TABLE 5.

Select examples in applying a translational research framework to targeted fortification for VLBW infants

Stage	Examples
T1 Discovery	Examples at the T1 stage include: 1) epidemiologic investigations of variability in milk quality, including macronutrient and micronutrient content, of parental and donor human milk and 2) basic science research to identify promising protein sources for fortification of human milk in VLBW settings.
T2 Human health implications	At the T2 stage, needs include the development of novel approaches to designing ethical clinical trials considering the highly vulnerable population. Examples include: 1) improved technology to enable the use of micro volumes of human milk in research; 2) optimal human milk aliquoting strategies for adequate representativeness with minimal volume in targeted fortification protocols [161]; 3) clinical trial designs that do not entail randomization to known inferior NICU feeding protocols outside of the standard of care; and 4) novel approaches to improving the availability of the birthing parent’s milk to NICU infants.
T3 Clinical and Public Health Implications	At the T3 stage, research examples include: 1) clinical trials examining the optimal human milk nutrient composition according to infant disease state, birth weight, and gestational age; 2) comparative effectiveness research of targeted versus standard fortification protocols according to infant birth weight and gestational age; and 3) patient-centered outcomes research aimed at improving the lactating parent experience in initiating and sustaining milk expression.
T4 Implementation	As targeted fortification becomes more widespread, research needs at the T4 stage include: 1) systematic reviews at regular intervals to inform evidence-based protocols for the nutritional care of VLBW infants [163] and 2) research regarding role delineation and best practices training among NICU dietitians, nurses, lactation consultants, and physicians in supporting diverse populations of lactating parents, managing the provision of banked donor human milk, and implementing evidence-based nutritional care plans for VLBW infants [164,165].
T5 Impact	At the T5 stage, ongoing epidemiologic surveillance is needed to monitor the impact of evolving nutritional care protocols for VLBW infants and identify disparities in implementation of best practices across demographic and racial groups.

NICU, neonatal intensive care unit; VLBW, very low birth weight.