradictions to exclusive breastfeeding\n4. Multiple pregnancy",true,"ALL","24 Hours",{"count":91,"type":92},1000,"ESTIMATED","INTERVENTIONAL",[95],"NA","Cow's milk allergy (CMA) is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions, risk of nutritional deficiencies, social limitations, and decreased quality of life. It also represents a financial burden for families and healthcare resources.\n\nThere is an ongoing debate about the significance of early exposure to cow's milk proteins within hours or days after birth and its relationship to the risk of developing CMA later in life. Current recommendations for early introduction of cow's milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence. This knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cow's milk proteins and the development of CMA, which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families.\n\nThis trial aims to investigate whether early supplementation with various nutritional interventions (cow's milk formula \\[CMF\\], amino acids formula \\[AAF\\], donor human milk \\[DHM\\], or high-pressure processed \"pascalized\" donor human milk \\[DHM-P\\]) could serve as an effective strategy for the primary prevention of CMA in breastfed neonates.\n\nThis study is an open-label randomized, controlled, head-to-head trial with four parallel arms and allocation 1:1:1:1.",[98,99],"Food Allergy","Cow's Milk Allergy","NOT_YET_RECRUITING","2025-07-14",{"date":103,"type":104},"2025-07-17","ACTUAL",{"date":106,"type":92},"2025-07",{"date":108,"type":92},"2031-03",{"name":5,"class":6},1]