Osmolality, osmolarity, and renal solute load of infant formulas.
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Male and female infant baboons were reared from birth to 112 days of age on infant formulas containing concentrations of carrageenan varying from none to 5 times the concentration in commercially available formulas for human infants. Carrageenan content of the formula did not affect weight, characteristics of urine and feces, findinds on physical examination, hematological variables, blood chemical analyses, organ system weights, or the macroscopic and microscopic appearance of the gastrointestinal tract.
The levels of individual proteins and other nitrogen containing substances differ considerably between cow's milk and human milk. Therefore, during manufacture of infant formulas, attempts are made to simulate the protein composition of human milk. However, the composition and nutritional characteristics of human milk protein are incompletely known. In this paper, the protein quality of breast milk protein with and without the non-protein-nitrogen (NPN) substances present in human milk was studied with growing rats and compared to two formulas, one "adapted" commercial infant formula and a suggested further modified, possibly improved, infant formula. Detailed examinations of protein and amino acid composition of the test diets are given. Breast milk protein with added NPN substances showed a lower protein quality than all other test proteins. Breast milk protein without NPN substances and the protein of the suggested infant formula were of similar quality while the protein of the commercial adapted formula was significantly better than all other test proteins. The use of rat growth assays in the evaluation of protein quality of infant formulas is discussed.
INTRODUCTION: Mother's milk is the gold standard for feeding newborns. Despite lactation support while in hospital, supplementation rates remain high in Canadian well-baby units at 35-50%. When supplementation is needed, the choice between formula milk and pasteurised human donor milk (donor milk) remains uncertain with a lack of clinical trials to inform this practice. This study aims to compare the effect of supplementing mother's milk with donor milk versus formula in infants at higher risk for supplementation (infants of diabetic mothers, infants born small for gestational age or with a birth weight less than 2.5 kg and late preterm infants born between 350/7 and 366/7 weeks gestation). METHODS AND ANALYSIS: This is an ongoing, open-label, single-centre, randomised controlled trial conducted at Mount Sinai Hospital, Toronto, Canada. A total of 112 infants (56 per group) will be randomised to receive donor milk or infant formula as a supplement to mother's milk during their initial hospital stay, when supplementation is deemed necessary by the family and/or healthcare team. The primary outcome is exclusive human milk feeding at 4 months of age. Secondary outcomes include any or exclusive human milk feeding at 1, 2 and 3 months; infant growth and health indicators and breastfeeding self-efficacy. Exploratory outcomes encompass infant temperament; parental mental health (assessed using the State-Trait Anxiety Inventory and Edinburgh Postnatal Depression Scale); milk cortisol concentrations; and informal milk sharing comparing donor milk and formula supplementation. Follow-up includes monthly telephone assessments and a virtual or in-person visit at 4 months post partum. Data will be analysed using intention-to-treat principles. ETHICS AND DISSEMINATION: The CanDo trial has received ethics approval from the Mount Sinai Hospital Research Ethics Board and the University of Toronto. Results will be disseminated through peer-reviewed journals, conference presentations and stakeholder engagement with hospital and public health decision-makers. Findings will address a critical evidence gap regarding the use of donor milk supplementation in well-baby units and may inform future clinical practice and policy in newborn feeding. TRIAL REGISTRATION NUMBER: NCT06315127.