Factors Inuencing Breast Milk Donation To a Human Milk Bank in Iran: Implications for Policymakers and Planners

World Health Organization actively promotes breastfeeding as the best nourishment source for infants and young children. However, access to human milk for all newborns is not always possible, leading to nutritional benets deprivation or nancial burden related to acquiring alternatives. Establishing human milk banks (HMB) could facilitate equitable access to donated human milk. However, various factors may impede human milk donation. This study identies factors inuencing milk donation to HMB in Iran. Methods We conducted a case-control study among mothers who had given birth at least one year before the study, with 51 cases (mothers who donated their milk to HMB) and 153 controls. Data were collected by a questionnaire designed to obtain retrospective information about individual health, social network, and other factors. Logistic regressions were used to examine relationships between breast milk donation and these factors. Qualitative data were collected during face-to-face interviews and analysed using a content analysis approach to elicit viewpoints of HMB senior staff and mothers on the factors inuencing milk donation. Family factors, social factors, individual social welfare score, and breast milk adequacy were associated with increased milk donation. Family support for human milk donation was among the strongest predictors.


Introduction
Breastfeeding, also known as nursing, provides health bene ts for both mother and infant and its importance in low-income and middle-income countries is well recognised [1]. Mother's milk is the best nutrition for term and preterm infants. It provides vital nutritional and immunological advantages for mother and infant and brings economic bene ts for the family [1][2][3]. Studies have shown that human milk positively affects preterm infants' cognitive function [4][5][6]. The United Nations International Children's Emergency Fund and World Health Organization (WHO) emphasise the fundamental role of breastfeeding in addressing reaching the Sustainable Development Goals (SDGs), including improving child nutrition (SDG 2), preventing child mortality and decreasing the risk of non-communicable diseases (SDG 3), and supporting cognitive development and quality education (SDG 4) [7].
Despite the crucial role of breastfeeding in infant health and development, unfortunately, not all infants have access to breastfeeding or their own mother's milk due to various reasons (i.e., health-related problems, maternal death, separation). Following WHO, donated breast milk is one of the best preferred choices for infants with no access to their mothers' breast milk [8]. Although the donated breast milk has lesser nutritional value than the biological mother's milk, it is more bene cial than the powdered alternative, particularly for premature or high-risk neonates [9][10][11]. However, premature infants' direct donor milk consumption is not always possible due to bacteriological and viral contamination [12]. Human milk banks (HMBs) may play a critical role in response to these challenges by recruiting breast milk donors and collecting, processing, screening, storing, and distributing safe donated human milk [13].
Nowadays, HMBs operate worldwide for over a century and increase human donor milk availability within a clear equity framework [14]. Over 600 HMBs had been established in more than 60 countries, although most are in Europe, the USA, Asia, and Brazil [7].
In Iran, human milk donation is one of the oldest traditions. Nonetheless, it is not widespread, primarily due to cultural aspects and religious beliefs. For example, the potential donor mother should be very well acquainted with an infant's family in need of human milk. Also, the donor mother will be treated and perceived almost on par with the infant's mother -something that the biological mothers do not always favour or accept. Moreover, the donor's children would be treated as brothers and sisters of the breast milk recipient and cannot marry the milk recipient in the future [15]. Such cultural aspects and beliefs, together with the proven bene ts of donated breast milk in the absence of a comprehensive and formal way to donate human milk in Iran, persuaded the top health managers of the country to establish the rst AL Zahra HMB a liated to Tabriz University of Medical Sciences, Tabriz, Iran in 2016. The idea to open the HMB was developed after several health managers from the Ministry of Health and Medical Education visited an HMB earlier in the Netherlands. By 2021, ten more HMBs were established in Iran. Now, Iran ranks rst in the Middle East with the highest number of HMS.
Our previous study has shown that countries with established HBMs need continuous development and adjustment of strategies to attract milk donors and maintain the functioning of HBMs. These strategies must account for various individual and social systemic barriers and facilitators to human milk donation.
Moreover, they also should be country context-speci c [11]. Mothers' participation in breast milk donation and uptake are the cornerstones of ensuring the effective work of any HMB. However, it can become obsolete in the absence of appropriate training and addressing mother-speci c barriers to participation in the milk donation program [16]. Despite the growing number of HMBs in Iran, to the best of our knowledge, no previous study has examined factors that can act as barriers and (or) facilitators of breast milk donation to HMBs. We address this evidence gap by looking at factors and determinants that affect human milk donation in Iran's longest functioning AL Zahra HMB.

Design
We conducted a mixed-method study, using both quantitative and qualitative elements during data collection and analyses. Purposeful data integration enabled us to seek a more panoramic view of the research landscape, viewing phenomena (donation to milk bank) from different viewpoints and diverse research lenses. The results of the quantitative and qualitative studies were combined during the interpretation stage in this study.

Quantitative part
We used a case-control design and recruited eligible participants among mothers admitted to AL Zahra Hospital between April and October 2016. The case was de ned as a mother who visited the hospital to receive needed health services after delivery and participated in a donor milk program in the hospital, based on hospital records. A control was de ned as a mother who attended the hospital for routine health services but did have a prior history of milk donation. Participants in both groups had given birth at least one year before the study. We recruited 200 participants with a 1:3 case-control ratio. The participants were recruited using convenience sampling from mothers who visited the hospital or milk bank (part of the hospital). The data were collected using a questionnaire during face-to-face structured interviews.

Data collection tool
Cases and controls were asked to ll out a questionnaire in Persian with precoded questions designed to collect retrospective information on participant's health and socio-economic status, social network, beliefs and cultural characteristics of participants and their closest family members and friends. The questionnaire's content was informed by a comprehensive literature review complemented by interviews with healthcare experts (n=17) from different healthcare sector levels (i.e., health services management, epidemiology, nursing and paediatrician). Questions examined factors related to human milk donation on individual, family and friends, health system, community, and social welfare level. Personal questions focused on the mother's perceived quality of milk, repeated breastfeeding, and the painfulness of breasts at the time of breastfeeding, perception of milk donation's physical and mental effects. Family and friends questions were about the participant's mother, husband, family-in-law, and closest friends attitude towards milk donation. Health system questions were about the milk bank's availability, health volunteers' training, educational materials about milk donation, and access to the milking machine (pump). Other questions focused on the culture of human milk donation as a form of helping others, belief in the creation of incest and milk-siblings with milk donations, the belief in the usefulness of milk donation, and the media's role in informing mothers regarding milk donation.
The questionnaire content validity was reviewed and approved by ten experts and health professionals using content validity ratio (CVR) and content validity index (CVI). CVR showed the necessity of questions, and CVI determined the simplicity, relevance, and clarity of questions. Resulting CVR and CVI were 93% and 92%, respectively. To check test-retest reliability, tests were conducted twice, with an interval of two weeks between tests. Test-retest data from 20 potential participants were collected. Inter-class correlation (ICC) coe cients at a 95% con dence interval were computed for each selected item. Overall, ICC was calculated at 0.98, and Cronbach's alpha was 0.76, which showed good reliability.

Qualitative part
Semi-structured interviews were conducted face-to-face with breastfeeding mothers as cases (n=14) and HMB experts (n=7) in East Azerbaijan Province, Iran. Breastmilk donors were selected through convenience sampling, and HMB staff were chosen by the purposive sampling method. The criteria for selecting HMB experts were working experience in HMB or having any role in establishing HMB, or being planners or policymakers in this eld. Researchers who would perform the semi-structured interviews familiarised themselves for at least two months with the research facility, including the HMB and the hospital's newborn intensive care unit. All interviews were digitally recorded and then transcribed verbatim. Interviews were conducted until the data saturation was reached. Following the interview, participants reviewed and con rmed the interview's content.

Data analysis
Continuous variables were expressed as means and 95% con dence intervals (95% CI), and percentages were calculated for categorical variables. Comparison of continuous and categorical variables in both control and case groups was made using Student's t-test and chi-squared test, respectively, and any statistically signi cant difference was noted. Fisher's exact test was used as appropriate. Odds Ratio (OR) and 95% CIs associated with each potential factor involved in milk donation were calculated using bivariate logistic regression models. For the study, P < 0.05 was considered statistically signi cant. All analyses were performed using SPSS 23 (IBM Corp., Armonk, N.Y., USA).
Qualitative data were analysed using the content analysis approach. After transcription, the interview manuscript was studied several times to extract main and general concepts. By reviewing word by word and specifying semantic units, the initial codes were extracted. Data were reduced by removing duplicate codes. Codes with similar concepts were placed in a more general category, and, eventually, central themes were formed. Themes extracted from the interview's manuscript were con rmed by an external reviewer familiar with the qualitative study methodology.
Results 204 participants (51 cases and 153 controls) were included in the study after lling out a questionnaire. Cases and controls were on average 30 years old (30.12 ± 4.88 and 30 ± 4.84; respectively), had at least 1-2 pregnancies, most were housewives (cases: n = 48, 91.3%; controls: n = 129; 84.4%), and had a diploma or bachelor/higher educational attainment (cases: n = 37, 72.5%; controls: n = 137; 89.5%). The proportion of those having more than one child in the case group was 47.1% (n = 24) and in the control group was 61.4% (n = 94) (P = 0.162). 17.5% (n = 14) of mothers with a history of milk donation and 10.5% (n = 16) of mothers without a history of milk donation were employed out of home (P < 0.01). Other participants characteristics can be found in Table 1. The factors in uencing mink donation to HMBs fell into four main categorical themes )physiological factors, societal attitudes and beliefs, training and motivators and accessibility( and 14 subthemes (Table 2).  Concerning perceptions regarding human milk donation, compared to the control mothers, cases stated that they still have milk after breastfeeding more often and agreed that frequent milk expression increases the quantity of their breast milk (both P < 0.001) ( Table 3). Compared to controls, cases also believed that donating milk is more physically and mentally bene cial and stated that other babies could use the donated milk (P < 0.001). According to the participants, physiological factors in uenced breastfeeding, and the amount of breast milk was the most crucial factor. "A mother who has enough milk herself and produces more milk than her baby needs and has no di culty in breastfeeding has more motivation for milk donation." (Mother 3) The attitude of family and friends towards human milk donation also differed between cases and controls (Table 4). Overall, cases reported stronger support for milk donation from their spouses and family than controls (both P < 0.001). Interestingly, for both cases and controls, the encouragement from friends to donate milk to an HMB was low, particularly for controls (P < 0.001). According to the participants, family and husband's attitudes and beliefs towards breastfeeding impacted breastmilk donation decisions. "Even though I have much milk, my mother-in-law is against donating breastmilk, and her attitude affects my husband; that is why he is also against donating milk." (Mother 8) The importance of about half of the health care system factors related to human milk donation differed between cases and controls (Table 5). Overall, compared to controls, cases had a greater possibility to go to an HMB, were more often offered a non-nancial incentive by health workers to donate milk, agreed that milk donation was made more accessible to them by offering a milking machine (pump), and seen an advertisement about human milk donation (all P < 0.001). Despite these differences, most controls and cases stated that they were taught about milk donation during childbirth at the hospital. The majority stated that they were not taught about milk donation by a community health worker, a paediatrician, or a midwife during pregnancy. Long-distance commute, lack of a milk bank and easy access to a milk bank in cities, lack of a way to collect donated milk quickly and easily in the township were among some of the milk donation barriers. "There is only one milk bank, and it is situated in the centre of the province. If the donor is in the township, she must go to the centre of the province by using a vehicle, which is why so many mothers prefer not to donate their milk." (Mother 7) meetings, and the distribution of informative posters. "Generally, our donors are those who are in the neonatal and newborn intensive care unit section, and they are dealing with the process of donating milk. Therefore, they understand the need for donated milk and the internal advertising is done by in uential people such as the head nurse." (Senior Staff) "When mothers are trained how can they donate their milk, it encourages them to donate." (Junior Staff) Most cultural and social factors related to human milk donation differed between cases and control (Table 6). For instance, mothers in the cases group more frequently than controls believed that milk donation does not build a family relation between the donor and a recipient, milk donation is helping others, and it will bring God's reward. Compared to controls, cases also reported having heard about human milk donation via mass media. Participants believed that culture, society, religious and spiritual beliefs are among signi cant factors that in uence human milk bank donation. Divine reward, altruism and humanity, helping others, making other parents happy were factors that can affect the donation of human milk. "I vowed that if my baby were born healthy, my baby would eat half of my milk, and I will give the other half to other babies." (Mother 4) Many participants pointed out that religious beliefs such as consanguinity and kinship are among the critical barriers to milk donation. "I believe that if a mother breastfeeds a child, that a child will become consanguineous with her children, and they should not marry each other in the future." (Mother 12) Based on the bivariate regression analysis results, the mother's breast milk su ciency was signi cantly higher in cases than the controls (P 0.001 for all). Also, there are no statistically signi cant differences in women's characteristics between cases and controls. Individual, family, social and health system factors were positively and signi cantly associated with milk donation (P 0.001 for all). Overall, the ndings of qualitative and qualitative parts were in line with each other. Our quantitative and qualitative ndings showed that societal attitudes and beliefs, training, motivation, and accessibility were among the most in uential factors for mothers' milk donation to HMB. Even though the quantitative ndings did not show a signi cant relationship between physiological factors and milk donation to HMB, the physiological factors were important for milk donation to HMB, based on the mother's perspectives.

Discussion
HMBs require donor milk and, therefore, cannot exist in the absence of a well-established and vibrant breastfeeding culture [16]. Our ndings con rmed that family and community support of breastfeeding mothers and counselling are crucial to promoting human milk donation to HMBs. Therefore, the government should establish and implement programs that provide welfare facilities to ensure mothers receive support for human milk donation to HMBs.
We found that perceptions by family and friends regarding human milk donation are among the most critical factors that could in uence mothers' decision to donate breast milk. Husbands' disagreement with milk donation can signi cantly decrease human milk donations to the HMB. According to the previous studies, this challenge can be resolved by conducting training for fathers and increasing awareness of the HMB activities, aims, and positive effects of milk donation on mothers and children [17][18][19]. Having a su cient amount of milk is another in uential individual factor for human milk donation. Mothers that had enough milk after feeding their child were more interested in donating their milk to HMB. For example, Azema (2003) showed that in 40-60% of mothers, the main reasons for donating their milk were having more milk and an individual's desire to help others in need (i.e., altruism) [20]. The ndings of the Gribble study (2014) on 97 women donors also showed that having more milk and preventing milk waste were among the reasons for human milk donation to HMB [21].
The health system providers such as physicians, nurses, and health workers have the leading role in training and motivating mothers to donate their milk [22]. Evidence implies that developing training programs for parents and their relatives by a physician or a nurse would build trust in parents and positively affect human milk donation to HMB [10,23]. Mackenzie et al. (2013) showed that healthcare staff and healthcare professionals are an essential source of information for milk donors [24]. Pimenteira et al. (2008) also showed that the creation of multiple stimulants by a health professional could be a factor in human milk donating. More speci cally, at the time of hospitalisation for childbirth, the mother should be provided with information about the importance of human milk donation and be informed about the need for other infants, deprived of their mother's milk, for donated human milk [25].
Our study con rmed a signi cant relationship between physicians and milk donation; however, training by other health workers had no statistically signi cant relationship with human milk donation to HMB. Perhaps, this can be explained by the fact that the HMBs in Iran are relatively new and are not fully integrated into the healthcare system. Another reason could be that health care providers and health volunteers do not yet have su cient information about HMBs or the importance of milk donation to the HMB. We also observed no signi cant relationship between training during childbirth and milk donation.
However, there was a signi cant relationship between human milk donation and advertising in hospital wards, such as neonatal intensive care unit and health centres with human milk donation. The mother's condition after pregnancy or childbirth and poor quality of training in hospitals can be yet another reason for the lack of a statistically signi cant relationship between training programs and human milk donation to HMB. Hence, using evidence-based and updated training could be in uential on milk donation to HMB. The establishment of an HMB in predominantly Muslim countries could be challenging due to some religious concerns. Some families would even refuse to receive donated human milk [27][28][29]. In the study by Grol et al. (2014), 36.3% stated that mother's milk banking constituted a problem due to religious aspects, and 28.9% said it could lead to social and moral problems [30]. Although in many Muslim countries, belief in privacy by donating milk is one of the barriers to milk donation, Iran does not seem to face such a problem. With the correct information, this obstacle can be eradicated. The lack of information about breastfeeding given to mothers is evident. Carroll et al. (2014) showed that pregnant mothers training and health professionals' support of milk donors, especially the support of donors who have lost their children, are in uential on milk donation to HMB. Using facilities for increasing mother's access to milk banks could also promote their motivation for milk donation to HMBs [26].

Conclusion
One of the central policies of the Iran healthcare system that could motivate mothers to donate milk to HMB are training programs. Developing evidence-based, updated training programs is essential to decreasing households barriers to milk donation to HMBs. Training should include all members of society, including breastfeeding mothers, their spouses, family members, and closest friends if necessary.
Information campaign strategy should involve various mass media sources, health system sector professionals, and social and religious organisations. Maternal education during pregnancy is a central, in uential, and crucial factor in preparing mothers for milk donation in the future. Before starting the interview, the interviewees were fully explained about the importance, aims and research methods. The written consent form was obtained from the participants. The ethics committee of Tabriz University of Medical Sciences approved the project (Approval No: IR.TBZMED.REC.1396. 19). All methods were carried out in accordance with relevant guidelines and regulations.

Consent for publication
Not applicable.

Availability of data and materials
Due to the con dentiality and anonymity of participants and the data being drawn from the qualitative study, the interview data cannot be freely shared.

Competing interest
Authors declare that they have no competing interests.

Funding
The authors have not received any nancial grant from any organisation or funding agency.
Authors' contributions LD conceived the study, participated in data collection development tool and data analysis and interpretation, as well as preparation of the manuscript. AA contributed to the development of the data collection tool, carried out some parts of data analysis, and contributed to the drafting of the manuscript. KG carried out data analysis and data interpretation and contributed to the writing of the manuscript.
VSG participated in writing and several editings of the manuscript, data analyses and interpretation. All authors read and approved the nal manuscript.