[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592413":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":85,"collaborators":87,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":43,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":133,"overallStatus":81,"whyStopped":43,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"The University of Queensland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PDHM - Pasteurised donor human milk","EXPERIMENTAL","All infants in this group will get access to Pasteurised donor human milk (PDHM) as supplementary nutrition. PDHM will be made available to the intervention group from the time of randomisation until day 5 of life. Families will be provided with a sufficient supply of frozen PDHM for home use to ensure an exclusively human milk diet up to day 5 of life if their infant is discharged before day 5. Access to PDHM will cease after 120 hours of life, and the infant will be fed according to standard hospital protocols or as per parent's decision.",[13],"Dietary Supplement: Dietary Supplement: PDHM Pasteurised Donor Human Milk",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","ACTIVE_COMPARATOR","All infants in this group will receive the standard care as per local unit policy, including supplemental nutrition (e.g. infant cow's milk formula or IV fluids) as recommended by the treating clinician",[19],"Other: Standard care Cow's milk based formula",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Standard care Cow's milk based formula","Standard hospital care would be given as as per local unit policy at the site.",[15],[26],"Standard Care_Formula milk",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Dietary Supplement: PDHM Pasteurised Donor Human Milk","PDHM will be given to infants randomised to the intervention group",[9],[33],"PDHM_Donor milk",[35],{"name":36,"affiliation":37,"role":38},"Jennifer Koplin, PhD","Child Health Research Centre, University Of Queensland","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","061+0400032577",null,"j.koplin@uq.edu.au",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Vanessa Clifford, PhD","061+0437 527 044","VClifford@redcrossblood.org.au",[50,64,70,79],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":43},"Royal Brisbane and Womens Hospital (QLD)","NOT_YET_RECRUITING","Brisbane","Queensland","4010","Australia","AU",{"type":59,"coordinates":60},"Point",[61,62],153.02809,-27.46794,{"lat":62,"lon":61},{"facility":65,"status":52,"city":53,"state":54,"zip":66,"country":56,"countryCode":57,"cosmosGeoPoint":67,"geoPoint":69,"contacts":43},"Greenslope Hospital (QLD)","4101",{"type":59,"coordinates":68},[61,62],{"lat":62,"lon":61},{"facility":71,"status":52,"city":72,"state":73,"zip":43,"country":56,"countryCode":57,"cosmosGeoPoint":74,"geoPoint":78,"contacts":43},"Frances Perry House (VIC)","Melbourne","Victoria",{"type":59,"coordinates":75},[76,77],144.96332,-37.814,{"lat":77,"lon":76},{"facility":80,"status":81,"city":72,"state":73,"zip":43,"country":56,"countryCode":57,"cosmosGeoPoint":82,"geoPoint":84,"contacts":43},"Royal Womens Hospital (VIC)","RECRUITING",{"type":59,"coordinates":83},[76,77],{"lat":77,"lon":76},{"type":86,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[88,90,92,94,96,99,101,103,105],{"name":89,"class":6},"Murdoch Childrens Research Institute",{"name":91,"class":6},"La Trobe University",{"name":93,"class":6},"University of Melbourne",{"name":95,"class":6},"South Australian Health and Medical Research Institute",{"name":97,"class":98},"Australian Red Cross Lifeblood","UNKNOWN",{"name":100,"class":6},"Monash University",{"name":102,"class":98},"The Royal Women Hospital",{"name":104,"class":98},"Frances Perry House (Ramsay Health)",{"name":106,"class":98},"Ramsay Hospital Research Foundation","100592413","phase-4-pasteurised-donor-human-milk-supplementation-for-term-babies-100592413",false,"NCT06993103","Pasteurised Donor Human Milk Supplementation for Term Babies","A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.","PRESENT","Inclusion Criteria:\n\nEach participant must meet all the following criteria to be enrolled in this trial:\n\n* Mother is \\>18 years at the time of consent\n* Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes)\n* Mother intends to breastfeed for at least 6 weeks at the time of consent.\n* Infant is born at ≥ 37 weeks and weighs \\> 2.5kg\n* Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth.\n* Parent\u002Fs provide\u002Fs a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.\n\nExclusion Criteria:\n\nMother\u002Finfant pairs meeting any of the following criteria will be excluded from the trial:\n\n* Multiple pregnancy\n* Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy\n* Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and\u002For requiring immediate care in a neonatal unit (e.g., congenital heart disease).\n* Infant has received infant formula prior to randomisation.\n* Infant admitted to neonatal intensive care prior to randomisation.\n* More than 48 hours old at the time of recruitment","ALL","0 Hours","48 Hours",{"count":119,"type":120},1444,"ESTIMATED","INTERVENTIONAL",[123],"PHASE4","PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy.\n\nThere will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \\& 6 weeks and 6 \\& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \\[including anxiety and depression symptoms and health-related quality of life\\] along with infant cow's milk allergy symptoms.",[126,127,128,129,130,131,132],"Neonatal Hypoglycemia","Metabolic Complication","Cows Milk Allergy","Hospital Length of Stay","Neonatal Intensive Care Unit","Breastfeeding","Mental Health Issue",[134,135],"Pasteurised donor human milk","Donor breastmilk","2026-01-29",{"date":138,"type":139},"2026-02-02","ACTUAL",{"date":141,"type":139},"2025-12-04",{"date":143,"type":120},"2028-12",{"name":5,"class":6},4]