TABLE 6.

Select examples in applying a translational research framework to provision of human milk to small sick newborns in low- and middle-income countries

Stage	Examples
T1 Discovery	At the T1 stage, research is needed to assess variation in composition of donor human milk from the birthing parent in low-, middle-, and high-income settings; to characterize how quality of donor human milk varies according to milk banking screening, pooling, pasteurization, storage, and delivery methods specific to human (not bovine) milk or alternative low-cost treatment systems; and to develop low-cost, point-of-care DHM screening mechanisms.
T2 Human health implications	At the T2 stage, there is need for innovative research to support long-term lactation for birthing parents of SSNBs. Examples include: 1) development of LMIC-appropriate hospital-grade breast pumps; 2) development of improved technologies for feeding SSNBs expressed human milk in LMIC settings that optimize quality and composition of human milk reaching the gut of SSNB (and reduce fat loss due to adhesion to tubing); and 3) developing respectful models of care for the birthing parent-SSNB dyad through feasibility studies such as an enhanced training model for hospital staff to provide specialized lactation support, or a family participatory care model, or a peer group support model. Innovative research is needed to adapt human milk bank systems to LMIC settings, including development and evaluation of LMIC-appropriate point-of-care donor screening mechanisms, and DHM processing and storage protocols, and the development and pilot testing of models for integrating LMIC-specific human milk bank systems into newborn care and human milk feeding promotion.
T3 Clinical and Public Health Implications	At the T3 stage, research includes clinical trials in LMIC settings of the most promising technology innovations and maternity interventions to emerge from T2 research aimed at improving lactation support, exclusive human milk feeding at discharge, and appropriate use of DHM and assessing reduction in neonatal morbidity and mortality and reduced length of hospital admission.
T4 Implementation	At the T4 stage, research needs include development of “best in practice” guidelines for SSNB care in LMIC settings and implementation science research. Examples of DHM research needs include: 1) determining motivations, barriers, and trade-offs for donating, selling, sharing, and receiving DHM in LMIC settings; 2) development of evidence-based global standards for ethical, safe, and effective human milk banking operations; and 3) systematic reviews and analyses on the requirements and cost-effectiveness of an LMIC-appropriate comprehensive HMB model to inform sustainable expansion.
T5 Impact	At the T5 stage, ethical epidemiologic surveillance frameworks are needed to monitor lactation support to the birthing parent, the human milk donor, and human milk recipient, with consideration for vulnerability, equity, and fairness; respect for autonomy; and human rights. Examples of needed epidemiologic surveillance include: 1) global feeding practices of SSNBs by conducting a multi-country assessment; 2) improving routine indicators to enable monitoring of lactation support, inpatient SSNB feeding practices, and neonatal health outcomes; 3) document expansion of human milk banks in LMIC settings; utilization of standards; and impact on human milk intake, length of hospital stay, and ultimately, the impact on neonatal health, morbidity, and mortality; and iv) ongoing epidemiologic surveillance of geographic, economic, and racial inequities in SSNBs receiving human milk.

DHM, donor human milk; HMB, human milk bank; LMIC, low- or middle-income country; SSNB, small and sick newborn.