title: Feeding the preterm infant: opportunities and challenges of bringing science to the bedside.
abstract: 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.
authors: Department of Pediatrics, University of Florida, Gainesville, FL, USA.
authors: Josef
authors: J
authors: Neu
authors: Cristine L
authors: CL
authors: Bradley
authors: Zong-Yi
authors: ZY
authors: Ding
authors: Hugh N
authors: HN
authors: Tucker
authors: Carol Lynn
authors: CL
authors: Berseth
mesh_terms: D002986:Clinical Trials as Topic; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D003299:Cooperative Behavior; D063427:Food Quality; D014943:Global Health; D033161:Government Regulation; D006801:Humans; D007224:Infant Care / Q000379:methods / Q000592:standards; D041943:Infant Formula / Q000331:legislation & jurisprudence / Q000592:standards; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D007234:Infant, Premature / Q000502:physiology*; D038622:Internationality; D057170:Translational Research, Biomedical