508237
research-article2013
JHLXXX10.1177/0890334413508237Journal of Human LactationBrownell et al
Original Research
Donor Human Milk Bank Data Collection in North America: An Assessment of Current Status and Future Needs
Journal of Human Lactation XX(X) 1–7 © The Author(s) 2013 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0890334413508237 jhl.sagepub.com
Elizabeth A. Brownell, MA, PhD1, Mary M. Lussier, RN, BSN, IBCLC1, Victor C. Herson, MD1, James I. Hagadorn, MD, MS1, and Kathleen A. Marinelli, MD, IBCLC, FABM, FAAP1 Abstract Background: The Human Milk Banking Association of North America (HMBANA) is a nonprofit association that standardizes and facilitates the establishment and operation of donor human milk (DHM) banks in North America. Each HMBANA milk bank in the network collects data on the DHM it receives and distributes, but a centralized data repository does not yet exist. In 2010, the Food and Drug Administration recognized the need to collect and disseminate systematic, standardized DHM bank data and suggested that HMBANA develop a DHM data repository. Objective: This study aimed to describe data currently collected by HMBANA DHM banks and evaluate feasibility and interest in participating in a centralized data repository. Methods: We conducted phone interviews with individuals in different HMBANA milk banks and summarized descriptive statistics. Results: Eight of 13 (61.5%) sites consented to participate. All respondents collected donor demographics, and half (50%; n = 4) rescreened donors after 6 months of continued donation. The definition of preterm milk varied between DHM banks (≤ 32 to ≤ 40 weeks). The specific computer program used to house the data also differed. Half (50%; n = 4) indicated that they would consider participation in a centralized repository. Conclusion: Without standardized data across all HMBANA sites, the creation of a centralized data repository is not yet feasible. Lack of standardization and transparency may deter implementation of donor milk programs in the neonatal intensive care unit setting and hinder benchmarking, research, and quality improvement initiatives. Keywords breastfeeding, human milk, Human Milk Banking Association of North America, milk bank, public health surveillance
Well Established Data regarding Human Milk Banking Association of North America (HMBANA) milk banks are not publicly available. The Food and Drug Administration recognized the need to develop a centralized registry to collect and disseminate standardized data; this registry does not exist.
Newly Expressed HMBANA-affiliated milk banks do not collect consistent data regarding milk donors and milk bank operations. Lack of standardization and transparency may deter implementation of donor milk programs in the neonatal intensive care unit setting and hinder benchmarking, research, and quality improvement initiatives.
Background The health benefits of human milk for the very low birth weight (VLBW) population (≤ 1500 grams) are well
documented.1-24 However, expressing milk for a baby in the neonatal intensive care unit (NICU) can be challenging.25-27 As a result, mothers of VLBW infants are less likely to initiate milk expression and more likely to discontinue milk expression earlier than mothers of term infants.25,28 The use of donor human milk (DHM) in the NICU setting has allowed VLBW infants to receive the benefits of human milk when their mothers are unable to provide either some or all of the milk they need.17,22 The Surgeon General’s 2010 Call to Action to Support Breastfeeding highlighted the importance of DHM (“Action #12. Identify and address obstacles to 1
The Connecticut Human Milk Research Center, Division of Neonatology, Connecticut Children’s Medical Center, Hartford, CT, USA Date submitted: June 3, 2013; Date accepted: September 17, 2013. Corresponding Author: Elizabeth A. Brownell, The Connecticut Human Milk Research Center, Division of Neonatology, Connecticut Children’s Medical Center, 282 Washington Street, Hartford, CT 06106, USA. Email: [email protected]
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Table 1. Human Milk Banking Association of North America Mission/Goals.33 1. 2. 3. 4. 5. 6. 7. 8.
Ensure quality control of donor human milk banking among member banks through adherence to these mandatory guidelines and periodic inspection of member banks Annually review guidelines for donor milk banking practices in North America Provide a forum for networking among experts in the field on issues relating to donor human milk banking Provide information on the benefits and appropriate uses of banked human milk Communicate among member donor milk banks to assure adequate supplies for all patients Act as a liaison between member institutions and governmental regulatory agencies Advocate for increased use of donor milk by fostering development of new nonprofit banks Promote and support breastfeeding for mothers and infants
greater availability of safe banked donor milk for fragile infants.”).29 As a result, a rapidly increasing number of NICUs across the United States offer DHM as a supplement to mother’s own milk in order to make human milk a preferred alternative for the VLBW population.30,31 The Human Milk Banking Association of North America (HMBANA) is a nonprofit association that standardizes and facilitates the establishment and operation of DHM banks in North America.32,33 HMBANA defines a DHM bank as “a service established for the purpose of recruiting and collecting milk from donors and processing, screening, storing and distributing donated milk to meet the specific needs of individuals for whom human milk is prescribed by licensed health care providers.”33 Operational HMBANA DHM banks function under HMBANA’s guidelines for the establishment and operation of a donor milk bank.33 These guidelines, established by the HMBANA Guidelines Committee, represent a “mandatory minimum” for standards associated with all HMBANA DHM banks and “provide direction for donor milk banking in North America.”33 HMBANA membership requires sites to conduct annual self-assessments using a specific tool created by HMBANA and arranges a peer-reviewed assessment to be conducted by members from an alternate HMBANA DHM bank.33 Annual assessments are reviewed by the HMBANA Executive Board; noncompliance may result in suspension from HMBANA.33 Specific HMBANA goals are depicted in Table 1. Thirteen operational HMBANA milk banks dispensed more than 2 million ounces of DHM in 2011, a 17% increase from 2010 with the greatest increase in DHM use for VLBW infants.32 In 2010, the Food and Drug Administration recognized the need to collect and disseminate systematic, standardized DHM bank data and suggested that HMBANA develop a DHM registry.34 Of note, the HMBANA leadership described their role as “act[ing] as a liaison between member institutions and governmental regulatory agencies” (Table 1, item 6).33,35 Each HMBANA milk bank in the network reports unspecified statistics to “designated HMBANA members” on a quarterly basis to be used for internal tracking purposes,33 but a centralized data repository does not yet exist. The purpose of this study was to provide baseline data by describing data points currently collected by HMBANA
DHM banks and evaluate both the feasibility and potential interest in participating in a centralized DHM data repository.
Methods The Connecticut Human Milk Research Center developed a research agenda to capitalize on the strength of the Connecticut Children’s Medical Center NICU lactation services program. This group of multidisciplinary researchers is housed in the Division of Neonatology and Department of Pediatrics at Connecticut Children’s Medical Center within the University of Connecticut School of Medicine. In September 2012, a single member of the Connecticut Human Milk Research Center contacted all operational HMBANA milk banks in North America by telephone and described the purpose of the research study and the type of data being collected (Figure 1). The interviewer asked to speak with the most qualified person at each DHM bank to respond to these questions and invited the identified person to participate in a qualitative phone interview. This semistructured interview was pilot-tested among the research team and with 1 DHM bank. The interviews assessed whether individual milk banks collected data on a core group of variables, DHM bank academic or hospital affiliations (if any), donor demographics (eg, maternal age, parity, race, residential zip code), and DHM bank operations (eg, rescreening donors after 6 months of continued donation, definition of preterm milk, access to a human milk analyzer to determine the macronutrient content of batched samples). Second, the interviews evaluated the feasibility of and potential interest in participating in a centralized DHM data repository (whether data are computerized and, if so, what program the data are entered into, frequency of data entry and role of personnel entering the data, potential site participation in a centralized data repository). Univariate statistics described data collected from individual milk banks. This is an exploratory, descriptive study; we recruited a convenience sample and did not conduct a sample size calculation. Because the unit of analysis was the HMBANA milk bank and not human subjects, the Connecticut Children’s Medical Center Institutional Review Board granted this research study exemption.
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Figure 1. North American Operational Human Milk Banking Association of North America-Affiliated Donor Human Milk Bank Sites at the Time of Data Collection.a
a
S eptember 2012; N = 13. The United States and Canada are included. No additional operational Human Milk Banking Association of North America sites opened since data collection occurred.32 Google provides maps that can be printed when providing the proper attribution (bottom row of the map).
Results Thirteen operational HMBANA sites existed at the time of the study (Figure 1). Of this group, 8 sites consented to participate in this research study. Three sites declined to participate, and we were unable to contact the 2 additional sites. Of those unable to be contacted, we telephoned the sites a minimum of 5 times until the Connecticut Human Milk Research Center submitted an application to the HMBANA Research Committee to seek broader buy in and develop a collaborative consortium with HMBANA and its affiliated DHM banks. Specifically, Phase I proposed the completion of the baseline survey of all HMBANA milk banks, and Phase II included development of a standardized data collection tool and recruitment of HMBANA DHM banks to participate in a centralized data repository. We anticipated re-contacting the remaining 5 sites after HMBANA Research Committee approval of our application in order to complete our baseline data collection. However, the HMBANA Research Committee declined the Connecticut Human Milk Research Center’s request to develop a collaborative research consortium. Therefore, we did not attempt to re-contact the 5 DHM banks that had not yet agreed to participate in the study.
Most of the sites had a medical director associated with an academic institution (with access to an Institutional Review Board) (Table 2). All respondents collected some donor demographics, but demographics such as race, parity, and gestational age of the index child at birth were not systematically collected. Furthermore, half reported having a human milk analyzer on-site to document macronutrient composition, and all recorded the quantity of milk provided by each donor. Of the sites that rescreened donors after 6 months of continued donation, a single site used a written survey and all conducted blood tests to rescreen donors. Of note, the definition of preterm milk varied between milk banks (≤ 32 to ≤ 40 weeks). Most sites had computerized data and reported entering data daily (Table 2). The specific computer program used to house the data differed between sites (ranging from Access to Excel to a different program; Table 2). Half of the sites indicated that they would consider participating in a centralized DHM data repository. Of those sites, 50% stated that their participation was contingent on HMBANA leadership approval. Both declining sites indicated that data collection presently overseen by HMBANA was adequate.
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Table 2. Summary of Data Collected from Individual Milk Banks (n = 8). n DHM bank affiliations Milk bank affiliated with a hospital Yes No Milk bank affiliated with an academic institution Yes No Medical director of the milk bank affiliated with a hospital Yes No Medical director of the milk bank affiliated with an academic institution Yes No Milk bank has access to an Institutional Review Board Yes No Don’t know Demographics collected from donors Age Yes No Race Yes No Parity Yes No Residential zip codea Yes No Gestational age of index child at birth Yes No Number of weeks/months postpartum Yes No Donor is bereaved mother Yes No Index child born preterm Yes No Index child born at term Yes No
6 2
3 5
% 75.0 25.0 37.5 62.5
7 1
12.5 87.5
7 1
87.5 12.5
6 1 1
75.0 12.5 12.5 100.0 0.0 25.0 75.0 50.0 50.0 100.0 0.0 75.0 25.0 100.0 0.0 100.0 0.0 100.0 0.0 100.0 0.0
8 0 2 6 4 4 7 0 6 2 8 0 8 0 8 0 8 0
(continued)
Table 2. (continued) n DHM bank operations Rescreen donors after ≥ 6 months donation Yes No Record quantity of milk shipped to each hospital Yes No Process cow’s milk protein-free separatelya Yes No Process fat-free milkb Yes No Determine nutritional composition of each batch of pasteurized milka Yes No Gestational age cutoff to define preterm milkc ≤ 36 weeks for 30 days ≤ 36 weeks for 28 days ≤ 33 weeks for 28 days ≤ 32 weeks for 28 days Unknown Record total number of ounces donated (per mother) Yes No DHM bank data Data computerized Yes No Program/platform for data entryc Access Excel Other Frequency of data entryc Daily Monthly Job title of data entry personnel Varies (multiple people)c Interested in participating in a DHM registry Yes Yes, only if HMBANA approves No Unsure
4 4
8 0 5 3 3 5
% 50.0 50.0 100.0 0.0 62.5 37.5 37.5 62.5
4 3
57.1 42.9
1 3 1 1 1
14.3 42.9 14.3 14.3 14.3
8 0
100.0 0.0 87.5 12.5 42.9 14.3 42.9 85.7 14.3 100.0 25.0 25.0 25.0 25.0
7 1 3 1 3 6 1 5 2 2 2 2
Abbreviations: DHM, donor human milk; HMBANA, Human Milk Banking Association of North America. a For use in babies with cow’s milk protein allergy. b For use in babies with chylothorax. c Observations < 8; corresponding percentage calculated based on the number of respondents.
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Discussion This study reports that, among responding HMBANA DHM banks, the definition, collection, and management of data regarding milk donors and milk bank operations are inconsistent. This study highlights a gap in collaborative research by the human milk banking industry that may deter implementation of donor milk programs by NICUs and hinder benchmarking, research, and quality improvement initiatives. Donor milk use in North American NICUs is expanding rapidly, increasing the importance of monitoring its infrastructure and reporting outcomes. Further progress in this important public health initiative should address existing gaps in current HMBANA DHM bank practices and establish a centralized data repository. Such a repository could yield generalizable information useful to a variety of stakeholders including government and health care agencies, hospitals, health care providers, HMBANA leadership, and the DHM banks themselves. As nonprofit organizations, DHM banks face challenges regarding human and financial resources, yet development of the following processes would be beneficial: (1) develop a pertinent, standardized data set including common data fields and definitions; (2) enter data into a common computer program/platform; (3) recruit milk banks to participate in a centralized data repository; (4) train individual milk banks to upload data into a centralized database; (5) collect data from participating milk banks; (6) disseminate these data to stakeholders; and (7) sustain these efforts over time. Ideally, such a centralized data repository would be a collaboration between HMBANA leadership and academic researchers, modeled after the Vermont Oxford Network (VON).36 The VON is a voluntary collaboration between NICUs worldwide. Standardized data regarding the care and outcomes of VLBW newborns are collected, summarized, and disseminated to participating NICUs and other stakeholders. This centralized VON VLBW data repository is widely used for benchmarking, research, and quality improvement. A centralized data repository of HMBANA DHM banks would offer opportunities for similar benefits and initiatives. Our research has several strengths worth highlighting. First, this research question has not been previously evaluated. In particular, there are important clinical implications of our finding that the gestational age used to define preterm milk among HMBANA DHM banks is not standardized. HMBANA DHM banks variously define preterm milk as breast milk expressed by mothers of infants ranging from 32 to 40 weeks gestation, but prematurity is designated as birth < 37 weeks gestation. However, the evidence suggests that preterm milk significantly differs in macronutrient composition from term milk.37 NICUs purchasing DHM from multiple HMBANA milk banks likely assume that term/preterm milk is standardly defined. Therefore, NICUs may be purchasing, feeding, and fortifying preterm breast milk with a preconceived and potentially inaccurate
assumption of macronutrient composition. In turn, these assumptions may affect clinical outcomes both during hospitalization and beyond. Second, HMBANA leadership does not disseminate aggregate data to interested stakeholders.34 The collection and dissemination of these data could alleviate concerns regarding DHM safety and efficacy. A more consistent and transparent system may help facilitate integration of DHM programs into standard NICU practice.29,38-40 By describing existing data collection practices at participating HMBANAaffiliated DHM banks and providing a baseline for future comparative measures, our results begin to address the gaps in the current evidence base. Last, these results may be useful as HMBANA standardizes data collection practices at operational milk banks and may provide a data collection blueprint to developing and mentoring milk banks (ie, those not yet operational). These findings are subject to several limitations. HMBANA leadership declined the Connecticut Human Milk Research Center’s invitation to pursue this research collaboratively. Without centralized endorsement of this project, our overall response rate of 61.5% may not be representative of all HMBANA milk banks, potentially reducing the generalizability of our findings. As no publicly available data exist, we were unable to evaluate differences between respondents and nonrespondents in order to clarify this issue. However, a 61.5% response rate is within acceptable limits for a “cold call” data collection methodology.41 Second, HMBANA milk banks are not research institutions, and knowledge varied among respondents regarding data collection efforts at their site. Because specific roles are not standardized at HMBANA milk banks, it was not possible to interview personnel in the same role at each milk bank. This may limit the reliability of our findings. However, if a respondent was unsure or unable to answer a question, we requested an alternate DHM bank contact for follow-up. There was no specific question that all participating DHM banks were unable to answer. As a result, data collection was not 100% complete, but incomplete items were missing at random. Third, individual milk banks’ decision to participate in a centralized data repository is likely a complex and collaborative decision; the respondent may not have the authority required to make this decision. Fourth, this study did not exhaust all research possibilities regarding direction for subsequent studies. In particular, collection of data regarding site-specific protocols for pooling and pasteurizing samples is warranted. Last, the lack of standardization observed in milk banking may not be unique to HMBANA; instead, these results may reflect the rapid development of the DHM industry responding to increased DHM demand.38
Conclusion As the demand for DHM increases, data collected from individual HMBANA milk banks should be standardized,
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collected prospectively, warehoused in a central repository, and disseminated to stakeholders. To undertake this important public health initiative and secure the expertise required to establish this large-scale registry, we recommend collaborative efforts between HMBANA DHM banks, HMBANA leadership, and academic researchers. Declaration of Conflicting Interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The authors received no financial support for the research, authorship, and/or publication of this article.
References 1. American Academy of Pediatrics. Breastfeeding and the use of human milk. Pediatrics. 2012;129(3):e827-e841. 2. Ip S, Chung M, Raman G, et al. Breastfeeding and maternal and infant health outcomes in developed countries. Evid Rep Technol Assess (Full Rep). 2007;153:1-186. 3. Schanler RJ, Hurst NM, Lau C. The use of human milk and breastfeeding in premature infants. Clin Perinatol. 1999;26(2):379-398. 4. Schanler RJ, Lau C, Hurst NM, Smith EO. Randomized trial of donor human milk versus preterm formula as substitutes for mothers' own milk in the feeding of extremely premature infants. Pediatrics. 2005;116(2):400-406. 5. Schanler RJ, Shulman RJ, Lau C. Feeding strategies for premature infants: beneficial outcomes of feeding fortified human milk versus preterm formula. Pediatrics. 1999;103(6 Pt 1): 1150-1157. 6. Meier P, Enstrom JL, Patel AL, Jegier BJ, Bruns NE. Improving the use of human milk during and after the NICU stay. Clin Perinatol. 2010;37(1):217-245. 7. Isaacs EB, Fischl BR, Quinn BT, Chong WK, Gadian DG, Lucas A. Impact of breast milk on IQ, brain size and white matter development. Pediatr Res. 2010;67(4): 357-362. 8. Hylander MA, Strobino DM, Dhanireddy R. Human milk feedings and infection among very low birth weight infants. Pediatrics. 1998;102(3):E38. 9. Hylander MA, Strobino DM, Pezzullo JC, Dhanireddy R. Association of human milk feedings with a reduction in retinopathy of prematurity among very low birthweight infants. J Perinatol. 2001;21(6):356-362. 10. Furman L, Taylor G, Minich N, Hack M. The effect of maternal milk on neonatal morbidity of very low-birth-weight infants. Arch Pediatr Adolesc Med. 2003;157(1):66-71. 11. Furman L, Wilson-Costello D, Friedman H, Taylor HG, Minich N, Hack M. The effect of neonatal maternal milk feeding on the neurodevelopmental outcome of very low birth weight infants. J Dev Behav Pediatr. 2004;25(4):247-253. 12. Vohr BR, Poindexter BB, Dusick AM, et al. Beneficial effects of breast milk in the neonatal intensive care unit on the developmental outcome of extremely low birth weight infants at 18 months of age. Pediatrics. 2006;118(1):e115-e123.
13. Vohr BR, Poindexter BB, Dusick AM, et al. Persistent beneficial effects of breast milk ingested in the neonatal intensive care unit on outcomes of extremely low birth weight infants at 30 months of age. Pediatrics. 2007;120(4): e953-e959. 14. Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006;117(4):1253-1261. 15. Dowling DA, Blatz MA, Graham G. Mothers' experi ences expressing breast milk for their preterm infants: does NICU design make a difference? Adv Neonatal Care. 2012;12(6):377-384. 16. Kramer MS, Kakuma R. The optimal duration of exclu sive breastfeeding: a systematic review. Adv Exp Med Biol. 2004;554:63-77. 17. Edwards TM, Spatz DL. Making the case for using donor human milk in vulnerable infants. Adv Neonatal Care. 2012;12(5):273-280. 18. Ewer AK, Yu VY. Gastric emptying in pre-term infants: the effect of breast milk fortifier. Acta Paediatr. 1996;85(9): 1112-1115. 19. Cavell B. Gastric emptying in infants fed human milk or infant formula. Acta Paediatr Scand. 1981;70(5):639-641. 20. Fewtrell MS, Williams JE, Singhal A, Murgatroyd PR, Fuller N, Lucas A. Early diet and peak bone mass: 20 year followup of a randomized trial of early diet in infants born preterm. Bone. 2009;45(1):142-149. 21. Singhal A, Cole TJ, Fewtrell M, Lucas A. Breastmilk feeding and lipoprotein profile in adolescents born preterm: follow-up of a prospective randomised study. Lancet. 2004;363(9421):1571-1578. 22. Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-567.e1. 23. Nyqvist KH, Haggkvist AP, Hansen MN, et al. Expansion of the ten steps to successful breastfeeding into neonatal intensive care: expert group recommendations for three guiding principles. J Hum Lact. 2012;28(3):289-296. 24. Nyqvist KH, Haggkvist AP, Hansen MN, et al. Expansion of the baby-friendly hospital initiative ten steps to successful breastfeeding into neonatal intensive care: expert group recommendations. J Hum Lact. 2013;29(3):300-309. 25. Smith MM, Durkin M, Hinton VJ, Bellinger D, Kuhn L. Initiation of breastfeeding among mothers of very low birth weight infants. Pediatrics. 2003;111(6 Pt 1):1337-1342. 26. Rossman B, Kratovil AL, Greene MM, Engstrom JL, Meier PP. “I have faith in my milk”: the meaning of milk for mothers of very low birth weight infants hospitalized in the neonatal intensive care unit. J Hum Lact. 2013;29(3):359-365. 27. Hurst N, Engebretson J, Mahoney JS. Providing mother's own milk in the context of the NICU: a paradoxical experience. J Hum Lact. 2013;29(3):366-373. 28. Neville MC, Morton J, Umemura S. Lactogenesis: the transition from pregnancy to lactation. Pediatr Clin North Am. 2001;48(1):35-52. 29. US Department of Health and Human Services. The Surgeon General’s Call to Action to Support Breastfeeding. Washington,
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Brownell et al DC: US Dept of Health and Human Services, Office of the Surgeon General; 2011. 30. Perrine CG, Scanlon KS. Prevalence of use of human milk in US advanced care neonatal units. Pediatrics. 2013;131(6):1066-1071. 31. Parker MG, Barrero-Castillero A, Corwin BK, Kavanagh PL, Belfort MB, Wang CJ. Pasteurized human donor milk use among US level 3 neonatal intensive care units. J Hum Lact. 2013;29(3):381-389. 32. Human Milk Banking Association of North America website. www.hmbana.org. Accessed June 25, 2012. 33. Human Milk Banking Association of North America. Guidelines for the Establishment and Operation of Donor Human Milk Banks. Fort Worth, TX: Human Milk Banking Association of North America; 2011. 34. US Food and Drug Administration. 2010 meeting materials, Pediatric Advisory Committee to the Food and Drug Administration. US Food and Drug Administration website. www. fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ PediatricAdvisoryCommittee/ucm201871.htm. Accessed January 8, 2013.
35. Kennaugh J, Lockhart-Borman L. The increasing importance of human milk banks. EJ Neonatol Res. 2011;1(3):119-125. 36. Vermont Oxford Network website. www.vtoxford.org. Accessed January 21, 2013. 37. Bauer J, Gerss J. Longitudinal analysis of macronutrients and minerals in human milk produced by mothers of preterm infants. Clin Nutr. 2011;30(2):215-220. 38. Perrin MT, Fogleman A, Allen JC. The nutritive and immunoprotective quality of human milk beyond 1 year postpartum: are lactation-duration-based donor exclusions justified? J Hum Lact. 2013;29(3):341-349. 39. Arnold LD. U.S. health policy and access to banked donor human milk. Breastfeed Med. 2008;3(4):221-229. 40. Landers S, Hartmann BT. Donor human milk banking and the emergence of milk sharing. Pediatr Clin North Am. 2013;60(1):247-260. 41. WorldAPP. Developing successful customer satisfaction surveys. WorldAPP Key Survey website. http://docs.worldapp. com/collateral/KS/Developing_Successful_Customers_ Satisfaction_Survey.pdf. Accessed January 3, 2013.
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research-article2013
JHLXXX10.1177/0890334413508237Journal of Human LactationBrownell et al
Original Research
Donor Human Milk Bank Data Collection in North America: An Assessment of Current Status and Future Needs
Journal of Human Lactation XX(X) 1–7 © The Author(s) 2013 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0890334413508237 jhl.sagepub.com
Elizabeth A. Brownell, MA, PhD1, Mary M. Lussier, RN, BSN, IBCLC1, Victor C. Herson, MD1, James I. Hagadorn, MD, MS1, and Kathleen A. Marinelli, MD, IBCLC, FABM, FAAP1 Abstract Background: The Human Milk Banking Association of North America (HMBANA) is a nonprofit association that standardizes and facilitates the establishment and operation of donor human milk (DHM) banks in North America. Each HMBANA milk bank in the network collects data on the DHM it receives and distributes, but a centralized data repository does not yet exist. In 2010, the Food and Drug Administration recognized the need to collect and disseminate systematic, standardized DHM bank data and suggested that HMBANA develop a DHM data repository. Objective: This study aimed to describe data currently collected by HMBANA DHM banks and evaluate feasibility and interest in participating in a centralized data repository. Methods: We conducted phone interviews with individuals in different HMBANA milk banks and summarized descriptive statistics. Results: Eight of 13 (61.5%) sites consented to participate. All respondents collected donor demographics, and half (50%; n = 4) rescreened donors after 6 months of continued donation. The definition of preterm milk varied between DHM banks (≤ 32 to ≤ 40 weeks). The specific computer program used to house the data also differed. Half (50%; n = 4) indicated that they would consider participation in a centralized repository. Conclusion: Without standardized data across all HMBANA sites, the creation of a centralized data repository is not yet feasible. Lack of standardization and transparency may deter implementation of donor milk programs in the neonatal intensive care unit setting and hinder benchmarking, research, and quality improvement initiatives. Keywords breastfeeding, human milk, Human Milk Banking Association of North America, milk bank, public health surveillance
Well Established Data regarding Human Milk Banking Association of North America (HMBANA) milk banks are not publicly available. The Food and Drug Administration recognized the need to develop a centralized registry to collect and disseminate standardized data; this registry does not exist.
Newly Expressed HMBANA-affiliated milk banks do not collect consistent data regarding milk donors and milk bank operations. Lack of standardization and transparency may deter implementation of donor milk programs in the neonatal intensive care unit setting and hinder benchmarking, research, and quality improvement initiatives.
Background The health benefits of human milk for the very low birth weight (VLBW) population (≤ 1500 grams) are well
documented.1-24 However, expressing milk for a baby in the neonatal intensive care unit (NICU) can be challenging.25-27 As a result, mothers of VLBW infants are less likely to initiate milk expression and more likely to discontinue milk expression earlier than mothers of term infants.25,28 The use of donor human milk (DHM) in the NICU setting has allowed VLBW infants to receive the benefits of human milk when their mothers are unable to provide either some or all of the milk they need.17,22 The Surgeon General’s 2010 Call to Action to Support Breastfeeding highlighted the importance of DHM (“Action #12. Identify and address obstacles to 1
The Connecticut Human Milk Research Center, Division of Neonatology, Connecticut Children’s Medical Center, Hartford, CT, USA Date submitted: June 3, 2013; Date accepted: September 17, 2013. Corresponding Author: Elizabeth A. Brownell, The Connecticut Human Milk Research Center, Division of Neonatology, Connecticut Children’s Medical Center, 282 Washington Street, Hartford, CT 06106, USA. Email: [email protected]
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Table 1. Human Milk Banking Association of North America Mission/Goals.33 1. 2. 3. 4. 5. 6. 7. 8.
Ensure quality control of donor human milk banking among member banks through adherence to these mandatory guidelines and periodic inspection of member banks Annually review guidelines for donor milk banking practices in North America Provide a forum for networking among experts in the field on issues relating to donor human milk banking Provide information on the benefits and appropriate uses of banked human milk Communicate among member donor milk banks to assure adequate supplies for all patients Act as a liaison between member institutions and governmental regulatory agencies Advocate for increased use of donor milk by fostering development of new nonprofit banks Promote and support breastfeeding for mothers and infants
greater availability of safe banked donor milk for fragile infants.”).29 As a result, a rapidly increasing number of NICUs across the United States offer DHM as a supplement to mother’s own milk in order to make human milk a preferred alternative for the VLBW population.30,31 The Human Milk Banking Association of North America (HMBANA) is a nonprofit association that standardizes and facilitates the establishment and operation of DHM banks in North America.32,33 HMBANA defines a DHM bank as “a service established for the purpose of recruiting and collecting milk from donors and processing, screening, storing and distributing donated milk to meet the specific needs of individuals for whom human milk is prescribed by licensed health care providers.”33 Operational HMBANA DHM banks function under HMBANA’s guidelines for the establishment and operation of a donor milk bank.33 These guidelines, established by the HMBANA Guidelines Committee, represent a “mandatory minimum” for standards associated with all HMBANA DHM banks and “provide direction for donor milk banking in North America.”33 HMBANA membership requires sites to conduct annual self-assessments using a specific tool created by HMBANA and arranges a peer-reviewed assessment to be conducted by members from an alternate HMBANA DHM bank.33 Annual assessments are reviewed by the HMBANA Executive Board; noncompliance may result in suspension from HMBANA.33 Specific HMBANA goals are depicted in Table 1. Thirteen operational HMBANA milk banks dispensed more than 2 million ounces of DHM in 2011, a 17% increase from 2010 with the greatest increase in DHM use for VLBW infants.32 In 2010, the Food and Drug Administration recognized the need to collect and disseminate systematic, standardized DHM bank data and suggested that HMBANA develop a DHM registry.34 Of note, the HMBANA leadership described their role as “act[ing] as a liaison between member institutions and governmental regulatory agencies” (Table 1, item 6).33,35 Each HMBANA milk bank in the network reports unspecified statistics to “designated HMBANA members” on a quarterly basis to be used for internal tracking purposes,33 but a centralized data repository does not yet exist. The purpose of this study was to provide baseline data by describing data points currently collected by HMBANA
DHM banks and evaluate both the feasibility and potential interest in participating in a centralized DHM data repository.
Methods The Connecticut Human Milk Research Center developed a research agenda to capitalize on the strength of the Connecticut Children’s Medical Center NICU lactation services program. This group of multidisciplinary researchers is housed in the Division of Neonatology and Department of Pediatrics at Connecticut Children’s Medical Center within the University of Connecticut School of Medicine. In September 2012, a single member of the Connecticut Human Milk Research Center contacted all operational HMBANA milk banks in North America by telephone and described the purpose of the research study and the type of data being collected (Figure 1). The interviewer asked to speak with the most qualified person at each DHM bank to respond to these questions and invited the identified person to participate in a qualitative phone interview. This semistructured interview was pilot-tested among the research team and with 1 DHM bank. The interviews assessed whether individual milk banks collected data on a core group of variables, DHM bank academic or hospital affiliations (if any), donor demographics (eg, maternal age, parity, race, residential zip code), and DHM bank operations (eg, rescreening donors after 6 months of continued donation, definition of preterm milk, access to a human milk analyzer to determine the macronutrient content of batched samples). Second, the interviews evaluated the feasibility of and potential interest in participating in a centralized DHM data repository (whether data are computerized and, if so, what program the data are entered into, frequency of data entry and role of personnel entering the data, potential site participation in a centralized data repository). Univariate statistics described data collected from individual milk banks. This is an exploratory, descriptive study; we recruited a convenience sample and did not conduct a sample size calculation. Because the unit of analysis was the HMBANA milk bank and not human subjects, the Connecticut Children’s Medical Center Institutional Review Board granted this research study exemption.
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Figure 1. North American Operational Human Milk Banking Association of North America-Affiliated Donor Human Milk Bank Sites at the Time of Data Collection.a
a
S eptember 2012; N = 13. The United States and Canada are included. No additional operational Human Milk Banking Association of North America sites opened since data collection occurred.32 Google provides maps that can be printed when providing the proper attribution (bottom row of the map).
Results Thirteen operational HMBANA sites existed at the time of the study (Figure 1). Of this group, 8 sites consented to participate in this research study. Three sites declined to participate, and we were unable to contact the 2 additional sites. Of those unable to be contacted, we telephoned the sites a minimum of 5 times until the Connecticut Human Milk Research Center submitted an application to the HMBANA Research Committee to seek broader buy in and develop a collaborative consortium with HMBANA and its affiliated DHM banks. Specifically, Phase I proposed the completion of the baseline survey of all HMBANA milk banks, and Phase II included development of a standardized data collection tool and recruitment of HMBANA DHM banks to participate in a centralized data repository. We anticipated re-contacting the remaining 5 sites after HMBANA Research Committee approval of our application in order to complete our baseline data collection. However, the HMBANA Research Committee declined the Connecticut Human Milk Research Center’s request to develop a collaborative research consortium. Therefore, we did not attempt to re-contact the 5 DHM banks that had not yet agreed to participate in the study.
Most of the sites had a medical director associated with an academic institution (with access to an Institutional Review Board) (Table 2). All respondents collected some donor demographics, but demographics such as race, parity, and gestational age of the index child at birth were not systematically collected. Furthermore, half reported having a human milk analyzer on-site to document macronutrient composition, and all recorded the quantity of milk provided by each donor. Of the sites that rescreened donors after 6 months of continued donation, a single site used a written survey and all conducted blood tests to rescreen donors. Of note, the definition of preterm milk varied between milk banks (≤ 32 to ≤ 40 weeks). Most sites had computerized data and reported entering data daily (Table 2). The specific computer program used to house the data differed between sites (ranging from Access to Excel to a different program; Table 2). Half of the sites indicated that they would consider participating in a centralized DHM data repository. Of those sites, 50% stated that their participation was contingent on HMBANA leadership approval. Both declining sites indicated that data collection presently overseen by HMBANA was adequate.
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Table 2. Summary of Data Collected from Individual Milk Banks (n = 8). n DHM bank affiliations Milk bank affiliated with a hospital Yes No Milk bank affiliated with an academic institution Yes No Medical director of the milk bank affiliated with a hospital Yes No Medical director of the milk bank affiliated with an academic institution Yes No Milk bank has access to an Institutional Review Board Yes No Don’t know Demographics collected from donors Age Yes No Race Yes No Parity Yes No Residential zip codea Yes No Gestational age of index child at birth Yes No Number of weeks/months postpartum Yes No Donor is bereaved mother Yes No Index child born preterm Yes No Index child born at term Yes No
6 2
3 5
% 75.0 25.0 37.5 62.5
7 1
12.5 87.5
7 1
87.5 12.5
6 1 1
75.0 12.5 12.5 100.0 0.0 25.0 75.0 50.0 50.0 100.0 0.0 75.0 25.0 100.0 0.0 100.0 0.0 100.0 0.0 100.0 0.0
8 0 2 6 4 4 7 0 6 2 8 0 8 0 8 0 8 0
(continued)
Table 2. (continued) n DHM bank operations Rescreen donors after ≥ 6 months donation Yes No Record quantity of milk shipped to each hospital Yes No Process cow’s milk protein-free separatelya Yes No Process fat-free milkb Yes No Determine nutritional composition of each batch of pasteurized milka Yes No Gestational age cutoff to define preterm milkc ≤ 36 weeks for 30 days ≤ 36 weeks for 28 days ≤ 33 weeks for 28 days ≤ 32 weeks for 28 days Unknown Record total number of ounces donated (per mother) Yes No DHM bank data Data computerized Yes No Program/platform for data entryc Access Excel Other Frequency of data entryc Daily Monthly Job title of data entry personnel Varies (multiple people)c Interested in participating in a DHM registry Yes Yes, only if HMBANA approves No Unsure
4 4
8 0 5 3 3 5
% 50.0 50.0 100.0 0.0 62.5 37.5 37.5 62.5
4 3
57.1 42.9
1 3 1 1 1
14.3 42.9 14.3 14.3 14.3
8 0
100.0 0.0 87.5 12.5 42.9 14.3 42.9 85.7 14.3 100.0 25.0 25.0 25.0 25.0
7 1 3 1 3 6 1 5 2 2 2 2
Abbreviations: DHM, donor human milk; HMBANA, Human Milk Banking Association of North America. a For use in babies with cow’s milk protein allergy. b For use in babies with chylothorax. c Observations < 8; corresponding percentage calculated based on the number of respondents.
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Discussion This study reports that, among responding HMBANA DHM banks, the definition, collection, and management of data regarding milk donors and milk bank operations are inconsistent. This study highlights a gap in collaborative research by the human milk banking industry that may deter implementation of donor milk programs by NICUs and hinder benchmarking, research, and quality improvement initiatives. Donor milk use in North American NICUs is expanding rapidly, increasing the importance of monitoring its infrastructure and reporting outcomes. Further progress in this important public health initiative should address existing gaps in current HMBANA DHM bank practices and establish a centralized data repository. Such a repository could yield generalizable information useful to a variety of stakeholders including government and health care agencies, hospitals, health care providers, HMBANA leadership, and the DHM banks themselves. As nonprofit organizations, DHM banks face challenges regarding human and financial resources, yet development of the following processes would be beneficial: (1) develop a pertinent, standardized data set including common data fields and definitions; (2) enter data into a common computer program/platform; (3) recruit milk banks to participate in a centralized data repository; (4) train individual milk banks to upload data into a centralized database; (5) collect data from participating milk banks; (6) disseminate these data to stakeholders; and (7) sustain these efforts over time. Ideally, such a centralized data repository would be a collaboration between HMBANA leadership and academic researchers, modeled after the Vermont Oxford Network (VON).36 The VON is a voluntary collaboration between NICUs worldwide. Standardized data regarding the care and outcomes of VLBW newborns are collected, summarized, and disseminated to participating NICUs and other stakeholders. This centralized VON VLBW data repository is widely used for benchmarking, research, and quality improvement. A centralized data repository of HMBANA DHM banks would offer opportunities for similar benefits and initiatives. Our research has several strengths worth highlighting. First, this research question has not been previously evaluated. In particular, there are important clinical implications of our finding that the gestational age used to define preterm milk among HMBANA DHM banks is not standardized. HMBANA DHM banks variously define preterm milk as breast milk expressed by mothers of infants ranging from 32 to 40 weeks gestation, but prematurity is designated as birth < 37 weeks gestation. However, the evidence suggests that preterm milk significantly differs in macronutrient composition from term milk.37 NICUs purchasing DHM from multiple HMBANA milk banks likely assume that term/preterm milk is standardly defined. Therefore, NICUs may be purchasing, feeding, and fortifying preterm breast milk with a preconceived and potentially inaccurate
assumption of macronutrient composition. In turn, these assumptions may affect clinical outcomes both during hospitalization and beyond. Second, HMBANA leadership does not disseminate aggregate data to interested stakeholders.34 The collection and dissemination of these data could alleviate concerns regarding DHM safety and efficacy. A more consistent and transparent system may help facilitate integration of DHM programs into standard NICU practice.29,38-40 By describing existing data collection practices at participating HMBANAaffiliated DHM banks and providing a baseline for future comparative measures, our results begin to address the gaps in the current evidence base. Last, these results may be useful as HMBANA standardizes data collection practices at operational milk banks and may provide a data collection blueprint to developing and mentoring milk banks (ie, those not yet operational). These findings are subject to several limitations. HMBANA leadership declined the Connecticut Human Milk Research Center’s invitation to pursue this research collaboratively. Without centralized endorsement of this project, our overall response rate of 61.5% may not be representative of all HMBANA milk banks, potentially reducing the generalizability of our findings. As no publicly available data exist, we were unable to evaluate differences between respondents and nonrespondents in order to clarify this issue. However, a 61.5% response rate is within acceptable limits for a “cold call” data collection methodology.41 Second, HMBANA milk banks are not research institutions, and knowledge varied among respondents regarding data collection efforts at their site. Because specific roles are not standardized at HMBANA milk banks, it was not possible to interview personnel in the same role at each milk bank. This may limit the reliability of our findings. However, if a respondent was unsure or unable to answer a question, we requested an alternate DHM bank contact for follow-up. There was no specific question that all participating DHM banks were unable to answer. As a result, data collection was not 100% complete, but incomplete items were missing at random. Third, individual milk banks’ decision to participate in a centralized data repository is likely a complex and collaborative decision; the respondent may not have the authority required to make this decision. Fourth, this study did not exhaust all research possibilities regarding direction for subsequent studies. In particular, collection of data regarding site-specific protocols for pooling and pasteurizing samples is warranted. Last, the lack of standardization observed in milk banking may not be unique to HMBANA; instead, these results may reflect the rapid development of the DHM industry responding to increased DHM demand.38
Conclusion As the demand for DHM increases, data collected from individual HMBANA milk banks should be standardized,
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collected prospectively, warehoused in a central repository, and disseminated to stakeholders. To undertake this important public health initiative and secure the expertise required to establish this large-scale registry, we recommend collaborative efforts between HMBANA DHM banks, HMBANA leadership, and academic researchers. Declaration of Conflicting Interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The authors received no financial support for the research, authorship, and/or publication of this article.
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