nctId: NCT06315127 id: 23-0119-A briefTitle: The CanDo (Canadian Donor Milk) Trial overallStatus: RECRUITING date: 2023-11-28 date: 2024-11-28 date: 2025-03-31 date: 2024-03-18 date: 2024-03-18 name: Mount Sinai Hospital, Canada class: OTHER name: Mitacs 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. conditions: Small for Gestational Age at Delivery conditions: Gestational Diabetes conditions: type1diabetes conditions: Type2diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 112 type: ESTIMATED name: Human donor milk name: Formula measure: Donor milk supplementation and exclusive breastfeeding rate at 4 months measure: Exploring donor milk supplementation and exclusive or any breastfeeding rate at 1, 2, and 3 months measure: Exploring donor milk supplementation and breastfeeding self-efficacy scores at 1, 2, 3 and 4 months measure: Exploring donor milk supplementation and glucose concentrations during hospital stay measure: Exploring donor milk supplementation and percent weight loss during hospital stay measure: Exploring donor milk supplementation and the length of hospital stay measure: Exploring donor milk supplementation and weight measurements measure: Exploring donor milk supplementation and length measurements measure: Exploring donor milk supplementation and head circumference measurements measure: Exploratory outcome: exploring donor milk supplementation and infant temperament scores measure: Exploratory outcome: exploring donor milk supplementation and parent's anxiety measure: Exploratory outcome: exploring donor milk supplementation and parent's depression measure: Exploratory outcome: exploring donor milk supplementation and maternal cortisol concentrations sex: ALL maximumAge: 2 Hours stdAges: CHILD facility: Labour and Delivery at Mount Sinai Hospital status: RECRUITING city: Toronto state: Ontario zip: M5G 1X5 country: Canada name: Kim Dart, RN role: CONTACT phone: 4165864800 phoneExt: 6825 email: kim.dart@sinaihealth.ca lat: 43.70011 lon: -79.4163 facility: Maternal Fetal Medicine and Placenta clinics status: RECRUITING city: Toronto state: Ontario zip: M5G 1Z5 country: Canada name: Natasha Milligan role: CONTACT phone: 4165864800 phoneExt: 6419 email: natasha.milligan@sinaihealth.ca lat: 43.70011 lon: -79.4163 facility: Placenta Clinic status: RECRUITING city: Toronto state: Ontario zip: M5G 1Z5 country: Canada name: Jennifer Vaughan role: CONTACT email: jennifer.vaughan@sinaihealth.ca lat: 43.70011 lon: -79.4163 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