Investigating donor human milk composition globally to develop effective strategies for the nutritional care of preterm infants: Study protocol

Authors: PERRIN, MARYANNE - University Of North Carolina; MANSEN, KIMBERLY - Path; ISRAEL-BALLARD, KIERSTEN - Path; RICHTER, SCOTT - University Of North Carolina; BODE, LARS - University Of San Diego; HAMPEL, DANIELA - University Of California, Davis; Shahab-Ferdows, Setti; Allen, Lindsay - A; COFRE MAGGIO, FRANCISCA - Hospital Dr Sotero Del Rio; NJUGUNA, EMILY - Pumwani Maternity Hospital; TRAN, H - The University Of Ðà N¿ng; WESOLOWSKA, ALEKSANDRA - Medical University Of Warsaw

Submitted to: PLOS ONE
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 3/18/2023
Publication Date: 4/5/2023
Citation: Perrin, M.T., Mansen, K., Israel-Ballard, K., Richter, S., Bode, L., Hampel, D., Shahab-Ferdows, S., Allen, L.H., Cofre Maggio, F., Njuguna, E., Tran, H., Wesolowska, A. 2023. Investigating donor human milk composition globally to develop effective strategies for the nutritional care of preterm infants: Study protocol. PLOS ONE. 18(4). Article e0283846. https://doi.org/10.1371/journal.pone.0283846.
DOI: https://doi.org/10.1371/journal.pone.0283846

Interpretive Summary: Almost 15 million infants are born prematurely each year worldwide, mainly in low and middle-income countries. If the mother’s milk is not available (MOM), the World Health Organization recommends using donor human milk (DHM) that provides benefits such as better protection against necrotizing enterocolitis, a life-threatening intestinal infection. Hence, the use of DHM is increasing also in many low and middle-income countries. However, we only have little knowledge about the nutrient composition of DHM or how it is influenced by milk banking practices, and whether preterm nutrient recommendations are met by DHM with commercially available fortifiers. Thus, we designed a multi-site study with eight geographically diverse milk bank partners in high, middle, and low-income settings that will examine and compare a broad range of nutrients and other bioactive factors in human milk from 600 approved global milk bank donors to create comprehensive, geographically diverse nutrient profiles for DHM. This nutritional database can then be used to evaluate the impact of pooling milk and to identify strategies for milk banks to create more consistent nutrient profiles in DHM. Further, we will evaluate if currently available commercial fortifiers meet nutrient recommendations when used with DHM. The results from this study will help to inform nutritional care worldwide for the growing number of preterm infants that depend on donor human milk.

Technical Abstract: Background. Globally, almost 15 million infants are born prematurely each year, disproportionately affecting low and middle-income countries. In the absence of mother’s milk (MOM), the World Health Organization recommends using donor human milk (DHM) due to its protective effect against necrotizing enterocolitis, a life-threatening intestinal infection. The use of DHM is increasing globally, with many low and middle-income countries integrating donor milk banks into their public health strategies to reduce neonatal mortality, yet very little is known about the nutritional composition of DHM; how composition is influenced by milk banking practices; and whether preterm nutrient recommendations are achieved when DHM is used with commercially available fortifiers. Methods. We designed a multi-site study with eight geographically diverse milk bank partners in high, middle, and low-income settings that will examine and compare a broad range of nutrients and bioactive factors in human milk from 600 approved milk bank donors around the world to create comprehensive, geographically diverse nutrient profiles for DHM. We will then use the nutritional database to simulate the impact of pooling donors to identify effective strategies that can be used by milk banks to create more consistent nutrient profiles in DHM, and we will evaluate whether currently available commercial fortifiers meet nutrient recommendations when used with DHM. Discussion. We expected that results from this study will improve nutritional care globally for the growing number of preterm infants who receive donor human milk. Funding: National Institute of Health (R01HD106391); this funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.