[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553446":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":25,"overallStatus":89,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University Hospital Southampton NHS Foundation Trust","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Targeted breast milk fortification using preemie device","EXPERIMENTAL","Mother's breast milk (MBM) or Donor Breast Milk (DBM) for use in a day's milk feeds will be measured using the Preemie sensor every 2-3 days, results recorded, and the amounts of breast milk fortifier (BMF), protein supplement, carbohydrate supplement and fat supplements needed to be added in order for that sample of milk to meet current 2022 European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) enteral nutrient intake recommendations calculated by the Preemie Sensor NutriNTrack software. Feeds will be made up in batches of 24hrs worth of feeds each day based on these calculations and the resulting supplement amounts used for the next 2-3 days until another sample of MBM is analysed, in line with previous work by Rochow et al",[13,14],"Device: Targeted breast milk fortification using preemie device","Dietary Supplement: Standard Breast milk fortification",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Fortification","ACTIVE_COMPARATOR","Mother's breast milk (MBM) or Donor Breast Milk (DBM) for use in a day's milk feeds will be measured using the Preemie sensor every 2-3 days and results recorded. Breast milk will then be fortified in the standard way according to the manufacturer's recommendations, which assume a standard macronutrient content of the milk.",[14],[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Mother's breast milk will have additional macronutrient added to it based on analysis with the Preemie device, to ensure it meets current European recommendations for nutrient intakes for preterm infants",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DIETARY_SUPPLEMENT","Standard Breast milk fortification","Standard multicomponent breast milk fortifier will be added to mother milk as per usual practice for preterm infants",[16,9],[32],{"name":33,"affiliation":5,"role":34},"Mark J Johnson, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Andrew Guy","CONTACT","+442381205146","andrew.guy@uhs.nhs.uk",{"name":42,"role":38,"phone":39,"phoneExt":25,"email":43},"Sharon Davies-Dear","sharon.davies-dear@uhs.nhs.uk",[45],{"facility":5,"status":25,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Southampton","Hampshire","SO16 6YD","United Kingdom","UK",{"type":52,"coordinates":53},"Point",[54,55],-1.40428,50.90395,{"lat":55,"lon":54},[58,59],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":60,"role":34,"phone":25,"phoneExt":25,"email":25},"Mark Johnson, PhD",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[64],{"name":65,"class":66},"Tellspec Ltd","UNKNOWN","100553446","preemie-milk-analyser-validation-study-100553446",false,"NCT06486194","Preemie Milk Analyser Validation Study","Analytical Validation and Clinical Testing of the Preemie System for Analysis and Calculation of Targeted Fortification of Mother's Breast Milk for Preterm Infants","Inclusion criteria Phase 1A For University Hospital Southampton (UHS) milk bank donors\n\n* Approved as a donor for the UHS milk bank through the usual process\n* Be providing milk to UHS donor milk bank For mothers of infant inpatients\n* Have an infant who is currently an inpatient in the neonatal unit, paediatric wards, paediatric cardiac ward, or paediatric intensive care unit\n* Be providing breastmilk for their preterm or term born infant\n* Have sufficient breast milk available such that providing 120ml breast milk for the study does not impact on the needs of their infant.\n\nInclusion criteria Phase 1B\n\n* Approved as a donor for the UHS milk bank through the usual process\n* Be providing milk to UHS donor milk bank\n\nExclusion criteria Phase 1A and 1B For mothers of infant inpatients\n\n\\- Mothers whose infants are inpatients and where there is a concern about adequacy of maternal milk supply to feed their infant\n\nInclusion Criteria Phase 2\n\n* Birth weight ≥1kg and \\\u003C1.8 kg (so meet the ESPGHAN criteria for breast milk fortification)\n* Be taking fully fortified enteral breast milk feeds (≥150 ml\u002Fkg\u002Fday of mothers or donor breast milk containing breast milk fortifier as per the manufacturer's instructions)\n* Tolerating fully fortified breast milk feeds≥150 ml\u002Fkg\u002Fday for 48 hours\n* No longer on parenteral nutrition.\n\nExclusion Criteria Phase 2\n\n* Infants where there is a concern about mother's supply of breast milk being insufficient to meet demands (where donor milk is not being used to make up any shortfall);\n* Known congenital metabolic disorder;\n* Infant formula fed;\n* Bilateral grade III or IV intraventricular haemorrhage;\n* Any infant who has had gastrointestinal tract surgery;\n* Refusal of consent;\n* Refusal for the use of breast milk fortifier\n* Birthweight \\\u003C1 kg",true,"ALL","0 Days","50 Years",{"count":79,"type":80},180,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study aims to test and validate the Preemie Ecosystem- a new device and associated software package for measuring the nutrient (fat, protein and carbohydrate) content of the breast milk of the mothers of premature babies. This is potentially useful, as premature babies have higher nutritional requirements than babies born at term near their due date. At the moment, a nutritional supplement called breast milk fortifier is added to breast milk in standard amounts to improve its nutritional content and help premature babies grow. However, we know that each mother's breast milk is different, and varies from day to day, so each mother's milk may require more or less of such supplements in order to meet European recommendations for the nutrient intake.\n\nThe aim of this study is to first test and validate the accuracy of the Preemie device for measuring the nutritional content of mother's breast milk, using milk donated to the local donor milk bank and from mothers of babies currently on the neonatal unit. Next, once this is complete, the aim is to demonstrate it is feasible to use the Preemie device to enable fortification of mother's milk on an individualised basis for a small group of premature babies. The growth and nutrient intakes of these babies will be compared to another group who are cared for using the standard fortification approach.\n\nThe results of this study will be used to gain \"Conformité Européenne\" (CE) certification of the Preemie device and software.",[86,87,88],"Pre-Term","Breast Milk Expression","Nutrition Disorder, Infant","NOT_YET_RECRUITING","2024-06-26",{"date":92,"type":93},"2024-07-03","ACTUAL",{"date":95,"type":80},"2024-07-01",{"date":97,"type":80},"2026-07-01",{"name":5,"class":6},1]