Effects of Amino-acids based fortifier in preterm infants – An open label, observational study

Background: Preterm infants have elevated protein needs for optimal growth and development; However, current bovine milk-based fortifiers are associated with feed intolerance and necrotising enterocolitis (NEC). An amino acid-based fortifier (AABF) can enhance protein absorption and tolerance in preterm infants. This study evaluates the safety and efficacy of an amino-acid-based fortifier in improving growth outcomes in preterm neonates. Methods: Preterm infants with a birth weight < 2000 g and/or gestational age < 32 weeks were prospectively observed in this single-centre, open-label study. Following the establishment of enteral feeds at 100 ml/kg/day, an amino acids-based forifier (Human Milk Fortifier (HMF) -ADVANCE) was introduced and maintained until neonatal intensive care unit (NICU) discharge. The primary outcome was assessment of daily weight gain, with secondary outcomes including weekly gains in length and head circumference and the occurrence of feed intolerance was also considered for assessment. Results: A total of 25 preterm infants (12 males and 13 females) with an average birth weight of 1204.62 ± 48.9 grams and a mean gestational age of 31.33 ± 3.4 weeks were enrolled in the study. At the end of the study period, the observed growth outcomes included a mean weight gain of 21.34 ± 3.41 grams per day, a mean head circumference increase of 0.92 ± 0.32 cm per week, and a mean length increase of 0.9 ± 0.13 cm per week. There were no instances of feed intolerance or NEC during the study, and none of the infants required discontinuation of fortification before discharge from the NICU. Conclusion: Fortification with an amino-acid-based fortifier in preterm infants demonstrated positive growth outcomes with optimal weight gain, length gain, and head circumference growth. No infants exhibited feeding intolerance, indicating good safety and tolerance. These findings suggest that AABF is an effective fortification strategy for preterm neonates.