The CanDo (Canadian Donor Milk) Trial: Pasteurized Human Donor Milk Supplementation in the Well-baby Unit
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.
⁃ Infants admitted to the well-baby unit at Sinai Health whose parent(s) intend to feed parent milk and who require supplementation:
• Infants of gestational/ type 1/ type 2 diabetic mothers
• Infants who are born small for gestational age (SGA) by using a sex-specific reference population and determining if their birth weight falls below the 10th percentile for gestational age
• Infants with a birth weight less than 2.5 kg