# Freeze-Dried Donor Milk for Fortification of Mother’s Own Milk in Preterm Infants: A Preliminary Observational Study

## TL;DR

Freeze-dried donor milk can safely supplement preterm infants' mother's milk without causing growth issues or complications.

## Contribution

Demonstrates safety and efficacy of freeze-dried donor milk fortifiers in preterm infants compared to bovine-based alternatives.

## Key findings

- No serious adverse events or necrotizing enterocolitis occurred with freeze-dried donor milk fortification.
- Anthropometric outcomes were comparable between freeze-dried donor milk and bovine protein-based fortification.
- Feeding tolerance was excellent across over 3,100 feedings in preterm infants ≥30 weeks gestational age.

## Abstract

Background/Objectives: Freeze-dried high-temperature short-time pasteurized human milk fortifiers offer potential for exclusive human milk feeding in preterm infants while providing necessary nutritional supplementation. However, clinical data on safety, tolerability, and growth outcomes remain limited. This study evaluated donor milk fortification compared to conventional bovine protein-based fortification. Methods: We conducted a prospective non-interventional observational cohort study with a retrospectively matched comparison cohort at University Children’s Hospital of Nuremberg. Preterm infants ≥ 30 weeks gestational age requiring mother’s own milk fortification were included. The exposed cohort (n = 32) received freeze-dried high-temperature short-time pasteurized donor milk fortifier at 1.6–4.8 g/100 mL of mother’s own milk; the matched comparison cohort (n = 32) received bovine protein-based fortifier. Primary outcomes included feeding tolerance, safety parameters, and anthropometric measurements. Cohorts were matched for birth weight (±10%), gestational age (±5 days), and fortified feeding. Results: Baseline characteristics were not significantly different: gestational ages 32.8 ± 1.0 versus 33.0 ± 1.2 weeks; birth weights 1900 ± 380 g versus 1840 ± 370 g. Excellent feeding tolerance was demonstrated across >3100 feedings. No necrotizing enterocolitis, abdominal complications, or serious adverse events occurred. Blood glucose, triglycerides, and urea remained normal. Birth weights, lengths, and head circumferences showed no significant differences. Discharge parameters including weight, length, head circumference, and length of stay were also not significantly different. Conclusions: Freeze-dried human milk fortification demonstrates excellent safety and tolerability in preterm infants ≥ 30 weeks gestational age, achieving anthropometric outcomes not significantly different to bovine protein-based fortification. However, the suboptimal protein-to-energy ratio may limit applicability for very low birth weight infants. Therefore, freeze-dried high-temperature short-time pasteurized human milk fortification is suggested to provide appropriate nutritional supplementation for preterm infants with a birth weight over 1500 g.