protocolSection identificationModule nctId: NCT06315127, orgStudyIdInfo id: 23-0119-A, briefTitle: The CanDo (Canadian Donor Milk) Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2024-11-28, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Mount Sinai Hospital, Canada, class: OTHER, collaborators name: Mitacs, descriptionModule briefSummary: The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units. It aims to explore whether supplementation with donor milk vs formula for infants during the initial hospital stay in a well-baby unit will increase both the exclusivity and duration of breastfeeding at 4 months. The Investigators will also explore whether the type of supplementation will positively affect measures of newborns' health, growth, behavior, feeding efficacy, and parental stress. Each participating infant born to a diabetic mother OR born small for his/her gestational age (\<2500 grams) is assigned at random to 2 groups. The groups are: 1) Donor milk: all babies in this group will receive pasteurized donor milk from a trusted milk bank. 2) Formula: all babies in this group will receive formula as a standard of care., conditionsModule conditions: Small for Gestational Age at Delivery, conditions: Gestational Diabetes, conditions: type1diabetes, conditions: Type2diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Human donor milk, interventions name: Formula, outcomesModule primaryOutcomes measure: Donor milk supplementation and exclusive breastfeeding rate at 4 months, secondaryOutcomes measure: Exploring donor milk supplementation and exclusive or any breastfeeding rate at 1, 2, and 3 months, secondaryOutcomes measure: Exploring donor milk supplementation and breastfeeding self-efficacy scores at 1, 2, 3 and 4 months, secondaryOutcomes measure: Exploring donor milk supplementation and glucose concentrations during hospital stay, secondaryOutcomes measure: Exploring donor milk supplementation and percent weight loss during hospital stay, secondaryOutcomes measure: Exploring donor milk supplementation and the length of hospital stay, secondaryOutcomes measure: Exploring donor milk supplementation and weight measurements, secondaryOutcomes measure: Exploring donor milk supplementation and length measurements, secondaryOutcomes measure: Exploring donor milk supplementation and head circumference measurements, otherOutcomes measure: Exploratory outcome: exploring donor milk supplementation and infant temperament scores, otherOutcomes measure: Exploratory outcome: exploring donor milk supplementation and parent's anxiety, otherOutcomes measure: Exploratory outcome: exploring donor milk supplementation and parent's depression, otherOutcomes measure: Exploratory outcome: exploring donor milk supplementation and maternal cortisol concentrations, eligibilityModule sex: ALL, maximumAge: 2 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Labour and Delivery at Mount Sinai Hospital, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1X5, country: Canada, contacts name: Kim Dart, RN, role: CONTACT, phone: 4165864800, phoneExt: 6825, email: kim.dart@sinaihealth.ca, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Maternal Fetal Medicine and Placenta clinics, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1Z5, country: Canada, contacts name: Natasha Milligan, role: CONTACT, phone: 4165864800, phoneExt: 6419, email: natasha.milligan@sinaihealth.ca, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Placenta Clinic, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1Z5, country: Canada, contacts name: Jennifer Vaughan, role: CONTACT, email: jennifer.vaughan@sinaihealth.ca, geoPoint lat: 43.70011, lon: -79.4163, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-09-11, uploadDate: 2024-03-13T17:34, filename: Prot_000.pdf, size: 425804, hasResults: False