Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
Individualizing and Optimizing Nutrition to Prevent Metabolic Syndrome and To Improve Neurodevelopment in Preterm and Small for Gestational Age Infants
In preterm infants fed human milk, milk needs to be fortified to meet nutrient
recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on
daily human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on
growth rate and serum analyses).
The first specific aim will determine whether individualized and optimized nutrition during
hospitalization results in improved growth in the neonatal intensive care unit (NICU) in
extremely low gestational age (GA) neonates (ELGANs, <29 weeks) and in small for GA (SGA,
birth weight <10th percentile for GA) preterm infants compared with optimized nutrition.
The second specific aim will determine whether individualized and optimized nutrition in the
NICU improves neurodevelopmental outcomes (acquisition of development milestones) and
reduces the risk of disproportionate growth (i.e., excess fat) in the NICU and findings
suggestive of metabolic syndrome in the first 3 years of life.
1. Primary hypothesis: In preterm infants (GA <29 weeks or GA <35 weeks and SGA)
individualized and optimized nutrition will increase velocity of growth (weight gain
velocity by 2 g x kg-1 x day-1 and length velocity by 0.2 cm per week) from birth to 36
weeks of postmenstrual age (GA plus postnatal age) in comparison with optimized
2. Secondary hypotheses: Individualized and optimized nutrition will improve
neurodevelopmental outcome and reduce the risk of disproportionate growth (excess fat)
in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.
Double-blinded randomized controlled trial (RCT): After consent, 150 neonates will be
randomized to one of two groups.
Study intervention: Patients will be randomized to either:
1. Control: optimized nutrition: Milk fortification will be based on current
recommendations and optimized by adjustment of nutrients once a week based on blood
levels of urea nitrogen and albumin and velocity of growth (weight and length).
2. Intervention: Individualized and optimized nutrition: Milk fortification will be
optimized as in control neonates. In addition, nutrition will be individualized every
day. Milk fortification will be adjusted based on daily measurements of macronutrients
in human milk using near-infrared analysis.
Randomization will be done by computer provided by a statistician using random block
allocation and stratification by GA and size for age (AGA 23-28 weeks, SGA 23-28 weeks and
SGA 29-34 weeks). Twins and multiples will be randomized to the same arm of the study.
Infant, Premature, Diseases, Infant, Small for Gestational Age
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center, Children's Medical Center Dallas, The Gerber Foundation