310 - Energy and Nutrient Dense Formula: A Systematic Review of Clinical Trial Evidence

Publication Number: 3299.310

Nana Ama Owusua. Owusu, SUNY Downstate Health Sciences College of Medicine, Brookyln, NY, United States; Rabia Aggarwal, SUNY Downstate, BROOKLYN, NY, United States; Chad E. Ehimhen, State University of New York Downstate Medical Center College of Medicine, Brooklyn, NY, United States; Christina P.M. Wells, State University of New York Downstate Medical Center College of Medicine, Brooklyn, NY, United States; Maad Galal, Yale School of Medicine, New Haven, CT, United States; Kyle J.. Hampson, Nutricia North America, Brooklyn, NY, United States; Venus Kalami, Nutricia North America / Danone, Campbell, CA, United States; Lawrence Fordjour, State University of New York Downstate Medical Center College of Medicine, Brooklyn, NY, United States; Thomas Wallach, State University of New York Downstate Medical Center College of Medicine, Brooklyn, NY, United States

Background: Energy and nutrient dense formula (ENDF) is a specialized term infant formula designed to promote catch up growth in infants and toddlers up to 18 months of age with or at risk of growth failure, malnutrition, increased energy requirements, or fluid restriction due to medical conditions. ENDF is nutritionally complete, ready-to-feed and provides higher calories (30 calories/ounce), protein (2.6 grams/100 kilocalories), and lower osmolality (360 milliOsmoles/liter) when compared to other term infant formulas at similar concentrations. In response to increased clinical use of ENDF, we utilized the PRISMA guidelines to conduct a systematic review of clinical trials utilizing ENDF.

Objective: This study aims to synthesize literature from clinical trials on ENDF to evaluate the effects of ENDF on growth, tolerance, nitrogen balance, and safety in infants.

Design/Methods: Two independent teams of investigators searched PubMed, Embase, and Cochrane Library databases. Searches were conducted using standardized terminology related to energy and nutrient dense formula, growth, tolerance, and nitrogen balance. Studies were screened based on inclusion and exclusion criteria, which included: a randomized, controlled study design, use of ENDF in the infant population, and publication of the full text article in English. Data was extracted from the included articles and evaluated. A risk of bias assessment was also performed using the Risk of Bias Assessment 2 (RoB 2) tool for each included study.

Results: One hundred and sixty-four studies were identified from the databases. Seventy-one duplicates were removed, resulting in 93 unique citations. Ten studies met the criteria to be included in the systematic review (Figure 1). The main outcomes evaluated across the studies are summarized in Table 1. The outcomes included were growth (6 studies), formula tolerance (7 studies), nitrogen balance (5 studies), and safety (2 studies). These studies demonstrated that ENDF promotes growth in various patient populations, is well tolerated (especially with gradual introduction in younger patients), and promotes a positive nitrogen balance. In studies that reported safety events, there were no serious safety events related to ENDF reported.

Conclusion(s): ENDF is a safe and well-tolerated formula that promotes growth and positive nitrogen balance in term infants.

PRISMA Flow Diagram for Inclusion/Exclusion of Studies
ENDF SR PRISMA Flow Diagram for Abstract FINAL.pdf

Summary of Studies Included in the Systematic Review
Abstract Summary Table FINAL.pdf