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Designing an optimal feeding program for preterm infants is particularly challenging. These infants require individualized feeding plans and frequent medical interventions, and their health status and physical limitations necessitate specialized products. This review highlights the challenges of translating new understandings into practical application and, specifically, the challenges of translating scientific knowledge into available nutritional products that can be used to meet the special needs of preterm infants. All infant formula products are developed for use in a heavily regulated environment, which is not integrated internationally. The regulatory framework for preterm nutrition products can be particularly complex in the areas of composition and the degree of scientific and clinical support required across countries. Registration and approval of products for preterm infants in most countries must address the complexities for a population for which no well-recognized nonclinical safety or efficacy models exist. Mandatory regulatory review for science-based innovative product improvements may require two or more years. In addition, throughout years of development, industry must justify the financial support of programs that serve a small specialty segment of the market. These industry-specific challenges may be neither visible nor appreciated by the general public or health care professionals, and, yet, they are integral to the development process. Effective collaborations among academic scientists, regulatory authorities, and the industry are essential to bring science to the bedside. Without such collaborations, preterm infants, and particularly very low birth weight infants, in the neonatal intensive care unit will not be able to benefit from innovative nutrition interventions designed to improve short- and long-term clinical outcomes., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Objectives: To evaluate the growth, tolerance, and safety of a new ultraconcentrated liquid human milk fortifier (LHMF) designed to provide optimal nutrients for preterm infants receiving human breast milk in a safe, nonpowder formulation., Methods: Preterm infants with a body weight ≤ 1250 g fed expressed and/or donor breast milk were randomized to receive a control powder human milk fortifier (HMF) or a new LHMF for 28 days. When added to breast milk, the LHMF provided ∼20% more protein than the control HMF. Weight, length, head circumference, and serum prealbumin, albumin, blood urea nitrogen, electrolytes, and blood gases were measured. The occurrence of sepsis, necrotizing enterocolitis, and serious adverse events were monitored., Results: This multicenter, third party-blinded, randomized controlled, prospective study enrolled 150 infants. Achieved weight and linear growth rate were significantly higher in the LHMF versus control groups (P = .04 and 0.03, respectively). Among infants who adhered closely to the protocol, the LHMF had a significantly higher achieved weight, length, head circumference, and linear growth rate than the control HMF (P = .004, P = .003, P = .04, and P = .01, respectively). There were no differences in measures of feeding tolerance or days to achieve full feeding volumes. Prealbumin, albumin, and blood urea nitrogen were higher in the LHMF group versus the control group (all P < .05). There was no difference in the incidence of confirmed sepsis or necrotizing enterocolitis., Conclusions: Use of a new LHMF in preterm infants instead of powder HMF is safe. Benefits of LHMF include improvements in growth and avoidance of the use of powder products in the NICU.

Background: Parents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional. Up to one-half of formula-fed infants experience a formula change during the first six months of life., Methods: The objective of this study was to assess discontinuance due to study physician-assessed formula intolerance in healthy, term infants. Infants (335) were randomized to receive either a standard intact cow milk protein formula (INTACT) or a partially hydrolyzed cow milk protein formula (PH) in a 60 day non-inferiority trial. Discontinuance due to study physician-assessed formula intolerance was the primary outcome. Secondary outcomes included number of infants who discontinued for any reason, including parent-assessed., Results: Formula intolerance between groups (INTACT, 12.3% vs. PH, 13.7%) was similar for infants who completed the study or discontinued due to study physician-assessed formula intolerance. Overall study discontinuance based on parent- vs. study physician-assessed intolerance for all infants (14.4 vs.11.1%) was significantly different (P = 0.001)., Conclusion: This study demonstrated no difference in infant tolerance of intact vs. partially hydrolyzed cow milk protein formulas for healthy, term infants over a 60-day feeding trial, suggesting nonstandard partially hydrolyzed formulas are not necessary as a first-choice for healthy infants. Parents frequently perceived infant behavior as formula intolerance, paralleling previous reports of unnecessary formula changes., Trial Registration: clinicaltrials.gov: NCT00666120.

Objectives: A randomized, double-blind, prospective trial assessed effects of different formula levels of polyunsaturated fatty acids on blood phospholipid docosahexaenoic (DHA; 22:6omega3) and arachidonic acids (ARA; 20:4omega6) in term infants at 120 days of age., Methods: Healthy, formula-fed term infants (n = 78) were randomized to 1) routine milk-based formula with 8 mg DHA, 21 mg ARA, 110 mg alpha-linolenic (ALA; 18:3omega3), and 1,000 mg linoleic acids (LA; 18:2omega6) per 100 kcal (Lower-long-chain polyunsaturated fatty acids [LCPUFA]; n = 39) or 2) routine milk-based formula with 17 mg DHA, 34 mg ARA, 85 mg ALA, and 860 mg LA per 100 kcal (Higher-LCPUFA; n = 39). Fatty acid methyl esters from red blood cell (RBC) and plasma phospholipid fractions were assessed using capillary column gas chromatography., Results: Compared with infants fed Lower-LCPUFA formula, the Higher-LCPUFA group had significantly greater percentages of fatty acids as DHA in RBC phosphatidylethanolamine (PE), RBC phosphatidylcholine (PC), total RBC, and plasma phospholipids (P < 0.001). Infants fed Lower-LCPUFA formula had higher percentages of precursor omega6 fatty acids in the desaturation/elongation pathway but lower percentages of ARA (RBC PE, RBC PC, and plasma phospholipid, P < 0.001; total RBC, P = 0.017) compared with the Higher-LCPUFA group., Conclusions: Greater amounts of dietary ALA do not produce as great an increase in DHA in blood lipids as preformed dietary DHA. Infants fed DHA at levels similar to human milk had significantly greater percentage of DHAat 120 days of age compared with the Lower-LCPUFA group despite higher precursor levels of ALA.