Abstract
In 3 of 5 collaborating centres, two clinical trials comparisons are being made between infants randomly assigned to a preterm formula (PTF) or banked milk (BBM) fed as sole diets or in conjunction with maternal milk. (n=200 at second interim analysis). BBM fed infants showed: 1. increased incidence of: severe hyponatraemia (Na <126 mmol/1, p <0.05), radiological and biochemical evidence of rickets of prematurity (hypophosphataemia and higher alkaline phosphatase p <0.01) and riboflavin deficiency (erythrocyte glutathione reductase activation coefficient >1.3, p<0.01); 2. higher peak plasma bilirubin and more prolonged hyperbilirubinaemia (p<0.01), 3. higher plasma prolactin and growth hormone concentration (p<0.01). PTF fed infants showed 1. increased: growth rates (reported elsewhere), gastric pooling (p<0.01) and latent systemic anaphylactic sensitisation to cows milk (basophil histamine release to cowsmilk and anti IgE challenge, p<0.01); 2. faster postnatal fall in plasma IgG and rise in IgM (p<0.05); 3. lower plasma calcium (week 1) and potassium (p<0.02) 4. higher platelet count (p<0.05) and plasma concentration of some amino acids, notably threonine (p<0.0001). We conclude that patterns of short term response to diet are complex and cannot be used to predict an overall clinical benefit of a feeding regime - their clinical significance can be assessed only by follow up studies, the principle concern of these trials.
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A, L., Tj, C., Sm, G. et al. II. Multicentre clinical trial of diets for low birthweight infants: interim analysis of short term clinical and biochemical effects of diet. Pediatr Res 18, 803 (1984). https://doi.org/10.1203/00006450-198408000-00070
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DOI: https://doi.org/10.1203/00006450-198408000-00070