676 - Randomized controlled trial of target vs. modified standard human milk fortification on growth and neurocognitive development in very low birth weight infants

Publication Number: 676.6467

Corinna Mirjam. Gebauer, University of Leipig Medical Center, Leipzig, Sachsen, Germany; Annett Blaeser, Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Leipzig, Leipzig, Sachsen, Germany; Niels Rochow, Paracelsus Medizinische Privatuniversität, Klinikum Nürnberg, Nürnberg, Bayern, Germany; Christoph Fusch, Paracelsus Medical School Nuremberg, Nuremberg, Bayern, Germany; Walter Mihatsch, Ulm University and Balingen Pediatric Hospital, Schwaebisch Hall, Baden-Wurttemberg, Germany; Ulrich H.. Thome, Universitätsklinikum Leipzig, Leipzig, Sachsen, Germany; Rudolf Ascherl, University of Leipzig, Leipzig, Sachsen, Germany

Background: Human milk (HM) is the optimum nutrition for term infants. Its unique properties contribute to postnatal protection, maturation, and long-term programming of various organ systems.

Objective: However, the high energy and nutrient requirements of preterm infants require fortification of HM. This trial aims to study whether individualized target fortification (TF) or a modified standardized fortification (MSF) should be recommended.

Design/Methods: In a double-blind randomized controlled trial, VLBW infants, 24.0/7-31+6/7 weeks of gestation (GA), on a HM (mother’s own milk and donor milk) diet were randomly assigned to MSF or TF from birth to 36 weeks of postmenstrual age (PMA) with multi-component standard fortifier and protein supplement based on cow's milk. In the MSF group, infants received a standard fortifier (1.1g protein), protein supplement (1g) and MCT oil (0.45g) per 100mL HM. In TF group, infants received a standard fortifier and, based on HM analysis, additional protein supplement and MCT oil. Target concentration of protein was 3.0 g/100 ml in infants < 34 weeks PMA and 2.6 g/100 ml in infants ≥ 34 weeks PMA, target concentration for fat was 4.5 g/100 ml. All HM samples were analyzed daily by mid-infrared spectrometry. Primary outcome was weight gain, secondary outcomes were anthropometry, plasma amino acid levels, cranial ultrasound, and Bayley Scales of Infant Development (3rd version).

Results: 106 out of 110 enrolled infants met inclusion criteria. The protein intake received by the MSF group was higher protein beyond 34 weeks PMA compared to the TF group. There was no significant difference between MSF and the TF infants regarding weight, length, and head circumference at 36 weeks PMA. There was no significant difference for blood urea nitrogen, plasma amino acid, urinary calcium and phosphate and no significant differences in cognitive, language or motor scores at 24 months corrected age. In 66 infants, tyrosine levels exceeded 200 µmol/l, including 12 infants (MSF N=5, TFO N=7) above 400 µmol/l.

Conclusion(s): VLBW infants who received MSF when compared with TF for protein and fat, did not have a different in hospital growth up to 36 weeks PMA nor neurocognitive development at 24 months PMA. However 11% (N=12) of all infants had unphysiological high tyrosine levels, which were likely caused by protein fortification. Further research is needed to investigate this result in more detail.