Dallas, Texas 75390


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02372136


Primary Contact:

Principal Investigator
Luc P Brion, MD
UT Southwestern Medical Center

Luc P Brion, MD
Phone: 214-648-3903
Email: luc.brion@utsouthwestern.edu


Backup Contact:

Email: mocko.brown@utsouthwestern.edu
Mocko Brown
Phone: 214-648-8534


Location Contact:

Dallas, Texas 75390
United States

luc Brion, MD
Phone: 214-648-3903
Email: luc.brion@utsouthwestern.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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