Adjusted versus Targeted Fortification in Extremely Low Birth Weight Preterm Infants: Fortin Study. A Randomized Clinical Trial.

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Abstract
Fortified human milk is the first choice for preterm infants. Although individualized fortification is recommended, the optimal method for this population remains uncertain. We conducted a comparative study assessing the growth effects of adjusted (AF) and targeted fortification (TF) in extremely low birth weight (ELBW) infants. This single-center, randomized, controlled clinical trial was conducted at a tertiary neonatal unit in Spain. Eligible participants were premature infants with a birthweight <1000g exclusively fed with human milk. A total of 38 patients were enrolled, 15 of them randomised to AF group and 23 to TF group. AF was based on BUN concentration and TF on human milk analysis. The primary outcome was weight gain velocity (g/kg/day).No significant differences were found in weight gain velocity at 28 days, at 36 weeks of postmenstrual age, at discharge nor during intervention. Protein intake was significantly higher in AF group (5.02 g/kg/day vs 4.48 g/kg/day, p= 0.001). No differences were found in lipids, carbohydrates and energy intake; neither in weight z score change between the different time points; nor in length and head circumference growth. Both AF and TF are comparable methods of fortification and provide appropriate growth rate in ELBW infants.

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