BACKGROUND AND OBJECTIVES:

Donor milk use has increased among very preterm infants because of mounting evidence of health benefits; however, the extent that donor milk is used among healthy term infants in level 1 nurseries is unclear. We aimed to determine (1) national prevalence of and (2) hospital factors associated with donor milk use in level 1 nurseries.

METHODS:

Among 3040 US birthing hospitals, we randomly selected hospitals from each of 4 US regions (119 in northeast, 120 in Midwest, 116 in west, and 103 in south) for a total of 458 hospitals. We surveyed the nursing leaders of these hospitals from October to December 2017 regarding routine use of donor milk in the level 1 nursery (yes or no). To estimate national prevalence, we weighted responses according to the number of birthing hospitals within each region. We examined relationships between routine donor milk use in the level 1 nursery and hospital characteristics using multivariable logistic regression.

RESULTS:

In total, 214 of 458 (47%) nursing leaders responded. The national prevalence of routine donor milk use in level 1 nurseries was 17.6%. Eighty-five percent of donor milk programs were ≤5 years old. Donor milk use occurred more often in hospitals with ≥1500 annual births (41.7%), compared to ≤500 annual births (6.3%) (adjusted odds ratio 7.8; 95% confidence interval 1.8–34.4), and in the west (30.9%), compared to the northeast (10.5%) (adjusted odds ratio 4.1; 95% confidence interval [1.1–14.9]).

CONCLUSIONS:

Although there is limited evidence to support donor milk for healthy infants in the nursery, nearly one-fifth of level 1 US nurseries routinely used donor milk in 2017.

Use of pasteurized donor milk for preterm infants has expanded dramatically in the past 15 years.14  This has been driven in large part by increasing evidence in support of donor milk to reduce important morbidities of prematurity5,6  and policy statements from the American Academy of Pediatrics7,8  and other professional organizations9,10  recommending donor milk when the mother’s milk is not available for preterm infants. Most studies in which authors examine the national prevalence of donor milk use have been restricted to level 3 and 4 NICUs,14  which are clinical settings used to care for very preterm infants.

In contrast, there is a paucity of data used to examine health outcomes of donor milk among healthy term infants. However, recent evidence suggests that donor milk use may be expanding to the level 1 nursery setting. A study published in 2018 in which authors examined donor milk use among level 1 nurseries in the northeast revealed that 29% of Massachusetts birth hospitals and 43% of hospitals served by the local northeastern nonprofit milk bank used donor milk in this setting.11  Generalizability of these findings to the rest of the United State is limited because responses were restricted to a single geographic area and donor milk use is known to vary by US region. Other evidence of dissemination of donor milk use in the level 1 nursery setting includes a published report of donor milk polices among 15 hospitals,12  a report of donor milk used to treat hypoglycemia13  and other conditions14  at a single center, and reports from individual hospitals describing their donor milk programs.1517 

Estimation of the national prevalence of donor milk programs in level 1 nurseries is needed to understand the extent that this practice has emerged in the past decade. Considering the paucity of studies used to examine health outcomes of donor milk use for healthy newborns, investigation of hospital characteristics that may be associated with donor milk programs, as well as rationale for and opinions about donor milk use for healthy term infants, is needed to understand what is driving this practice. In light of these current evidence gaps, the main aims of our study were to (1) determine national prevalence and (2) hospital factors associated with donor milk use among level 1 nurseries and (3) describe characteristics of donor milk programs. To understand the rationale for donor milk program adoption among level 1 nurseries, we also explored opinions regarding donor milk use.

We electronically surveyed nursing leaders of level 1 nurseries from a random selection of hospitals within US regions. To do this, we first obtained the 2015 American Hospital Association list of US hospitals and restricted our sample to those with >50 births per year, leaving 3040 hospitals (407 in the northeast, 901 in the Midwest, 684 in the west, and 1048 in the south). Our goal was to randomly select 120 hospitals among each US region for a total of 480 hospitals. Therefore, from our sample of eligible hospitals, we randomly sorted a list of hospitals within each region. We then ascertained the e-mail addresses of nursing leaders sequentially through Google searches and phone calls until we reached our goal numbers. Through this process, we ascertained 119 functional e-mail addresses from the northeast, 120 from the Midwest, 116 from the west, and 103 from the south for a total sample of 458 nursing leaders. In our final analysis, we included respondents who identified as a “nursing leader,” defined as “nurse manager, nurse educator, clinical nurse specialist, etc” and responded “yes” to the question, “Do you work in or oversee the care of infants receiving level 1 neonatal care?” We listed the American Academy of Pediatrics definitions of levels of neonatal care for reference.18  We chose to survey nursing leaders instead of physician leaders because level 1 nurseries consistently have nursing leaders overseeing clinical care and, in many level 1 nurseries, physicians rotate in and out.

We administered our 10- to 15-minute electronic survey to nursing leaders through an emailed link from October to December 2017. Nonresponders were recontacted a maximum of 5 times. As an incentive, we offered entry into a raffle for which we distributed a $500 ClinCard (prepaid MasterCard) to 1 randomly selected survey respondent from each US region. This study was approved as exempt from the institutional review board at the local institution of the first author, M.G.P.

Our survey was adapted from two previous surveys used to examine donor milk use among clinicians of neonatal care facilities.1,11  We asked questions in 3 domains: (1) beliefs about donor milk, (2) hospital characteristics, and (3) donor milk program characteristics (only asked among nursing leaders reporting that they had a donor milk program).

Our main outcome was donor milk program or not, as indicated by a yes or no response to the question, “Is pasteurized human donor milk routinely accessible for infants receiving level 1 neonatal care?” Regarding hospital characteristics, we included US region, defined as the northeast (reference), Midwest, south, and west per the US Census Bureau. The number of births per year was categorized as ≤500 (reference), 501 to 1500, and ≥1500. Safety-net hospital status was categorized as ≥75% of patients with Medicaid insurance (reference) versus <75% of patients with Medicaid insurance.19  Baby-Friendly hospital status was categorized as Baby-Friendly designated or on the pathway to obtain Baby-Friendly designation versus not on the pathway to obtain Baby-Friendly designation at this time (reference). We also examined report of The Joint Commission accreditation (yes of no). Beliefs about donor milk were ascertained by respondents’ opinions regarding various statements about donor milk according to the following choices: strongly agree, agree, disagree, strongly disagree, and unsure. We assessed opinions regarding health benefits and risks, costs, safety, perceived acceptability by hospital staff and families, and regulations.

Weighted analyses were used to account for stratification by region and provide more appropriate national estimates. After weighting, the regional distribution of hospitals in the sample matched the regional distribution of hospitals in the nation. First, we examined overall prevalence of donor milk programs among level 1 neonatal care facilities, which we refer to as “nurseries.” We then examined the prevalence of donor milk programs according to hospital characteristics. Multivariable logistic regression was used to examine the odds of having a donor milk program versus no program according to hospital characteristics. Hospital characteristics including region, safety-net status, level of neonatal care, Baby-Friendly designation, and The Joint Commission accreditation status were considered because of a priori interest. Region and safety-net hospital status were considered in our multivariate analysis because these factors have previously been associated with donor milk use in level 3 and 4 neonatal care facilities.1  We considered the highest level of neonatal care provided at the respondent’s hospital because we hypothesized that donor milk use in the nursery may be higher in hospitals that additionally provide level 3 or 4 neonatal care. Donor milk use in level 3 and 4 NICU settings is high (88% in a national study conducted in 2017)4 ; therefore, we hypothesized that donor milk use may be more familiar to staff at hospitals with level 3 and 4 NICUs and adoption of donor milk within the level 1 nursery setting may occur more readily. We also considered whether s Baby-Friendly hospital status was associated with donor milk use in the level 1 nursery setting because authors of a previous study found a trend toward higher use among nurseries in Baby-Friendly settings.11  Finally, we considered The Joint Commission accreditation because nurseries with donor milk programs may be able to report higher rates of exclusive breast milk feeding,20  which is a key target for The Joint Commission accreditation because donor milk is considered a type of breast milk per The Joint Commission definitions.21  All variables were included in our final model. Among hospitals with level 1 nursery donor milk programs, we examined descriptive characteristics of the programs. Finally, we examined bivariate relationships of opinions regarding donor milk among nursing leaders from hospitals with donor milk programs versus no programs using Rao-Scott χ2 tests. All analyses were conducted by using SAS (SAS Institute, Inc, Cary, NC) procedures for complex survey designs in SAS 9.4.

The overall response rate was 214 of 458 (47%). By region, the response rate was 57 of 119 (48%) in the northeast, 61 of 120 (51%) in the Midwest, 55 of 116 (47%) in the west, and 41 of 103 (40%) in the south. Existence of a level 1 nursery donor milk program was reported among 39 of 214 respondents, and the weighted US prevalence was 18%. In multivariate analysis, after adjusting for all hospital factors, we found that hospitals with level 1 nurseries in the west had higher odds of donor milk programs, compared to the northeast (adjusted odds ratio [OR] 4.1; 95% confidence interval [CI] 1.1–14.9), and those with >1500 births per year had higher odds of donor milk programs, compared with the hospitals with ≤500 births (adjusted OR 7.8; 95% CI 1.8–34.) (Table 1).

TABLE 1

2017 US Prevalence and Odds of Donor Milk Programs in Level 1 Nurseries According to Hospital Characteristics

All Hospitalsa (n = 214)Donor Milk Programsb (n = 39)Adjusted OR (95% CI) of Donor Milk Programs in Level 1 Nurseriesc
n (Weighted %d)n (Weighted %d)
US region    
 Northeast 57 (13.4) 6 (10.5) Reference 
 Midwest 61 (29.6) 12 (19.7) 2.1 (0.6–7.6) 
 South 41 (34.5) 4 (9.8) 0.8 (0.2–3.5) 
 West 55 (22.5) 17 (30.9) 4.1 (1.1–14.9)e 
Highest level of NICU care    
 Level 1 107 (49.4) 10 (8.0) Reference 
 Level 2 60 (27.7) 13 (20.6) 1.4 (0.5–4.3) 
 Level 3 or 4 47 (22.9) 16 (34.4) 1.4 (0.4–5.5) 
No. births per y    
 ≤500 85 (41.6) 6 (6.3) Reference 
 501–1500 74 (31.9) 14 (16.5) 2.0 (0.6–6.3) 
 >1500 46 (22.1) 18 (41.7) 7.8 (1.8–34.4)e 
 Do not know or missing 9 (4.4) 1 (11.0) — 
Safety-net hospital status    
 <75% Medicaid, non–safety net 130 (60.4) 26 (20.6) 1.8 (0.4–8.5) 
 ≥75% Medicaid, safety net 41 (20.8) 5 (8.5) Reference 
 Do not know or missing 43 (18.9) 8 (17.6) — 
Baby-Friendly status    
Baby-Friendly designated or on pathway 95 (45.1) 23 (21.3) 1.2 (0.5–2.9) 
Not designated or on the pathway 107 (49.8) 15 (15.0) Reference 
Do not know or missing 12 (5.1) 1 (9.5) — 
Joint commission accreditation    
 Yes 158 (74.9) 35 (21.3) 2.2 (0.5–9.7) 
 No 45 (19.7) 3 (5.7) Reference 
 Do not know or missing 11 (5.4) 1 (9.0) — 
All Hospitalsa (n = 214)Donor Milk Programsb (n = 39)Adjusted OR (95% CI) of Donor Milk Programs in Level 1 Nurseriesc
n (Weighted %d)n (Weighted %d)
US region    
 Northeast 57 (13.4) 6 (10.5) Reference 
 Midwest 61 (29.6) 12 (19.7) 2.1 (0.6–7.6) 
 South 41 (34.5) 4 (9.8) 0.8 (0.2–3.5) 
 West 55 (22.5) 17 (30.9) 4.1 (1.1–14.9)e 
Highest level of NICU care    
 Level 1 107 (49.4) 10 (8.0) Reference 
 Level 2 60 (27.7) 13 (20.6) 1.4 (0.5–4.3) 
 Level 3 or 4 47 (22.9) 16 (34.4) 1.4 (0.4–5.5) 
No. births per y    
 ≤500 85 (41.6) 6 (6.3) Reference 
 501–1500 74 (31.9) 14 (16.5) 2.0 (0.6–6.3) 
 >1500 46 (22.1) 18 (41.7) 7.8 (1.8–34.4)e 
 Do not know or missing 9 (4.4) 1 (11.0) — 
Safety-net hospital status    
 <75% Medicaid, non–safety net 130 (60.4) 26 (20.6) 1.8 (0.4–8.5) 
 ≥75% Medicaid, safety net 41 (20.8) 5 (8.5) Reference 
 Do not know or missing 43 (18.9) 8 (17.6) — 
Baby-Friendly status    
Baby-Friendly designated or on pathway 95 (45.1) 23 (21.3) 1.2 (0.5–2.9) 
Not designated or on the pathway 107 (49.8) 15 (15.0) Reference 
Do not know or missing 12 (5.1) 1 (9.5) — 
Joint commission accreditation    
 Yes 158 (74.9) 35 (21.3) 2.2 (0.5–9.7) 
 No 45 (19.7) 3 (5.7) Reference 
 Do not know or missing 11 (5.4) 1 (9.0) — 

—, not applicable.

a

Percentages shown are the percentages of all hospitals with each characteristic.

b

Percentages shown are the percentages of hospitals with the specified characteristic that have donor milk programs.

c

Adjustment for all hospital factors listed in the table.

d

Responses weighted by the number of birth hospitals in each region.

e

Statistical significance.

When we examined donor milk program characteristics (Table 2), we found that 29% of programs were <2 years old and 56% were 2 to 5 years old. Most nurseries with donor milk programs have signed consents (83%) typically obtained by nurses (66%), pay for donor milk out of hospital budgets (86%), and obtain donor milk from nonprofit milk banks (91%). When asked why nurseries began offering donor milk, 86% reported health benefits for infants in the nursery, 76% reported that donor milk is a better alternative than formula, and 74% reported that donor milk increases the rate of human breast milk exclusivity.

TABLE 2

Characteristic of 39 Donor Milk Programs in Level 1 Nurseries

Characteristicsn (Weighted %)
Time since donor milk program initiation, y  
 <2 9 (29.0) 
 2–5 17 (55.7) 
 6–10 4 (12.4) 
 ≥11 1 (2.8) 
Consent process  
 Signed consent 33 (82.7) 
 Verbal consent 4 (12.2) 
 No consent 2 (5.1) 
Personnel that typically obtains consent  
 MDs or NPs 6 (10.4) 
 RNs 24 (66.4) 
 MDs, NPs, or RNs 7 (18.1) 
 We do not typically obtain consent 2 (5.1) 
Approximate rate of parental refusal  
 <10% 18 (44.6) 
 10%–25% 7 (17.2) 
 ≥26% 3 (8.9) 
 I do not know 11 (29.3) 
Source of payment (check all that apply)a  
 Hospital budget 33 (85.7) 
 Insurance reimbursement 3 (7.4) 
 Internal grant 3 (7.4) 
Source of donor milkb  
 Nonprofit milk bank 36 (90.6) 
 Other 3 (9.4) 
Reasons your nurseries began offering donor milk (check all that apply)c  
 Health benefits for infants receiving level 1 neonatal care 32 (86.2) 
 Parent request 16 (40.8) 
 Donor milk is a better alternative than formula 30 (76.2) 
 Donor milk use improves our rate of human breast milk exclusivity 29 (74.3) 
Criteria for donor milk use (check all that apply)d  
 Mother ineligible to provide her own milk per hospital criteria 29 (75.8) 
 Infant requires supplementation for any reason 34 (87.4) 
 Infant below a specified gestational age 14 (35.3) 
 <37 wke 5 (31.4) 
 Infant below a specified birth wt 12 (27.7) 
 <4000 ge 5 (40.0) 
 Infant has a specific conditionf 23 (55.6) 
 Severe wt loss 22 (53.2) 
 Hyperbilirubinemia requiring phototherapy 18 (42.6) 
 Hypoglycemia 23 (55.6) 
 Parent request 27 (67.8) 
 Other reasong 4 (12.7) 
Characteristicsn (Weighted %)
Time since donor milk program initiation, y  
 <2 9 (29.0) 
 2–5 17 (55.7) 
 6–10 4 (12.4) 
 ≥11 1 (2.8) 
Consent process  
 Signed consent 33 (82.7) 
 Verbal consent 4 (12.2) 
 No consent 2 (5.1) 
Personnel that typically obtains consent  
 MDs or NPs 6 (10.4) 
 RNs 24 (66.4) 
 MDs, NPs, or RNs 7 (18.1) 
 We do not typically obtain consent 2 (5.1) 
Approximate rate of parental refusal  
 <10% 18 (44.6) 
 10%–25% 7 (17.2) 
 ≥26% 3 (8.9) 
 I do not know 11 (29.3) 
Source of payment (check all that apply)a  
 Hospital budget 33 (85.7) 
 Insurance reimbursement 3 (7.4) 
 Internal grant 3 (7.4) 
Source of donor milkb  
 Nonprofit milk bank 36 (90.6) 
 Other 3 (9.4) 
Reasons your nurseries began offering donor milk (check all that apply)c  
 Health benefits for infants receiving level 1 neonatal care 32 (86.2) 
 Parent request 16 (40.8) 
 Donor milk is a better alternative than formula 30 (76.2) 
 Donor milk use improves our rate of human breast milk exclusivity 29 (74.3) 
Criteria for donor milk use (check all that apply)d  
 Mother ineligible to provide her own milk per hospital criteria 29 (75.8) 
 Infant requires supplementation for any reason 34 (87.4) 
 Infant below a specified gestational age 14 (35.3) 
 <37 wke 5 (31.4) 
 Infant below a specified birth wt 12 (27.7) 
 <4000 ge 5 (40.0) 
 Infant has a specific conditionf 23 (55.6) 
 Severe wt loss 22 (53.2) 
 Hyperbilirubinemia requiring phototherapy 18 (42.6) 
 Hypoglycemia 23 (55.6) 
 Parent request 27 (67.8) 
 Other reasong 4 (12.7) 

MD, medical doctor; NP, nurse practitioner; RN, registered nurse.

a

Other responses were external grant (n = 1), parents pay out of pocket (n = 1), and no charge (n = 1).

b

Other responses were Medolac (n = 2) and Evolve BioSystems (n = 1). There were 0 responses for Prolacta.

c

Other responses were “to attain Baby-Friendly status” (n = 1), “for those that desire exclusive breastfeeding but require supplementation” (n = 1), and “high rate of gestational diabetes, donor milk stabilizes blood sugars; use when mothers are not creating enough milk” (n = 1).

d

Other responses were growth restriction (n = 2), physician preference (n = 4), twin (n = 2), congenital heart disease (n = 2), critical illness or extracorporeal membrane oxygenation (n = 2), and all infants (n = 5).

e

Most commonly reported answer.

f

Other specific conditions were polycythemia (n = 5), neonatal abstinence syndrome (n = 1), and any mother-infant separation (n = 1).

g

Other reasons included physician discussion with mother (n = 1), “MD order” (n = 1), “maternal issues” (n = 1), and trial period criteria are hypoglycemia, hyperbilirubinemia, ≥10% wt loss (n = 1).

Opinions of nursing leaders regarding donor milk are shown in Table 3. Notably, the majority of respondents agreed or strongly agreed that studies revealed health benefits of providing donor milk to healthy term infants (73% with donor milk programs and 80% without), that using donor milk was an effective way to increase the rate of exclusive breastfeeding in the hospital (87% with donor milk programs and 74% without), and that donor milk was a better alternative than formula for infants cared for in the level 1 nursery (96% with donor milk programs and 88% without). Nursing leaders without donor milk programs were more often unsure about the adequacy of milk banking regulations, receptivity of parents and staff, and costs compared with those with donor milk programs.

TABLE 3

Opinions of US Nursing Leaders Regarding Donor Milk Use in Level 1 Nurseries

Agree or Strongly Agree, n (%)Disagree or Strongly Disagree, n (%)Unsure, n (%)P a
Studies reveal health benefits of providing donor milk to very preterm infants    .75 
 Donor milk program 36 (92.7) 0 (0) 2 (7.3)  
 No program 154 (90.7) 0 (0) 16 (9.3)  
Studies show health benefits of providing donor milk to late preterm infants    .75 
 Donor milk program 36 (92.7) 1 (2.4) 1 (4.9)  
 No program 149 (88.7) 3 (1.9) 17 (9.4)  
Studies reveal health benefits of providing donor milk to healthy term infants    .63 
 Donor milk program 29 (73.4) 3 (7.2) 6 (19.4)  
 No program 134 (80.2) 8 (4.2) 28 (15.6)  
Studies reveal health risks of providing donor milk to infants (term or preterm)    .01 
 Donor milk program 5 (11.9) 29 (76.6) 4 (11.5)  
 No program 45 (26.9) 79 (47.8) 46 (25.3)  
Using donor milk is an effective way to increase the exclusive breastfeeding rate for infants receiving level 1 neonatal care    .22 
 Donor milk user 32 (86.6) 3 (7.2) 3 (6.2)  
 Donor milk nonuser 124 (74.0) 25 (15.1) 21 (10.9)  
Donor milk use among infants receiving level 1 neonatal care increases breastfeeding exclusivity after discharge    .37 
 Donor milk user 25 (68.4) 6 (14.4) 7 (17.3)  
 Donor milk nonuser 90 (56.5) 26 (16.0) 54 (27.6)  
Donor milk is nutritionally adequate for infants receiving level 1 neonatal care    .18 
 Donor milk user 37 (98.6) 0 (0) 1 (1.4)  
 Donor milk nonuser 148 (89.1) 4 (1.9) 18 (8.9)  
Donor milk is a better alternative than formula for infants receiving level 1 neonatal care    .24 
 Donor milk user 36 (95.8) 1 (2.8) 1 (1.4)  
 Donor milk nonuser 144 (87.5) 11 (5.5) 15 (7.0)  
The cost of donor milk is justified by its benefits for infants receiving level 1 neonatal care    <.001 
 Donor milk user 34 (91.0) 1 (2.4) 3 (6.6)  
 Donor milk nonuser 79 (48.2) 29 (15.9) 62 (35.9)  
Banked human donor milk is safe for infants receiving level 1 neonatal care    .16 
 Donor milk user 37 (98.6) 0 (.) 1 (1.4)  
 Donor milk nonuser 147 (86.9) 2 (1.1) 21 (11.9)  
Parents in our hospital are receptive to using donor milk for their infants receiving level 1 neonatal care    <.001 
 Donor milk user 36 (97.2) 1 (1.4) 1 (1.4)  
 Donor milk nonuser 28 (19.0) 28 (14.9) 114 (66.1)  
Nurses in our hospital are receptive to using donor milk for infants receiving level 1 neonatal care    <.001 
 Donor milk user 36 (97.2) 1 (1.4) 1 (1.4)  
 Donor milk nonuser 67 (43.3) 22 (11.8) 81 (44.9)  
Physicians and nurse practitioners in our hospital are receptive to using donor milk for to infants receiving level 1 neonatal care    <.001 
 Donor milk user 34 (88.5) 3 (10.2) 1 (1.4)  
 Donor milk nonuser 55 (34.4) 27 (16.6) 88 (49.0)  
Although there is no federal regulation of milk banking, the guidelines followed by US milk banks are adequate    <.001 
 Donor milk user 36 (96.2) 1 (2.4) 1 (1.4)  
 Donor milk nonuser 85 (50.6) 5 (3.9) 80 (45.6)  
Agree or Strongly Agree, n (%)Disagree or Strongly Disagree, n (%)Unsure, n (%)P a
Studies reveal health benefits of providing donor milk to very preterm infants    .75 
 Donor milk program 36 (92.7) 0 (0) 2 (7.3)  
 No program 154 (90.7) 0 (0) 16 (9.3)  
Studies show health benefits of providing donor milk to late preterm infants    .75 
 Donor milk program 36 (92.7) 1 (2.4) 1 (4.9)  
 No program 149 (88.7) 3 (1.9) 17 (9.4)  
Studies reveal health benefits of providing donor milk to healthy term infants    .63 
 Donor milk program 29 (73.4) 3 (7.2) 6 (19.4)  
 No program 134 (80.2) 8 (4.2) 28 (15.6)  
Studies reveal health risks of providing donor milk to infants (term or preterm)    .01 
 Donor milk program 5 (11.9) 29 (76.6) 4 (11.5)  
 No program 45 (26.9) 79 (47.8) 46 (25.3)  
Using donor milk is an effective way to increase the exclusive breastfeeding rate for infants receiving level 1 neonatal care    .22 
 Donor milk user 32 (86.6) 3 (7.2) 3 (6.2)  
 Donor milk nonuser 124 (74.0) 25 (15.1) 21 (10.9)  
Donor milk use among infants receiving level 1 neonatal care increases breastfeeding exclusivity after discharge    .37 
 Donor milk user 25 (68.4) 6 (14.4) 7 (17.3)  
 Donor milk nonuser 90 (56.5) 26 (16.0) 54 (27.6)  
Donor milk is nutritionally adequate for infants receiving level 1 neonatal care    .18 
 Donor milk user 37 (98.6) 0 (0) 1 (1.4)  
 Donor milk nonuser 148 (89.1) 4 (1.9) 18 (8.9)  
Donor milk is a better alternative than formula for infants receiving level 1 neonatal care    .24 
 Donor milk user 36 (95.8) 1 (2.8) 1 (1.4)  
 Donor milk nonuser 144 (87.5) 11 (5.5) 15 (7.0)  
The cost of donor milk is justified by its benefits for infants receiving level 1 neonatal care    <.001 
 Donor milk user 34 (91.0) 1 (2.4) 3 (6.6)  
 Donor milk nonuser 79 (48.2) 29 (15.9) 62 (35.9)  
Banked human donor milk is safe for infants receiving level 1 neonatal care    .16 
 Donor milk user 37 (98.6) 0 (.) 1 (1.4)  
 Donor milk nonuser 147 (86.9) 2 (1.1) 21 (11.9)  
Parents in our hospital are receptive to using donor milk for their infants receiving level 1 neonatal care    <.001 
 Donor milk user 36 (97.2) 1 (1.4) 1 (1.4)  
 Donor milk nonuser 28 (19.0) 28 (14.9) 114 (66.1)  
Nurses in our hospital are receptive to using donor milk for infants receiving level 1 neonatal care    <.001 
 Donor milk user 36 (97.2) 1 (1.4) 1 (1.4)  
 Donor milk nonuser 67 (43.3) 22 (11.8) 81 (44.9)  
Physicians and nurse practitioners in our hospital are receptive to using donor milk for to infants receiving level 1 neonatal care    <.001 
 Donor milk user 34 (88.5) 3 (10.2) 1 (1.4)  
 Donor milk nonuser 55 (34.4) 27 (16.6) 88 (49.0)  
Although there is no federal regulation of milk banking, the guidelines followed by US milk banks are adequate    <.001 
 Donor milk user 36 (96.2) 1 (2.4) 1 (1.4)  
 Donor milk nonuser 85 (50.6) 5 (3.9) 80 (45.6)  

Responses weighted by number of birth hospitals in each region.

a

Rao-Scott χ2 test.

In a nationally representative survey of nursing leaders, we found that 18% of level 1 nurseries routinely used donor milk in 2017. Eighty-five percent of programs were ≤5 years old. Level 1 nursery donor milk programs occurred more often among hospitals in the west and among those with greater annual births. The predominant reasons why donor milk programs were initiated included perceived health benefits for infants receiving level 1 neonatal care, beliefs that donor milk is a better alternative than formula, and beliefs that donor milk improves the rate of human breast milk exclusivity. Our study aligns with previous local and regional reports of increasing donor milk use in the level 1 nursery setting11,12,1517 ; however, in our study, we expand on past work by examining donor milk use at a national level and examine hospital characteristics associated with use.

Donor milk use appears to be rapidly expanding to include the healthy US newborn population. Like any other novel clinical practice, clinicians need to consider several factors before considering adoption, including evidence of health outcomes, staff and patient perception of acceptability, costs, feasibility, and incentive structures.

Regarding health outcomes, it is important to consider health risks and benefits for both donor milk and formula when used as a supplement to a mother’s milk in the nursery setting to inform decision-making regarding expansion of donor milk programs for this purpose. In our study, we found that donor milk was used to treat several medical conditions, such as severe weight loss, hyperbilirubinemia, and hypoglycemia; however, studies in which authors examine the effectiveness of treating these conditions with donor milk and whether donor milk is less, as, or more effective than formula are lacking. Regarding potential risks of formula, formula exposure may lead to unfavorable alterations of the infant microbiome that may contribute to the development of future chronic disease.22  However, in a randomized controlled trial of early limited formula supplementation for medical need, Flaherman et al23  reported no decrease in abundance of Lactobacillus and Bifidobacterium and no increase in Clostridium in breastfed term infants who received small volumes of early formula supplementation compared with those who received none. It is also possible that formula supplementation in the first days of life should be avoided to avoid cow’s milk sensitization24  or other allergic disease states.25  Overall, there is a crucial need for more studies examining trade-offs of health risks and benefits of donor milk and formula used during the nursery time period.

The impact of early donor milk use on lactation outcomes should also be considered. Although authors of observational studies suggest that early formula use is associated with shorter duration of any breastfeeding,2628  authors of randomized controlled trials of early, limited formula found no negative impact on breastfeeding rates at 1, 3, and 6 months postpartum,23,29  suggesting that it may be the supplementation protocol, not the supplement, that influences breastfeeding outcomes. In our study, we found that donor milk is typically provided as a supplement to the mother’s own milk for a specific medical indication, suggesting that interference with breastfeeding in the first days after birth may not be substantial. Like the studies of early, limited formula use, Kair et al30  demonstrated no difference in lactation at 1, 2, and 3 months after early, limited donor milk supplementation for weight loss during the level 1 nursery time period, indicating that donor milk used as a supplement may not greatly impact duration of lactation. In a recent single-center retrospective pre-post study used to examine the impact of exclusive breastfeeding at 6 months after implementation of a donor milk program in the level 1 nursery, researchers found increased exclusive breastfeeding at 6 months of age among infants who received donor milk supplementation compared with those who received formula supplementation.31  Further studies used to examine the extent that donor milk supplementation may impact longer-term breastfeeding outcomes at the population level are needed.

Staff perceptions of donor milk as a component of a larger platform for breastfeeding support in the level 1 nursery setting is an important consideration. Studies have revealed that many level 3 NICUs that introduced donor milk programs for very low birth weight infants found increases in the mother’s own milk use.32,33  Authors of a 2015 national study similarly found that the prevalence of donor milk use was higher among hospitals with higher rates of the mother’s own milk.3  This may represent an increased awareness of the importance of breastfeeding among staff and translate to further support for mothers in making their own milk. Many nursing directors in our study agreed that donor milk was a better alternative than formula. Currently, the extent that introduction of donor milk programs may change the rate of any and exclusive mother’s own milk feeding in the level 1 nursery is unclear. Current definitions of exclusive breast milk feeding per The Joint Commission definitions and for Baby-Friendly hospital designation do not differentiate donor milk and the mother’s own milk as types of “breast milk” in reporting. Differentiating these would enable assessment of the impact of donor milk programs on the mother’s milk feedings in the level 1 nursery setting.

In addition to staff beliefs and adoption of breastfeeding support practices, patient acceptability and interest in donor milk use are also important to think about. In recent qualitative studies of mothers, authors reported a range of perceptions including beliefs that donor milk was temporary and formula was the ongoing plan, donor milk was unfamiliar, and donor milk was “healthier” and “natural.”34,35  In recent studies, researchers have also reported lower use of donor milk in the level 1 nursery setting among nonwhite,14,36  non–English-speaking mothers36  and those with public insurance,14,36  suggesting that maternal cultural differences or biases against donor milk use may exist or that nursery providers may have biases in delivery of education or recommendations for donor milk use toward certain groups of mothers.

In addition, donor milk is expensive (∼$4.50/floz from nonprofit milk banks in North America), and our study reveals that 86% of hospitals are paying from their own budgets. Resources to support lactation services are not unlimited in the hospital settings. Hospital leaders must weigh the costs of provision of donor milk with costs for lactation personnel, pumping supplies, and so forth. Clinicians must also consider the resources spent in initiating donor milk programs. This involves developing policies that outline criteria for use, protocols for milk storage, training staff, and implementing processes for securing donor milk.12,17 

Finally, incentive structures may drive decisions to initiate donor milk programs in level 1 nurseries. Hospitals have tremendous pressure to increase their exclusive breast milk feeding rates. Exclusive breast milk feeding during the level 1 nursery hospitalization is a key metric in The Joint Commission and is reported to Centers for Disease Control and Prevention’s Maternity Practices in Infant Nutrition and Care. As mentioned above, donor milk supplementation is included in the definition of “exclusive breast milk feeding,” whereas formula supplementation is not. Indeed, we found that a high proportion of survey respondents (87% respondents with donor milk programs and 74% without) reported that donor milk use was an effective way to increase the exclusive breastfeeding rate.

Strengths of our study include the sampling strategy, which enabled the estimate of a national prevalence of level 1 nursery donor milk programs. We also considered an array of hospital characteristics that may be associated with donor milk programs, making the results of our study more generalizable. Our overall response rate was 45%, which was greater than other national survey studies of perinatal nurses.37,38  A limitation is that nursing leaders self-reported information about their hospitals and sometimes did not know the answers to questions. Selection bias among respondents was possible. Nursing leaders with donor milk programs may have been more interested in the topic and more likely to respond. The survey itself was adapted from two previous surveys and pilot tested with several physicians but was not validated in other ways.

Donor milk programs have rapidly emerged in the level 1 nursery setting, representing a drift from the steady increase in donor milk use in the level 3 and 4 NICU setting. Further adoption of donor milk use among the healthy newborn population should be thoughtfully considered going forward. Although the ultimate public health goal is to support maximal duration of lactation and health benefits for mother-infant dyads, evidence that donor milk on its own or as a supplement to the mother’s own milk for healthy newborns leads to this goal is limited. We suggest that The Joint Commission and other organizations measure mothers’ milk exclusivity separate from human milk exclusivity to further investigate the impact of donor milk use in the level 1 nursery setting. When limited resources are available for lactation support in the level 1 nursery, more information is needed to make informed decisions regarding allocation of resources to donor milk programs versus enhancing other forms of lactation support.

We acknowledge Adriana Lopera, Anna Walsh, and Thea Lacerta for assistance in identifying nursing leaders.

Dr Parker conceptualized and designed the study, interpreted the data, drafted the initial manuscript, and reviewed and revised the manuscript; Drs Belfort, Perrin, and Corwin interpreted the data and critically revised the manuscript for important intellectual content; Ms Burnham and Mr Kerr assisted with acquisition and interpretation of the data and critically revised the manuscript for important intellectual content; Dr Heeren conceptualized and designed the study, interpreted the data, drafted the initial manuscript, and reviewed the revised the manuscript; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work

FUNDING: Supported by the W.K. Kellogg Foundation (P3031871). The funder/sponsor did not participate in the work.

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Competing Interests

POTENTIAL CONFLICT OF INTEREST: Dr Perrin serves on the board of directors of the Human Milk Banking Association of North America. Drs Parker and Belfort serve on the research board of Mother’s Milk Bank Northeast. These are all unpaid positions. The other authors have indicated they have no potential conflicts of interest to disclose

FINANCIAL DISCLOSURES: The authors have indicated they have no financial relationships relevant to this article to disclose.