Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants



Status:Active, not recruiting
Healthy:No
Age Range:Any
Updated:2/8/2019
Start Date:January 2016
End Date:December 31, 2022

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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.

Hypotheses:

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) or discharge (whichever comes first)
in comparison with optimized nutrition.

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.

Study design:

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.

Inclusion Criteria:

- Preterm infants <29 weeks GA and SGA infants <35 weeks GA born at Parkland Health and
Hospital System

- Maternal plan to breastfeed or to use milk from the donor milk bank

- From birth to 1 week of life

Exclusion Criteria:

- Patients on comfort care only

- Patients with major congenital abnormalities

- Patients who are too unstable for the first 7 days to have an accurate length
measurement
We found this trial at
1
site
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Luc P Brion, MD
Phone: 214-648-3903
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Dallas, TX
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