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Promoting the use of pasteurized human donor milk in the NICU

Baumgartel, Kelley PhD, RN; Deem, Michael J. PhD

doi: 10.1097/01.NURSE.0000604728.66073.f7

Using pasteurized human donor milk in the NICU

Kelley Baumgartel is an assistant professor at the Duquesne University School of Nursing in Pittsburgh, Pa., and Michael J. Deem is an assistant professor in the School of Nursing and Center for Healthcare Ethics at Duquesne University.

The authors have disclosed no financial relationships related to this article.

SEVERAL MAJOR health organizations and professional healthcare associations recommend that critically ill preterm infants receive pasteurized human donor milk (PHDM) when the maternal milk supply does not meet the infant's daily milk volume requirements.1-3 Those who receive PHDM experience fewer central venous catheter insertions, decreased ventilatory support, shorter hospital stays, and a significantly reduced risk of necrotizing enterocolitis and bronchopulmonary dysplasia compared with infants who receive bovine-milk-based formula.4 Additionally, infants who receive PHDM have a lower incidence of both retinopathy of prematurity and sepsis.5 Immune components present in human milk, including immunoglobulins, cytokines, and antimicrobial proteins, likely contribute to these benefits.6

Despite the evidence supporting the use of PHDM for critically ill neonates, parents sometimes refuse PHDM and prefer formula for their infant.7 Given the evidence that the provision of formula in the neonatal ICU (NICU) is suboptimal compared with provision of PHDM for critically ill and preterm infants, this article discusses whether clinicians should challenge parental refusal of PHDM. The issue of access for preterm infants born at hospitals that do not use PHDM is also discussed.

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Parents as decision-makers

Clinicians generally defer to parents when it comes to decisions about pediatric care. This deference seems appropriate because parents are generally better able to identify and promote their child's preferences and desires, and they can also anticipate how healthcare decisions might affect family dynamics.8,9 However, decision-making involving neonates is often more complicated because neonates are not yet capable of forming specific preferences that their parents can identify and promote.10 In the NICU, many decisions must be based primarily on evidence-based clinical judgments about the benefits, risks, and outcomes of available treatment options.

In such cases, it may be ethically appropriate for clinicians to question or even override parents' decisions for an infant's care. For example, clinicians should challenge parental refusal of treatment that would likely benefit the infant significantly, as well as parental requests for a treatment that would likely lead to significant harm. It is less clear, however, in which circumstances clinicians may appropriately challenge parental preferences for treatments that are merely suboptimal or carry incremental risk compared with those that they regard as standard of care. Such situations require careful ethical deliberation about the duties clinicians have to defer to reasonable parental decisions about care while also advocating for the health of the neonate.

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Advocating for the neonate

Given that the provision of formula in the NICU is suboptimal in comparison to the provision of PHDM for critically ill infants, should clinicians challenge parental refusal of PHDM? Froh and Spatz provide an important ethical perspective on this question that is grounded in their research and nursing experience in a major pediatric hospital.11 They argue that feeding decisions in the NICU should be based solely on the best interest of the neonate. Given the significant benefits of human milk for neonates and the health risks associated with not consuming breast milk early in life, Froh and Spatz conclude that clinicians have an ethical obligation to provide only the former to these neonates.11 In cases where maternal milk supply is insufficient, PHDM should be provided. Parental preference, they further assert, should not factor in this decision.

This argument has some plausibility. Leaving decisions about NICU feeding entirely to parental discretion is unreasonable because it ignores the benefits and improved outcomes from using PHDM for critically ill infants and fails to take seriously the risks associated with use of formula in the NICU. However, when parents refuse PHDM, it is not the same as refusing life-sustaining treatment or requesting treatments that are likely to produce significant harm. Thus, determining whether PHDM should always be provided is not as simple as reasoning that the superior benefits of PHDM create an obligation to provide only PHDM regardless of parenteral preferences. One must also consider any risks that PHDM carries for neonates, including a small risk of transmitting bacteria or viruses. Other considerations should include the potential impact overriding parental preferences has on care, and questions of justice and access to it.

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Weighing potential drawbacks to PHDM

Preterm infants fed PHDM tend to experience slower growth compared with preterm infants who receive formula.4,12 While compromised growth is associated with poorer long-term neurodevelopmental outcomes, a recent systematic review did not find direct evidence that PHDM is associated with long-term health or neurodevelopment deficits.13

Some viruses and bacteria can be transmitted via human milk, including HIV, hepatitis B and C viruses, and human T-lymphotropic virus types I and II.14 Traces of medications and drugs can also be present in human milk at the time of procurement. (See How is donor milk obtained and stored?) Given the strict donor vetting and milk pasteurization processes, the risk of contamination is small but not nonexistent, even when milk banks and hospitals adhere closely to safety guidelines.1 Nonetheless, the benefit-risk analysis favors the utilization of PHDM rather than formula for a critically ill preterm infant.

However, this does not mean that we should also conclude that parental preferences for formula should not factor into feeding decisions. This additional conclusion would depend on abstracting from real clinical conditions and considering only what we ought hypothetically to do for a single critically ill or preterm infant. When we are attentive to the nonideal conditions of actual clinical practice and the realities of access to clinical resources, we see additional ethical factors to consider.

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Access and shared decisions

Resource-rich hospitals have higher usage rates of PHDM than “safety net” hospitals where roughly 75% of patients use Medicaid.15 Only a handful of states, including Pennsylvania, New York, and Texas, have approved Medicaid reimbursement for PHDM. As a consequence, PHDM might be cost-prohibitive for resource-limited hospitals or families from underserved communities and regions. The potential cost burdens of PHDM for some families is a consideration that should not be ignored when making NICU feeding decisions.

Limited supply and high demand also compromise access to PHDM.1 While part of this limited supply is due to low donation rates and safe milk-banking processes, nonusage rates in NICUs might be as high as 40%.16 Clinicians, therefore, likely could not satisfy a putative ethical obligation to provide PHDM to all critically ill preterm neonates given these practical considerations. The scarcity of PHDM, compounded by nonuse in some NICUs, generates an ethical duty to be reasonable stewards of this resource. Due to scarcity of PHDM, clinicians sometimes have to make difficult allocation decisions and exclude some eligible infants. Prioritizing the sickest neonates and respecting some instances of parental refusal are ways clinicians might satisfy their duty to be reasonable stewards of available resources.

Moreover, high-resource institutions that aim to satisfy a perceived obligation to give PHDM to all eligible neonates might exacerbate differential access to and fair distribution of PHDM across NICUs. Respecting parental refusal may free up the supply of PHDM for the most needy preterm infants, and it may also result in an incrementally fairer allocation of PHDM to resource-limited institutions and underserved communities.

Shared decision-making in the NICU presents another reason to be cautious about overriding parental preferences for feeding. Consent for care in the NICU is rarely a one-time affair. Multiple care decisions are made across the span of hospitalization, many of which are frequently revisited. When parents and clinicians share the burden of decision-making, it creates opportunities for enhancing mutual trust and cooperation. Clinicians should therefore consider whether overriding parental preference for suboptimal treatments in the NICU might adversely impact a healthy dynamic moving forward. It would not be in the best interest of the neonate for tension, distrust, or nonadherence to result from unnecessary challenges to parental decisional authority.

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The takeaway

As Froh and Spatz rightly note, there are strong ethical reasons for clinicians to promote the utilization of PHDM in the NICU. As access to PHDM increases and safety measures further minimize health risks, we may eventually approach ideal circumstances in which, barring medical contraindications, PHDM for critically ill preterm neonates is obligatory. We are not there yet.

Nurses can play several important roles in the promotion of greater access to and utilization of PHDM in the NICU. For example, they need to understand why parents refuse PHDM. A common reason is that PHDM is “someone else's milk.”17 This could be a reaction of disgust or distress over the thought of one's infant receiving another mother's milk. A nurse may mitigate this by encouraging human milk feedings or providing families with information on the importance of PHDM, including the screening and pasteurization process.

The NICU nurse should be an integral member of the NICU team, compassionately building trust and educating parents about the benefits of PHDM. Further, nurses can work to optimize maternal milk expression by working for easier access to hospital-grade electric pumps, double collection kits, and customized shield sizing.18

As advocates for their patients, NICU nurses should also work toward a more just allocation of PHDM. They can vocally support fairer allocation of PHDM within their institutions and communities. As one of the most publicly trusted healthcare professionals, nurses can credibly advocate for the elimination of obstacles to accessing PHDM, particularly for underserved communities and resource-limited hospitals. This could involve raising public awareness about the need for more milk donors and the importance of public subsidies for this critical resource.19

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How is donor milk obtained and stored?20

Most PHDM utilized in North America is processed by one of 28 milk banks that adhere to the Human Milk Banking Association of North America donor screening and milk processing safety standards. Donated milk is pasteurized and screened, and donors are vetted through a process that includes questionnaires, medical records, and sometimes drug screening. These milk banks distribute PHDM under specific shipping guidelines, and hospitals are provided with instructions for safe storage. While the pasteurization process eliminates most pathogenic factors, it also destroys protective proteins and cells.

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