610 - Novel lyophilized fortifier based on human milk for preterm infants achieves rapid early feeding advancement, growth like in utero, and desired neonatal outcomes

Publication Number: 610.5969

Niels Rochow, Paracelsus Medizinische Privatuniversität, Klinikum Nürnberg, Nürnberg, Bayern, Germany; Katja M.. Knab, Klinikum Nuernberg, Campus Sued, Nuernberg, Bayern, Germany; Jasper L.. Zimmermann, Klinikum Nürnberg, Nürnberg, Bayern, Germany; Kerstin Simon, Klinikum Nürnberg Süd, Nürnberg, Bayern, Germany; Stefan Schäfer, Klinikum Nürnberg - Paracelsus Medizinische Universität, Nürnberg, Bayern, Germany; Stephanie Lohmüller-Weiss, Paracelsus Medical University Nürnberg, Nürnberg, Bayern, Germany; Anastasia Meis, Klinikum Nuremberg, Nuremberg, Bayern, Germany; Julia Welsch, Klinik für Kinder-und Jugendmedizin Nürnberg, Nürnberg, Bayern, Germany; Simone Schäfer, Klinik für Kinder- und Jugendmedizin Klinikum Nürnberg, Nürnberg, Bayern, Germany; Christoph Fusch, Paracelsus Medical School Nuremberg, Nuremberg, Bayern, Germany

Background: An exclusively human milk (HM) diet is recommended for preterm infants due to its high feeding tolerance, low risk of necrotizing enterocolitis (NEC), sepsis, and mortality, as well as its association with improved neurodevelopmental outcomes. A novel lyophilized fortifier (Lyo), based on human milk, was developed to supplement nutrients without replacing the mother’s milk, thereby preserving the natural bioactive components of breast milk. Additionally, the Lyo fortifier includes a broad spectrum of complex human milk oligosaccharides.

Objective: To compare the outcomes of preterm infants fed with the Lyo fortifier to results from previous studies using different fortification methods.

Design/Methods: Preterm infants born at < 32 weeks gestation with a birth weight (BWT) < 750g were assigned to receive either the Lyo fortifier (HM-based), a liquid HM-based fortifier (LF), or a cow's milk (CM)-based fortifier. Infants with a BWT ≥750g received only the Lyo fortifier. The final formulation of Lyo provides, per 100mL, 1.6g protein, 1.8g carbohydrate, 0.7g fat, and optimized minerals, phosphates, and electrolytes. Both HM-based fortifiers were supplemented with vitamins. All infants received target-fortified breast milk adjusted with carbohydrate, protein, and fat modules based on two milk analyses per week.

Results: The study included n=68 infants fed Lyo breast milk and n=99 control infants. Preterm with BWT < 750g were Lyo (N=6, BWT 580±90g), LF (N=47, BWT 620±110g, GA 25.8±1.8 weeks), and CM (N=52, BWT 610±100g, GA 25.3±1.7 weeks) groups. Infants achieved 120 mL/kg/d enteral intake by day of life: Lyo (9±4 days), LF (10±7 days), and CM (15±13 days). Severe morbidities were lower in the HM-fortified groups compared to the CM-fortified group (severe BPD: 17% vs. 20% vs. 30%; ROP stages 3-5: 16% vs. 20% vs. 27%; late-onset sepsis: 17% vs. 40% vs. 70% (Lyo vs. LF vs. CM)). Weight gain was higher in the Lyo group (20.5±2.9 g/kg/d) compared to the CM group (19.8±3.3 g/kg/d) and the control group (18.3±2.8 g/kg/d).
Preterm infants with BWT ≥750g (N=62) had an average BWT of 1330±350g and GA of 29.2±1.8 weeks. They achieved 120 mL/kg/d enteral intake by day of life 6±4. Feeding tolerance was excellent, with no NEC, severe/moderate BPD, or severe ROP observed. Weight gain velocity was 17.9±2.7 g/kg/d.

Conclusion(s): The novel lyophilized fortifier based on human milk shows promise as it maintains the benefits of maternal milk, with enhanced feeding tolerance, growth, and neonatal outcomes. A multicenter RCT is currently underway, comparing Lyo and CM fortifiers in infants fed either their mother’s milk or donor milk.