Target Versus Modified-Standard Fortification of Human Milk and Growth of Very Low Birth Weight Infants: A Double-Blind Randomized Trial
6 affiliations
- 1Division of Neonatology, Department of Pediatrics, University of Leipzig Medical Center, Liebigstraße 20a, 04103 Leipzig, Germany
- 2Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Carl Gustav Carus, 01307 Dresden, Germany
- 3Department of Pediatrics, Paracelsus Medical University, 90471 Nuremberg, Germany
- 4Department of Pediatrics, University Medicine Rostock, 18057 Rostock, Germany
- 5Department of Pediatrics, McMaster University, Hamilton, ON L8S 4K1, Canada
- 6Department of Pediatrics, Ulm University, 89075 Ulm, Germany
Abstract
Background/Objectives: Individualized (“target”) fortification of human milk is promoted to improve growth and subsequent neurodevelopment in very low birth weight (VLBW) infants, because standard fortifiers may not provide sufficient protein given the considerable intra- and interindividual variability of human-milk composition. We compared modified-standard fortification (MSF), an optimized high-protein standard regimen, with high-protein target fortification (TFO). Methods: In a single-center, double-blind randomized trial, VLBW infants (24 + 0 – 31 + 6 weeks) receiving 100 mL/kg/d of standard fortified human milk were randomized to MSF (protein and medium-chain triglycerides added to standard fortifier) or TFO until 36 weeks postmenstrual age (PMA). The primary outcome was weight-gain velocity from randomization to 36 weeks PMA; the trial was powered to detect a difference of 0.666 standard deviations. Results: Weight-gain velocity did not differ between the groups (MSF n = 54, TFO n = 52; MSF − TFO − 0.18 g/kg/d, 95% CI −1.02 to +0.67, p = 0.68), nor did anthropometry, z-scores, skinfold thickness or cranial widths at 36 weeks PMA, or Bayley-III scores at 24 months. Conclusions: Compared with optimized high-protein standard fortification, high-protein target fortification did not improve growth or neurodevelopmental outcomes.
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BibTeX
@article{gebauer2026target,
title = {{Target Versus Modified-Standard Fortification of Human Milk and Growth of Very Low Birth Weight Infants: A Double-Blind Randomized Trial}},
author = {Corinna M. Gebauer and Rudolf G. Ascherl and Nadine Stamm and Julia Wiegand and Marina Stopsack and Annett Blaeser and Niels Rochow and Christoph Fusch and Walter A. Mihatsch and Ulrich H. Thome},
journal = {Nutrients},
year = {2026},
month = oct,
doi = {10.3390/nu18193241},
url = {https://europepmc.org/article/PMC/PMC13667121},
note = {CC BY},
}
RIS
TY - JOUR
TI - Target Versus Modified-Standard Fortification of Human Milk and Growth of Very Low Birth Weight Infants: A Double-Blind Randomized Trial
AU - Corinna M. Gebauer
AU - Rudolf G. Ascherl
AU - Nadine Stamm
AU - Julia Wiegand
AU - Marina Stopsack
AU - Annett Blaeser
AU - Niels Rochow
AU - Christoph Fusch
AU - Walter A. Mihatsch
AU - Ulrich H. Thome
PY - 2026
DA - 2026/10/01
JO - Nutrients
DO - 10.3390/nu18193241
UR - https://europepmc.org/article/PMC/PMC13667121
AB - Background/Objectives: Individualized (“target”) fortification of human milk is promoted to improve growth and subsequent neurodevelopment in very low birth weight (VLBW) infants, because standard fortifiers may not provide sufficient protein given the considerable intra- and interindividual variability of human-milk composition. We compared modified-standard fortification (MSF), an optimized high-protein standard regimen, with high-protein target fortification (TFO). Methods: In a single-center, double-blind randomized trial, VLBW infants (24 + 0 – 31 + 6 weeks) receiving 100 mL/kg/d of standard fortified human milk were randomized to MSF (protein and medium-chain triglycerides added to standard fortifier) or TFO until 36 weeks postmenstrual age (PMA). The primary outcome was weight-gain velocity from randomization to 36 weeks PMA; the trial was powered to detect a difference of 0.666 standard deviations. Results: Weight-gain velocity did not differ between the groups (MSF n = 54, TFO n = 52; MSF − TFO − 0.18 g/kg/d, 95% CI −1.02 to +0.67, p = 0.68), nor did anthropometry, z-scores, skinfold thickness or cranial widths at 36 weeks PMA, or Bayley-III scores at 24 months. Conclusions: Compared with optimized high-protein standard fortification, high-protein target fortification did not improve growth or neurodevelopmental outcomes.
SN - 2072-6643
ER -