Journal of Human Lactation http://jhl.sagepub.com/
The Effect of a Donor Milk Policy on the Diet of Very Low Birth Weight Infants Kathleen A. Marinelli, Mary M. Lussier, Elizabeth Brownell, Victor C. Herson and James I. Hagadorn J Hum Lact published online 18 April 2014 DOI: 10.1177/0890334414530511 The online version of this article can be found at: http://jhl.sagepub.com/content/early/2014/04/18/0890334414530511
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research-article2014
JHLXXX10.1177/0890334414530511Journal of Human LactationMarinelli et al
Original Research
The Effect of a Donor Milk Policy on the Diet of Very Low Birth Weight Infants
Journal of Human Lactation 1–7 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0890334414530511 jhl.sagepub.com
Kathleen A. Marinelli, MD, IBCLC1,2,3, Mary M. Lussier, BSN, IBCLC1,2, Elizabeth Brownell, PhD, MA1,2,3, Victor C. Herson, MD1,2,3, and James I. Hagadorn, MD, MS1,2,3
Abstract Background: Use of donor milk (DM) to supplement mother’s own milk (MOM) in the neonatal intensive care unit (NICU) is steadily increasing based on health and developmental benefits to premature infants. A paucity of data exists documenting the effect of DM use on the diet of very low birth weight (VLBW) infants related to the implementation of a DM policy. Objective: This study aimed to compare VLBW enteral intake type in the first 28 days of life before versus after establishing a DM policy. Methods: This single-center pre–post prospective cohort study included all inborn infants ≤ 1500 grams in a level 4 NICU remaining hospitalized at 28 days and admitted either before (pre-DM period, October 2009–March 2010) or after (DM period, October 2010–September 2012) implementing a DM policy. The feeding protocol was unchanged in both periods. Collected data included maternal/infant demographics, infant clinical data, and daily volume of enteral intake as MOM, DM, and formula. The proportion of enteral feeds from these sources during the first 28 days of life was compared pre-DM versus DM. Results: Compared to pre-DM baseline, formula exposure was significantly decreased, and human milk exposure and proportion of diet as human milk increased. The proportion of infants fed exclusively human milk increased. Exposure to and proportion of diet as MOM was unchanged. Infants were fed earlier in the DM period. Conclusion: Establishment of a DM policy was associated with reduced exposure to formula, promoting an exclusively human milk diet, with earlier initiation of feeds and no decrease in use of MOM. Keywords breastfeeding, donor milk, human milk, nutrition, premature infant, very low birth weight infant
Well Established The protective effects of human milk for premature infants are well known. Although donor milk use in neonatal intensive care units is increasing, its effect on the diet of very low birth weight (VLBW) infants is largely unknown.
Newly Expressed Establishing a donor milk policy for VLBW infants is associated with reduced formula and increased human milk exposure, increased proportion of diet as human milk, and earlier start of enteral feeds with no decrease in the use of mother’s own milk observed.
may not be able to express colostrum in the first postpartum days or ultimately achieve an adequate supply for their infants for a number of well-recognized reasons, including initiating and maintaining expression with a mechanical pump, fatigue, stress, and maternal illness.20,22-26 As a result, use of donor milk (DM) as either a supplement to mother’s own milk (MOM) or an exclusive diet for infants who receive
1
The Connecticut Human Milk Research Center, Hartford, CT, USA Division of Neonatology, Connecticut Children’s Medical Center, Hartford, CT, USA 3 Department of Pediatrics, University of Connecticut School of Medicine, Farmington, CT, USA 2
Date submitted: June 3, 2013; Date accepted: March 13, 2014.
Background The health and developmental benefits of human milk for very low birth weight (VLBW, ≤ 1500 grams) infants are well documented.1-21 However, mothers of preterm infants
Corresponding Author: Kathleen A. Marinelli, MD, IBCLC, 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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no mother’s milk is increasing, as are the number of neonatal intensive care units (NICUs) implementing DM policies.27 Despite the recent increase in DM utilization, several aspects regarding the implementation of a DM policy in the NICU remain undocumented. A speculative concern has been voiced among neonatologists that introducing DM may discourage maternal efforts to produce their own milk. In addition, the effect of establishing a DM policy in a NICU on the VLBW diet over the first 28 days of life is still unexplored. The purpose of this study was to examine the association between the introduction of a DM policy for supplementation of MOM and the intake of human milk and formula over the first 28 days of life among VLBW infants.
Methods Sample This study was conducted in the Connecticut Children’s Medical Center’s 32-bed level 4 NICU in Hartford, Connecticut. The Connecticut Children’s Institutional Review Board determined this study to be exempt from oversight. Data were collected prospectively over 2 study periods. Baseline data were collected for 6 months (October 1, 2009– March 31, 2010) prior to adoption of the DM policy (preDM). A 6-month washout period followed, allowing for policy development and implementation, staff education, and acclimation. Data collection then resumed October 1, 2010 to September 30, 2012, the period when DM became the preferred alternative. All inborn infants with birth weight ≤ 1500 grams admitted during 1 of the 2 study periods and remaining hospitalized at 28 days of life were included in the study. Data recorded included maternal and infant demographics, volume and type (MOM, DM, formula, and total human milk) of enteral feeding per day, and hour of life of initiation of enteral feeding (calculated from the hour of birth and the documented time of first feed on a daily bedside recording sheet). Illness severity was compared between groups with positive pressure respiratory support and nasal cannula days as proxies for this comparison. All data were obtained from the infant’s written and electronic medical records and recorded on individual data collection sheets. Data abstractors were 3 NICU lactation consultants (LCs), all previously trained and employed as NICU registered nurses at Connecticut Children’s, or 1 neonatologist. One LC and the neonatologist did spot checks to evaluate the internal validity of the data.
Design On August 1, 2010, the Connecticut Children’s NICU officially adopted a policy of providing DM as the preferred alternative if MOM is not available in sufficient quantity to
meet her infant’s need. We use the term preferred alternative as opposed to standard of care as we require informed consent. Our NICU infants are eligible to receive DM if they are born ≤ 1800 grams or ≤ 32 weeks gestation. Per policy, all VLBW infants may receive DM for up to 10 weeks or until they achieve 50% of full oral feedings, whichever comes first. The study end-point of 28 days was chosen to avoid attrition due to transfer or discharge home. Prior to initiating the DM policy, all neonatologists and clinical staff were educated and remain well-versed in the DM policy and eligibility. Discussions of the importance of human milk for premature infants begin as soon as we meet the parents. This can be in a scheduled prenatal consult; on the high-risk antenatal in-patient unit; on labor and delivery if time allows prior to delivery; or on labor and delivery, in mother’s postpartum room, or at the infant’s bedside if delivery has occurred in emergent circumstances. We discuss the importance of MOM and of our commitment to helping each mother reach her potential in milk production unless there is a reason not to use her milk. We talk about human milk as being “medicine” for her infant, especially her colostrum, and educate on the importance of MOM for nutrition, immune function, and neurodevelopment specifically. We then inform the family of our DM policy, particularly that it is in support of our maternal breast milk/breastfeeding program. A standard feeding protocol had been introduced to this NICU prior to the DM policy (Table 1). That protocol was followed in both study periods and was not modified during the study. We discuss that it is common to need some DM at the very beginning when we start feedings within the first 48 hours after birth as per our feeding protocol (Table 1), when many mothers even using hand expression do not express enough milk to start feeds, and then again about a month out when infants often have advanced on feeds exceeding mother’s milk supply. Parental concerns are addressed by any of the clinical staff. Informed consent is obtained from parents by the attending neonatologists, nurse practitioners, physician assistants, or NICU lactation consultants. The incremental cost of the DM is covered by the hospital per diem charge and is not a separate reimbursable expense.
Statistical Analysis Categorical data from the DM period were compared to the pre-DM baseline using chi-square test with continuity correction. Fisher exact test was used for comparisons of categorical data where counts in individual cells were less than 5. Mann–Whitney U test was used for comparison of continuous data to avoid assumption of normal distribution. Multivariate logistic regression was used to examine the adjusted relationship between the study’s categorical dietary outcomes in DM as compared to pre-DM. Linear regression was used similarly to examine continuous outcomes. Variables were included in regression analyses based
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Marinelli et al Table 1. Connecticut Children’s Medical Center Feeding Protocol.a Initiation of Feeds
Amount
Route
Substrate
Advancement
Fortification
< 1000 g
By 48 h of life
10 mL/kg/d
Bolus divided Q6h
Human milk or preterm formula
Start at 100 mL/ kg/d enteral feeds
1000-1500 g
By 48 h of life
15 mL/kg/d
Bolus divided Q3h
Human milk or preterm formula
On day 4 ↑ to 20 mL/ kg/d for 3 d, divided Q 4 h; then ↑ by 1520 mL/kg/d Q 24 h, divided Q 3 h After 3 days, ↑ 15-20 mL/kg/d Q 24 h
Birth Weight
Start at 100 mL/ kg/d enteral feeds
Abbreviation: Q, every. a Feeds held for bloody stool; bilious emesis; abdominal distention; cardiovascular instability, ie, acidosis or hypotension requiring medications; significant apnea and bradycardia; hemodynamically significant patent ductus arteriosis (PDA) requiring use of medications. Practitioner notified if aspirate obtained Q 6 hours is > 50% of previous 6-hour volume delivered.
Table 2. Study Cohort Demographics. Pre-DM N Maternal age, median (25th, 75th percentiles), y Primigravid mother, No. (%) Birth weight, median (25th, 75th percentiles), g Gestational age, median (25th, 75th percentiles), wk Multiples, No. (%) Female, No. (%) Insurance, No. (%) Private State Race/ethnicity, No. (%) White Black Hispanic Other Ventilator days (first 28 d), median (25th, 75th percentiles) CPAP days (first 28 d), median (25th, 75th percentiles) Days on nasal cannula (first 28 d), median (25th, 75th percentiles) Hours to first feed, median (25th, 75th percentiles)b
32 30 (25.3, 33.0) 5 (15.6) 900 (771, 1216) 26.6 (25.5, 29.0) 12 (37.5) 20 (62.5) 19 (59.4) 13 (40.6)
DM
P Valuea
122 29 (23.8, 33.0) 44 (36.1) 1115 (860, 1290) 29.0 (27.0, 31.1) 31 (25.4) 68 (55.7)
.310 .030 .100 .001 .256 .550 .233 .142 .110 .750 .040 .017
56 (49.5) 56 (49.5)
19 (59.4) 46 (37.7) 7 (21.9) 34 (27.9) 4 (12.5) 33 (27.0) 2 (6.3) 9 (7.3) 2.5 (1.0, 17.5) 2.0 (0.0, 8.0) 7.5 (6.0, 19.0) 8.0 (2.0, 20.0) 0 (0.0, 5.5) 0 (0.0, 0.0) 52 (42.5, 61.3) (N = 26) 42 (31.0, 52.0) (N = 88)
Abbreviations: CPAP, continuous positive airway pressure; DM, donor milk. a Chi-square with continuity correction, Fisher exact, or Mann–Whitney U. b Infants excluded whose feeds were held appropriately according to feeding protocol (see Table 1).
on previous research demonstrating possible association (necrotizing enterocolitis [NEC], birth weight, days on continuous positive airway pressure in the first 28 days of life, days on ventilator in the first 28 days of life, sex, and time to first feed)12,17,18,25,28 or if they were significant in univariate analysis (gestational age, maternal primigravid status, and days of nasal cannula oxygen in the first 28 days of life.). All tests were 2-sided, with P < .05 considered statistically significant.
Results There were 32 infants in the 6-month pre-DM group and 122 in the 24-month DM group (Table 2). Mothers in the pre-DM
group were significantly less likely to be primigravid, and their infants were significantly more premature than the DM group. The 2 cohorts did not differ with respect to birth weight, sex, multiples, maternal age, or days of positive pressure respiratory support in the first 28 days (proxy for illness severity). Infants in the DM group had significantly fewer days of nasal cannula supplemental oxygen therapy compared with the pre-DM baseline (proxy for illness severity). Infants in the DM group received their first feed significantly earlier (42 hours) (Table 2) than those in the pre-DM period (52 hours), when including those infants who were fed in accordance with the feeding protocol (Table 1). Parental choices regarding diet for their infants are reflected by the number of infants exposed to each feeding
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Table 3. Dietary Exposures during the First 28 Days of Life for Very Low Birth Weight Infants before and after Establishment of Donor Milk Policy.
N Any formula, No. (%) Formula volume (first 28 d), median (25th, 75th percentiles) [range], mL/kg birth weightb Any mother’s milk, No. (%) Mother’s milk volume (first 28 d), median (25th, 75th percentiles) [range], mL/kg birth weightb Any donor milk, No. (%) Donor milk volume (first 28 d), median (25th, 75th percentiles) [range], mL/kg birth weightb Any human milk, No. (%) Human milk volume (first 28 d), median (25th, 75th percentiles) [range], mL/kg birth weightb Both mother’s milk and donor milk, No. (%) Mother’s and donor milk volume (first 28 d), median (25th, 75th percentiles) [range], mL/kg birth weightb
Pre-DM
DM
P Valuea
32 18 (56) 81 (10, 853) [2-5340]
122 23 (19) 479 (41, 1857) [4-5013]
< .001 .49
27 (84) 1225 (743, 2010) [6-3840]
104 (85) 1108 (486, 1649) [1-4077]
.99 .43
4 (12) 660 (213, 1249) [127-1477]
38 (31) 778 (209, 1799) [3-3960]
.04 .82
29 (91) 1352 (706, 2022) [6-3840]
113 (93) 1349 (781, 2084) [1-4077]
.99 .80
2 (6) 1579 (1137, 2022) [1137-2022]
29 (24) 1973 (1349, 2939) [251-3970]
.03 .57
Abbreviation: DM, donor milk. a Chi-square with continuity correction, Fisher exact, or Mann–Whitney U. b Includes only infants receiving volume > 0.
option as shown in Table 3. In the pre-DM period, when DM was offered only rarely on a case-by-case basis, 56% of infants received formula at some time in the first 28 days of life. This decreased significantly in the DM period to 19%. No difference was detected between the 2 study periods with respect to any exposure to MOM or to human milk overall. There were significant increases in the proportion of infants exposed to any DM overall (DM, or MOM and DM in combination) and DM in combination with MOM (MOM and DM in combination). In the DM period, 7 (5.7%) infants’ parents (including a set of twins) refused DM. The twins’ father refused when the mother did not (parents married), so DM could not be given to those 2 babies, despite the mother’s consent. Infants whose parents refused DM received a mean of 66.9 ± 32.4% of their feedings as MOM (range, 28%-100%). Receipt of an exclusive diet of human milk (combination of MOM, DM, or both) was significantly increased over the course of this study (Figure 1). However, the proportion of infants who received exclusive feedings of MOM, donor milk, or formula did not significantly differ after the implementation of a DM policy (Figure 1). Figure 2 compares pre-DM and DM with respect to the proportion of diet received in the first 28 days as each feeding type. There was a statistically significant increase in the proportion of DM and human milk feedings in the DM period compared with pre-DM baseline, accompanied by a significant decrease in proportion of diet as formula. There was no significant change in the proportion of feedings that were MOM in the DM period compared to the pre-DM baseline.
In both pre-DM and DM, DM feeding was only a small proportion of total enteral intake, with MOM representing a much larger proportion in both study periods. As reported in Table 4, multivariate linear and logistic regression analyses performed to adjust for potential effects of cohort differences confirmed all results of the univariate analysis. Compared with the pre-DM baseline, infants in the DM cohort remained significantly less likely to receive any formula in the first 28 days of life and were more likely to receive any DM or be fed exclusively human milk, after adjusting for the effects of gestational age, maternal primigravid status, and days of nasal cannula supplemental oxygen therapy. Proportions of diet in the first 28 days as DM and as human milk were increased in the DM group in multivariate analysis, whereas the proportion as formula was decreased compared to the pre-DM baseline. In addition, infants in the DM group were significantly less likely to be fed exclusively formula in the first 28 days, after adjusting for gestational age, primigravid status, and nasal cannula days.
Discussion This single-center prospective pre–post observational study found that introduction of a DM policy for VLBW infants to supplement MOM when needed was associated with a significant increase in proportion of infants fed a diet of exclusively human milk, with increased proportions of their diet as DM and as human milk. This was accompanied by no change in exposure to any MOM, proportion of infants fed
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Marinelli et al Figure 1. Proportion of Very Low Birth Weight Infants Receiving Exclusively Mother’s Milk, Donor Milk, Human Milk, or Formula in the First 28 Days of Life before (pre-DM) and after (DM) Establishment of Donor Milk Program.
Table 4. Results of Multivariate Regression Analyses Adjusted for Gestational Age, Maternal Primigravid Status, and Days Nasal Cannula Supplemental Oxygen in the First 28 Days of Life.a Outcome
DM vs Pre-DM b
Received any donor milk Received any mother’s milkb Received any human milkb Received any formulab Received exclusively donor milkb Received exclusively mother’s milkb Received exclusively human milkb Received exclusively formulab Proportion of diet as donor milke Proportion of diet as mother’s milke Proportion of diet as human milke Proportion of diet as formulae
Figure 2. Proportion of Diet as Mother’s Milk, Donor Milk, Human Milk, and Formula for Very Low Birth Weight Infants in the First 28 Days of Life before (pre-DM) and after (DM) Establishment of Donor Milk Program.
Proportion of Diet in Each Category Comparing between the Pre Donor Milk and Donor Milk Periods
exclusively MOM, or proportion of diet as MOM. In addition, there were significant reductions in exposure to any formula and proportion of diet as formula. We also observed a significantly earlier initiation of enteral feeding for these infants. These effects on the diet of the VLBW infant of introducing a DM policy in the first 28 days of life in a NICU have not previously been reported. Infants fed a diet of human milk versus preterm formula have improved feeding tolerance,19,29,30 lower incidences of late onset sepsis and other infections,2-5,30 and lower incidence and severity of retinopathy of prematurity.9-12 An
3.70 (1.13-12.07)c 1.54 (0.46-5.14) 3.01 (0.59-15.32) 0.07 (0.02-0.22)d 2.33 (0.24-22.32) 2.33 (0.96-5.65) 9.83 (3.44-28.06)d 1.15 (0.22-5.92) 0.15 (0.00-0.30)c 0.04 (–0.15 to 0.22) 0.19 (0.06-0.32)f –0.22 (–0.34 to –0.11)d
Abbreviations: CI, confidence interval; DM, donor milk; OR, odds ratio. a Outcomes are dietary exposures during the first 28 days. b Results given as OR (95% CI), adjusted for gestational age, primigravid status (Y/N), and days nasal cannula oxygen therapy, logistic regression model. c P < .05. d P < .001. e Results given as coefficient (95% CI), linear regression model. f P < .01.
entirely human milk diet provides the best protection against NEC in this population.16,17 In 1 study, VLBW infants fed an exclusive human milk diet (a combination of MOM, DM, and human milk-derived human milk fortifier when fortification was appropriate) had a 50% reduction in the rate of medical NEC and a 90% reduction in surgical NEC.17 Long-term benefits include improved neurodevelopmental outcomes, bone mass, lipoprotein profiles, cardiovascular health, and potentially decreased risk for obesity as well as all the benefits that accrue to term breastfed newborns.6,7,13-15,18,19,31-33 Our results suggest that providing DM through implementation of a formal policy to supplement MOM is associated with lower exposure to formula and promotes a diet of exclusively human milk. Further research is needed to document whether this is also associated with improved clinical outcomes for VLBW infants. Concerns were expressed prior to the policy implementation that mothers might be less motivated to express milk for their infants if DM were available. Reassuringly, no decrease in use of MOM was observed. A recently published study of the first 14 days of life of VLBW infants in 2 institutions with DM available also showed no decrease in MOM use.34 Over the 5 years of their study, Delfosse and colleagues’ parental consent refusal rate changed from 23% to 3%; ours was 5.7% for the 2 years combined. In addition, provision of MOM was higher in the privately insured, whereas DM and formula use were higher in the Medicaid-insured in that study. We did not find any sociodemographic differences between pre- and post-DM groups. Delfosse et al34 also reported that DM was
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significantly less likely to be given if mothers ever gave their own milk, whereas we found that 24% of our mothers in the DM period gave both MOM and DM (Table 3). Important differences in the respective DM protocols may have affected these results: Delfosse et al34 transitioned infants to formula at 14 days if MOM was not available or, in some instances, if infants on a combination of DM and MOM feeds received more DM than MOM, whereas in our protocol all infants receiving DM continued to receive it as needed for 10 weeks or until on 50% oral feeds, whichever occurred first. Staff adaptation to the routine use of DM occurred without great difficulty. We had been using DM sporadically, although not frequently, and had had a DM policy for its use in place, so its use was not totally unknown. In the 6-month wash-out period between baseline data collection and initiation of the DM policy, we had developed an educational presentation for the NICU faculty and senior staff. This included a literature review of the positive outcomes in the preterm population of human milk versus cow-milk-based preterm formulas, the existing data on the effects of the use of donor human milk and the differences between MOM, pasteurized human milk, and bovine-milk-based formula, and the results of our baseline data on the dietary composition of our VLBW babies. We developed the new policy for DM, taking into account maintaining a constant supply of DM in the unit, and procedures for handling the process (from calculating need, ordering, processing transport of the milk from delivery to the hospital to the NICU, recording the bottles received, storing in our freezer, and distributing and documenting lot numbers to individual infants). We also developed an informed consent specific to the use of DM. Once the hospital administration agreed to cover the cost of the DM, increasing in fact our original “ask” of all infants ≤ 1500 grams to all infants ≤ 1800 grams, we purchased a dedicated DM freezer. We immediately began an intensive in-servicing process of all NICU staff and simultaneously prepared information for educating parents. In addition to the relative ease of initiating this policy, we adopted a process of using a single bottle of DM (which could be either 3 or 4 ounces) for multiple infants. We employ clean technique to enter bottles of DM, and once bottles are defrosted and open, we use them for more than 1 recipient infant at a time, thereby minimizing the inevitable wastage that otherwise ensues when VLBW infants are on such small quantities of enteral feeds.
document a significant decrease in the proportion of infants receiving formula, we would have needed 388 infants per group. This would have required about 13 years of data collection in our institution, suggesting the need for a multicenter study. Further study is also needed to determine whether these results generalize to other settings. Our NICU has a very high baseline rate of the use of MOM (85%) when compared to other NICUs35 and is even notably higher than the 79% reported in the Connecticut full-term aggregate population by the Centers for Disease Control and Prevention.36 This is unusual since NICU populations, with the barriers inherent to them, would be expected to have lower rates than their regional full-term populations. In addition, our low baseline rate of exclusive formula feeding and small sample size may have affected the power to detect differences between groups. Further research in a multicenter collaboration will allow examination for small but clinically important differences between groups. Our small sample size prohibited us from detecting any differences in relevant clinical outcomes such as rates of sepsis or NEC. This study was limited to the first 28 days of life, a time period chosen to encompass the expected initiation and advancement to full enteral feeds while minimizing patient loss to transfer or discharge home. Accordingly, we could not assess any effect on length of hospitalization.
Conclusion Implementing a DM policy was associated with significant changes in the VLBW diet. There was a significant decrease in formula exposure and a corresponding decreased proportion of enteral intake as formula. There was an increase in exposure to human milk, an increased proportion of enteral intake as human milk, and an increased proportion of infants fed exclusively human milk. There was no decrease in MOM exposure or MOM as a proportion of enteral intake. In addition, we observed a significantly earlier initiation of first enteral feeds in infants who have the opportunity to begin feeds on DM if MOM is not available compared to those infants where a DM policy is not in place. These results provide evidence that a DM policy for supplementation of MOM for VLBW infants is desirable to increase human milk intake, decrease formula exposure, and initiate enteral feeds with human milk earlier. Acknowledgments
Limitations Ours is a single-center study in a level 4 NICU, limited in that the design is an observational pre–post intervention with prospectively collected data on differences in outcomes between the 2 groups. Although collected prospectively, the primary use of these data was to support establishing a new DM program and to generate baseline data for future research. The pre–post design of this study reflects this, as does the lack of a prospective sample size calculation. To
The authors wish to thank the families and staff in the Connecticut Children’s Medical Center’s neonatal intensive care unit, without whom we could not have done this study. We also wish to thank Tracey Proulx, RN, IBCLC, and Donna Bielieki, RN, IBCLC, who care for our families and assisted in data collection.
Declaration of Conflicting Interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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Marinelli et al Funding The authors received no financial support for the research, authorship, and/or publication of this article.
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enterocolitis than a diet of human milk and bovine milk based products. J Pediatr. 2010;156(4):562-567. 18. 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. 19. Arslanoglu S, Ziegler EE, Moro GE; World Association of Perinatal Medicine Working Group on Nutrition. Donor human milk in preterm infant feeding: evidence and recommendations. J Perinat Med. 2010;38(4):347-351. 20. Landers S, Hartmann BT. Donor human milk banking and the emergence of milk sharing. Pediatr Clin North Am. 2013;60(1):247-260. 21. 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. 22. Furman L, Minich NM, Hack M. Breastfeeding of very low birth weight infants. J Hum Lact. 1998;14(1):29-34. 23. Furman L, Minich N, Hack M. Correlates of lactation in mothers of very low birth weight infants. Pediatrics. 2002;109(4):e57. 24. Killersreiter B, Grimmer I, Buhrer C, et al. Early cessation of breast milk feeding in very low birthweight infants. Early Hum Dev. 2001;60(3):193-205. 25. Powers NG, Bloom B, Peabody J, Clark R. Site of care influences breastmilk feedings at discharge. J Perinatol. 2003;23(1):10-13. 26. Henderson JJ, Hartmann PE, Newnham JP, Simmer K. Effect of preterm birth and antenatal corticosteroid treatment on lactogenesis II in women. Pediatrics. 2008;121(1):e92-e100. 27. Perrine CG, Scanlon KS. Prevalence of use of human milk in US advanced care neonatal units. Pediatrics. 2013;131(6): 1066-1071. 28. Mukhopadhyay K, Louis D, Mahajan R, Kumar P. Predictors of mortality and major morbidities in extremely low birth weight neonates. Indian Pediatr. 2013;50(12):1119-1123. 29. Cavell B. Gastric emptying in infants fed human milk or infant formula. Acta Paediatr Scand. 1981;70(5):639-641. 30. Uraizee F, Gross S. Improved feeding tolerance and reduced incidence of sepsis in sick very low birthweight infants fed maternal milk. Pediatr Res. 1989;25:298A. 31. Singhal S, Cole TJ, Lucas A. Early nutrition in preterm infants and later blood pressure: two cohorts after randomised trials. Lancet. 2001;357(9254):413-419. 32. Singhal A, Cole TJ, Fewtrell M, Lucas A. Breastmilk feeding and lipoprotein profile in adolescents born preterm: followup of a prospective randomised study. Lancet. 2004;363(9421):1571-1578. 33. Fewtrell MS. Breast-feeding and later risk of CVD and obesity: evidence from randomised trials. Proc Nutr Soc. 2011;70(4):472-477. 34. Delfosse NM, Ward L, Lagomarcino AJ, et al. Donor human milk largely replaces formula-feeding of preterm infants in two urban hospitals. J Perinatol. 2013;33(6):446-451. 35. Lee HC, Kurtin PS, Wight NE, et al. A quality improvement project to increase breast milk use in very low birth weight infants. Pediatrics. 2012;130(6):e1679-e1687. 36. Division of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention. Breastfeeding report card—United States 2012. http://www.cdc.gov/breastfeeding/ pdf/2012BreastfeedingReportCard.pdf. Accessed February 22, 2014.
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The Effect of a Donor Milk Policy on the Diet of Very Low Birth Weight Infants Kathleen A. Marinelli, Mary M. Lussier, Elizabeth Brownell, Victor C. Herson and James I. Hagadorn J Hum Lact published online 18 April 2014 DOI: 10.1177/0890334414530511 The online version of this article can be found at: http://jhl.sagepub.com/content/early/2014/04/18/0890334414530511
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research-article2014
JHLXXX10.1177/0890334414530511Journal of Human LactationMarinelli et al
Original Research
The Effect of a Donor Milk Policy on the Diet of Very Low Birth Weight Infants
Journal of Human Lactation 1–7 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0890334414530511 jhl.sagepub.com
Kathleen A. Marinelli, MD, IBCLC1,2,3, Mary M. Lussier, BSN, IBCLC1,2, Elizabeth Brownell, PhD, MA1,2,3, Victor C. Herson, MD1,2,3, and James I. Hagadorn, MD, MS1,2,3
Abstract Background: Use of donor milk (DM) to supplement mother’s own milk (MOM) in the neonatal intensive care unit (NICU) is steadily increasing based on health and developmental benefits to premature infants. A paucity of data exists documenting the effect of DM use on the diet of very low birth weight (VLBW) infants related to the implementation of a DM policy. Objective: This study aimed to compare VLBW enteral intake type in the first 28 days of life before versus after establishing a DM policy. Methods: This single-center pre–post prospective cohort study included all inborn infants ≤ 1500 grams in a level 4 NICU remaining hospitalized at 28 days and admitted either before (pre-DM period, October 2009–March 2010) or after (DM period, October 2010–September 2012) implementing a DM policy. The feeding protocol was unchanged in both periods. Collected data included maternal/infant demographics, infant clinical data, and daily volume of enteral intake as MOM, DM, and formula. The proportion of enteral feeds from these sources during the first 28 days of life was compared pre-DM versus DM. Results: Compared to pre-DM baseline, formula exposure was significantly decreased, and human milk exposure and proportion of diet as human milk increased. The proportion of infants fed exclusively human milk increased. Exposure to and proportion of diet as MOM was unchanged. Infants were fed earlier in the DM period. Conclusion: Establishment of a DM policy was associated with reduced exposure to formula, promoting an exclusively human milk diet, with earlier initiation of feeds and no decrease in use of MOM. Keywords breastfeeding, donor milk, human milk, nutrition, premature infant, very low birth weight infant
Well Established The protective effects of human milk for premature infants are well known. Although donor milk use in neonatal intensive care units is increasing, its effect on the diet of very low birth weight (VLBW) infants is largely unknown.
Newly Expressed Establishing a donor milk policy for VLBW infants is associated with reduced formula and increased human milk exposure, increased proportion of diet as human milk, and earlier start of enteral feeds with no decrease in the use of mother’s own milk observed.
may not be able to express colostrum in the first postpartum days or ultimately achieve an adequate supply for their infants for a number of well-recognized reasons, including initiating and maintaining expression with a mechanical pump, fatigue, stress, and maternal illness.20,22-26 As a result, use of donor milk (DM) as either a supplement to mother’s own milk (MOM) or an exclusive diet for infants who receive
1
The Connecticut Human Milk Research Center, Hartford, CT, USA Division of Neonatology, Connecticut Children’s Medical Center, Hartford, CT, USA 3 Department of Pediatrics, University of Connecticut School of Medicine, Farmington, CT, USA 2
Date submitted: June 3, 2013; Date accepted: March 13, 2014.
Background The health and developmental benefits of human milk for very low birth weight (VLBW, ≤ 1500 grams) infants are well documented.1-21 However, mothers of preterm infants
Corresponding Author: Kathleen A. Marinelli, MD, IBCLC, 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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no mother’s milk is increasing, as are the number of neonatal intensive care units (NICUs) implementing DM policies.27 Despite the recent increase in DM utilization, several aspects regarding the implementation of a DM policy in the NICU remain undocumented. A speculative concern has been voiced among neonatologists that introducing DM may discourage maternal efforts to produce their own milk. In addition, the effect of establishing a DM policy in a NICU on the VLBW diet over the first 28 days of life is still unexplored. The purpose of this study was to examine the association between the introduction of a DM policy for supplementation of MOM and the intake of human milk and formula over the first 28 days of life among VLBW infants.
Methods Sample This study was conducted in the Connecticut Children’s Medical Center’s 32-bed level 4 NICU in Hartford, Connecticut. The Connecticut Children’s Institutional Review Board determined this study to be exempt from oversight. Data were collected prospectively over 2 study periods. Baseline data were collected for 6 months (October 1, 2009– March 31, 2010) prior to adoption of the DM policy (preDM). A 6-month washout period followed, allowing for policy development and implementation, staff education, and acclimation. Data collection then resumed October 1, 2010 to September 30, 2012, the period when DM became the preferred alternative. All inborn infants with birth weight ≤ 1500 grams admitted during 1 of the 2 study periods and remaining hospitalized at 28 days of life were included in the study. Data recorded included maternal and infant demographics, volume and type (MOM, DM, formula, and total human milk) of enteral feeding per day, and hour of life of initiation of enteral feeding (calculated from the hour of birth and the documented time of first feed on a daily bedside recording sheet). Illness severity was compared between groups with positive pressure respiratory support and nasal cannula days as proxies for this comparison. All data were obtained from the infant’s written and electronic medical records and recorded on individual data collection sheets. Data abstractors were 3 NICU lactation consultants (LCs), all previously trained and employed as NICU registered nurses at Connecticut Children’s, or 1 neonatologist. One LC and the neonatologist did spot checks to evaluate the internal validity of the data.
Design On August 1, 2010, the Connecticut Children’s NICU officially adopted a policy of providing DM as the preferred alternative if MOM is not available in sufficient quantity to
meet her infant’s need. We use the term preferred alternative as opposed to standard of care as we require informed consent. Our NICU infants are eligible to receive DM if they are born ≤ 1800 grams or ≤ 32 weeks gestation. Per policy, all VLBW infants may receive DM for up to 10 weeks or until they achieve 50% of full oral feedings, whichever comes first. The study end-point of 28 days was chosen to avoid attrition due to transfer or discharge home. Prior to initiating the DM policy, all neonatologists and clinical staff were educated and remain well-versed in the DM policy and eligibility. Discussions of the importance of human milk for premature infants begin as soon as we meet the parents. This can be in a scheduled prenatal consult; on the high-risk antenatal in-patient unit; on labor and delivery if time allows prior to delivery; or on labor and delivery, in mother’s postpartum room, or at the infant’s bedside if delivery has occurred in emergent circumstances. We discuss the importance of MOM and of our commitment to helping each mother reach her potential in milk production unless there is a reason not to use her milk. We talk about human milk as being “medicine” for her infant, especially her colostrum, and educate on the importance of MOM for nutrition, immune function, and neurodevelopment specifically. We then inform the family of our DM policy, particularly that it is in support of our maternal breast milk/breastfeeding program. A standard feeding protocol had been introduced to this NICU prior to the DM policy (Table 1). That protocol was followed in both study periods and was not modified during the study. We discuss that it is common to need some DM at the very beginning when we start feedings within the first 48 hours after birth as per our feeding protocol (Table 1), when many mothers even using hand expression do not express enough milk to start feeds, and then again about a month out when infants often have advanced on feeds exceeding mother’s milk supply. Parental concerns are addressed by any of the clinical staff. Informed consent is obtained from parents by the attending neonatologists, nurse practitioners, physician assistants, or NICU lactation consultants. The incremental cost of the DM is covered by the hospital per diem charge and is not a separate reimbursable expense.
Statistical Analysis Categorical data from the DM period were compared to the pre-DM baseline using chi-square test with continuity correction. Fisher exact test was used for comparisons of categorical data where counts in individual cells were less than 5. Mann–Whitney U test was used for comparison of continuous data to avoid assumption of normal distribution. Multivariate logistic regression was used to examine the adjusted relationship between the study’s categorical dietary outcomes in DM as compared to pre-DM. Linear regression was used similarly to examine continuous outcomes. Variables were included in regression analyses based
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Marinelli et al Table 1. Connecticut Children’s Medical Center Feeding Protocol.a Initiation of Feeds
Amount
Route
Substrate
Advancement
Fortification
< 1000 g
By 48 h of life
10 mL/kg/d
Bolus divided Q6h
Human milk or preterm formula
Start at 100 mL/ kg/d enteral feeds
1000-1500 g
By 48 h of life
15 mL/kg/d
Bolus divided Q3h
Human milk or preterm formula
On day 4 ↑ to 20 mL/ kg/d for 3 d, divided Q 4 h; then ↑ by 1520 mL/kg/d Q 24 h, divided Q 3 h After 3 days, ↑ 15-20 mL/kg/d Q 24 h
Birth Weight
Start at 100 mL/ kg/d enteral feeds
Abbreviation: Q, every. a Feeds held for bloody stool; bilious emesis; abdominal distention; cardiovascular instability, ie, acidosis or hypotension requiring medications; significant apnea and bradycardia; hemodynamically significant patent ductus arteriosis (PDA) requiring use of medications. Practitioner notified if aspirate obtained Q 6 hours is > 50% of previous 6-hour volume delivered.
Table 2. Study Cohort Demographics. Pre-DM N Maternal age, median (25th, 75th percentiles), y Primigravid mother, No. (%) Birth weight, median (25th, 75th percentiles), g Gestational age, median (25th, 75th percentiles), wk Multiples, No. (%) Female, No. (%) Insurance, No. (%) Private State Race/ethnicity, No. (%) White Black Hispanic Other Ventilator days (first 28 d), median (25th, 75th percentiles) CPAP days (first 28 d), median (25th, 75th percentiles) Days on nasal cannula (first 28 d), median (25th, 75th percentiles) Hours to first feed, median (25th, 75th percentiles)b
32 30 (25.3, 33.0) 5 (15.6) 900 (771, 1216) 26.6 (25.5, 29.0) 12 (37.5) 20 (62.5) 19 (59.4) 13 (40.6)
DM
P Valuea
122 29 (23.8, 33.0) 44 (36.1) 1115 (860, 1290) 29.0 (27.0, 31.1) 31 (25.4) 68 (55.7)
.310 .030 .100 .001 .256 .550 .233 .142 .110 .750 .040 .017
56 (49.5) 56 (49.5)
19 (59.4) 46 (37.7) 7 (21.9) 34 (27.9) 4 (12.5) 33 (27.0) 2 (6.3) 9 (7.3) 2.5 (1.0, 17.5) 2.0 (0.0, 8.0) 7.5 (6.0, 19.0) 8.0 (2.0, 20.0) 0 (0.0, 5.5) 0 (0.0, 0.0) 52 (42.5, 61.3) (N = 26) 42 (31.0, 52.0) (N = 88)
Abbreviations: CPAP, continuous positive airway pressure; DM, donor milk. a Chi-square with continuity correction, Fisher exact, or Mann–Whitney U. b Infants excluded whose feeds were held appropriately according to feeding protocol (see Table 1).
on previous research demonstrating possible association (necrotizing enterocolitis [NEC], birth weight, days on continuous positive airway pressure in the first 28 days of life, days on ventilator in the first 28 days of life, sex, and time to first feed)12,17,18,25,28 or if they were significant in univariate analysis (gestational age, maternal primigravid status, and days of nasal cannula oxygen in the first 28 days of life.). All tests were 2-sided, with P < .05 considered statistically significant.
Results There were 32 infants in the 6-month pre-DM group and 122 in the 24-month DM group (Table 2). Mothers in the pre-DM
group were significantly less likely to be primigravid, and their infants were significantly more premature than the DM group. The 2 cohorts did not differ with respect to birth weight, sex, multiples, maternal age, or days of positive pressure respiratory support in the first 28 days (proxy for illness severity). Infants in the DM group had significantly fewer days of nasal cannula supplemental oxygen therapy compared with the pre-DM baseline (proxy for illness severity). Infants in the DM group received their first feed significantly earlier (42 hours) (Table 2) than those in the pre-DM period (52 hours), when including those infants who were fed in accordance with the feeding protocol (Table 1). Parental choices regarding diet for their infants are reflected by the number of infants exposed to each feeding
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Table 3. Dietary Exposures during the First 28 Days of Life for Very Low Birth Weight Infants before and after Establishment of Donor Milk Policy.
N Any formula, No. (%) Formula volume (first 28 d), median (25th, 75th percentiles) [range], mL/kg birth weightb Any mother’s milk, No. (%) Mother’s milk volume (first 28 d), median (25th, 75th percentiles) [range], mL/kg birth weightb Any donor milk, No. (%) Donor milk volume (first 28 d), median (25th, 75th percentiles) [range], mL/kg birth weightb Any human milk, No. (%) Human milk volume (first 28 d), median (25th, 75th percentiles) [range], mL/kg birth weightb Both mother’s milk and donor milk, No. (%) Mother’s and donor milk volume (first 28 d), median (25th, 75th percentiles) [range], mL/kg birth weightb
Pre-DM
DM
P Valuea
32 18 (56) 81 (10, 853) [2-5340]
122 23 (19) 479 (41, 1857) [4-5013]
< .001 .49
27 (84) 1225 (743, 2010) [6-3840]
104 (85) 1108 (486, 1649) [1-4077]
.99 .43
4 (12) 660 (213, 1249) [127-1477]
38 (31) 778 (209, 1799) [3-3960]
.04 .82
29 (91) 1352 (706, 2022) [6-3840]
113 (93) 1349 (781, 2084) [1-4077]
.99 .80
2 (6) 1579 (1137, 2022) [1137-2022]
29 (24) 1973 (1349, 2939) [251-3970]
.03 .57
Abbreviation: DM, donor milk. a Chi-square with continuity correction, Fisher exact, or Mann–Whitney U. b Includes only infants receiving volume > 0.
option as shown in Table 3. In the pre-DM period, when DM was offered only rarely on a case-by-case basis, 56% of infants received formula at some time in the first 28 days of life. This decreased significantly in the DM period to 19%. No difference was detected between the 2 study periods with respect to any exposure to MOM or to human milk overall. There were significant increases in the proportion of infants exposed to any DM overall (DM, or MOM and DM in combination) and DM in combination with MOM (MOM and DM in combination). In the DM period, 7 (5.7%) infants’ parents (including a set of twins) refused DM. The twins’ father refused when the mother did not (parents married), so DM could not be given to those 2 babies, despite the mother’s consent. Infants whose parents refused DM received a mean of 66.9 ± 32.4% of their feedings as MOM (range, 28%-100%). Receipt of an exclusive diet of human milk (combination of MOM, DM, or both) was significantly increased over the course of this study (Figure 1). However, the proportion of infants who received exclusive feedings of MOM, donor milk, or formula did not significantly differ after the implementation of a DM policy (Figure 1). Figure 2 compares pre-DM and DM with respect to the proportion of diet received in the first 28 days as each feeding type. There was a statistically significant increase in the proportion of DM and human milk feedings in the DM period compared with pre-DM baseline, accompanied by a significant decrease in proportion of diet as formula. There was no significant change in the proportion of feedings that were MOM in the DM period compared to the pre-DM baseline.
In both pre-DM and DM, DM feeding was only a small proportion of total enteral intake, with MOM representing a much larger proportion in both study periods. As reported in Table 4, multivariate linear and logistic regression analyses performed to adjust for potential effects of cohort differences confirmed all results of the univariate analysis. Compared with the pre-DM baseline, infants in the DM cohort remained significantly less likely to receive any formula in the first 28 days of life and were more likely to receive any DM or be fed exclusively human milk, after adjusting for the effects of gestational age, maternal primigravid status, and days of nasal cannula supplemental oxygen therapy. Proportions of diet in the first 28 days as DM and as human milk were increased in the DM group in multivariate analysis, whereas the proportion as formula was decreased compared to the pre-DM baseline. In addition, infants in the DM group were significantly less likely to be fed exclusively formula in the first 28 days, after adjusting for gestational age, primigravid status, and nasal cannula days.
Discussion This single-center prospective pre–post observational study found that introduction of a DM policy for VLBW infants to supplement MOM when needed was associated with a significant increase in proportion of infants fed a diet of exclusively human milk, with increased proportions of their diet as DM and as human milk. This was accompanied by no change in exposure to any MOM, proportion of infants fed
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Marinelli et al Figure 1. Proportion of Very Low Birth Weight Infants Receiving Exclusively Mother’s Milk, Donor Milk, Human Milk, or Formula in the First 28 Days of Life before (pre-DM) and after (DM) Establishment of Donor Milk Program.
Table 4. Results of Multivariate Regression Analyses Adjusted for Gestational Age, Maternal Primigravid Status, and Days Nasal Cannula Supplemental Oxygen in the First 28 Days of Life.a Outcome
DM vs Pre-DM b
Received any donor milk Received any mother’s milkb Received any human milkb Received any formulab Received exclusively donor milkb Received exclusively mother’s milkb Received exclusively human milkb Received exclusively formulab Proportion of diet as donor milke Proportion of diet as mother’s milke Proportion of diet as human milke Proportion of diet as formulae
Figure 2. Proportion of Diet as Mother’s Milk, Donor Milk, Human Milk, and Formula for Very Low Birth Weight Infants in the First 28 Days of Life before (pre-DM) and after (DM) Establishment of Donor Milk Program.
Proportion of Diet in Each Category Comparing between the Pre Donor Milk and Donor Milk Periods
exclusively MOM, or proportion of diet as MOM. In addition, there were significant reductions in exposure to any formula and proportion of diet as formula. We also observed a significantly earlier initiation of enteral feeding for these infants. These effects on the diet of the VLBW infant of introducing a DM policy in the first 28 days of life in a NICU have not previously been reported. Infants fed a diet of human milk versus preterm formula have improved feeding tolerance,19,29,30 lower incidences of late onset sepsis and other infections,2-5,30 and lower incidence and severity of retinopathy of prematurity.9-12 An
3.70 (1.13-12.07)c 1.54 (0.46-5.14) 3.01 (0.59-15.32) 0.07 (0.02-0.22)d 2.33 (0.24-22.32) 2.33 (0.96-5.65) 9.83 (3.44-28.06)d 1.15 (0.22-5.92) 0.15 (0.00-0.30)c 0.04 (–0.15 to 0.22) 0.19 (0.06-0.32)f –0.22 (–0.34 to –0.11)d
Abbreviations: CI, confidence interval; DM, donor milk; OR, odds ratio. a Outcomes are dietary exposures during the first 28 days. b Results given as OR (95% CI), adjusted for gestational age, primigravid status (Y/N), and days nasal cannula oxygen therapy, logistic regression model. c P < .05. d P < .001. e Results given as coefficient (95% CI), linear regression model. f P < .01.
entirely human milk diet provides the best protection against NEC in this population.16,17 In 1 study, VLBW infants fed an exclusive human milk diet (a combination of MOM, DM, and human milk-derived human milk fortifier when fortification was appropriate) had a 50% reduction in the rate of medical NEC and a 90% reduction in surgical NEC.17 Long-term benefits include improved neurodevelopmental outcomes, bone mass, lipoprotein profiles, cardiovascular health, and potentially decreased risk for obesity as well as all the benefits that accrue to term breastfed newborns.6,7,13-15,18,19,31-33 Our results suggest that providing DM through implementation of a formal policy to supplement MOM is associated with lower exposure to formula and promotes a diet of exclusively human milk. Further research is needed to document whether this is also associated with improved clinical outcomes for VLBW infants. Concerns were expressed prior to the policy implementation that mothers might be less motivated to express milk for their infants if DM were available. Reassuringly, no decrease in use of MOM was observed. A recently published study of the first 14 days of life of VLBW infants in 2 institutions with DM available also showed no decrease in MOM use.34 Over the 5 years of their study, Delfosse and colleagues’ parental consent refusal rate changed from 23% to 3%; ours was 5.7% for the 2 years combined. In addition, provision of MOM was higher in the privately insured, whereas DM and formula use were higher in the Medicaid-insured in that study. We did not find any sociodemographic differences between pre- and post-DM groups. Delfosse et al34 also reported that DM was
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Journal of Human Lactation
significantly less likely to be given if mothers ever gave their own milk, whereas we found that 24% of our mothers in the DM period gave both MOM and DM (Table 3). Important differences in the respective DM protocols may have affected these results: Delfosse et al34 transitioned infants to formula at 14 days if MOM was not available or, in some instances, if infants on a combination of DM and MOM feeds received more DM than MOM, whereas in our protocol all infants receiving DM continued to receive it as needed for 10 weeks or until on 50% oral feeds, whichever occurred first. Staff adaptation to the routine use of DM occurred without great difficulty. We had been using DM sporadically, although not frequently, and had had a DM policy for its use in place, so its use was not totally unknown. In the 6-month wash-out period between baseline data collection and initiation of the DM policy, we had developed an educational presentation for the NICU faculty and senior staff. This included a literature review of the positive outcomes in the preterm population of human milk versus cow-milk-based preterm formulas, the existing data on the effects of the use of donor human milk and the differences between MOM, pasteurized human milk, and bovine-milk-based formula, and the results of our baseline data on the dietary composition of our VLBW babies. We developed the new policy for DM, taking into account maintaining a constant supply of DM in the unit, and procedures for handling the process (from calculating need, ordering, processing transport of the milk from delivery to the hospital to the NICU, recording the bottles received, storing in our freezer, and distributing and documenting lot numbers to individual infants). We also developed an informed consent specific to the use of DM. Once the hospital administration agreed to cover the cost of the DM, increasing in fact our original “ask” of all infants ≤ 1500 grams to all infants ≤ 1800 grams, we purchased a dedicated DM freezer. We immediately began an intensive in-servicing process of all NICU staff and simultaneously prepared information for educating parents. In addition to the relative ease of initiating this policy, we adopted a process of using a single bottle of DM (which could be either 3 or 4 ounces) for multiple infants. We employ clean technique to enter bottles of DM, and once bottles are defrosted and open, we use them for more than 1 recipient infant at a time, thereby minimizing the inevitable wastage that otherwise ensues when VLBW infants are on such small quantities of enteral feeds.
document a significant decrease in the proportion of infants receiving formula, we would have needed 388 infants per group. This would have required about 13 years of data collection in our institution, suggesting the need for a multicenter study. Further study is also needed to determine whether these results generalize to other settings. Our NICU has a very high baseline rate of the use of MOM (85%) when compared to other NICUs35 and is even notably higher than the 79% reported in the Connecticut full-term aggregate population by the Centers for Disease Control and Prevention.36 This is unusual since NICU populations, with the barriers inherent to them, would be expected to have lower rates than their regional full-term populations. In addition, our low baseline rate of exclusive formula feeding and small sample size may have affected the power to detect differences between groups. Further research in a multicenter collaboration will allow examination for small but clinically important differences between groups. Our small sample size prohibited us from detecting any differences in relevant clinical outcomes such as rates of sepsis or NEC. This study was limited to the first 28 days of life, a time period chosen to encompass the expected initiation and advancement to full enteral feeds while minimizing patient loss to transfer or discharge home. Accordingly, we could not assess any effect on length of hospitalization.
Conclusion Implementing a DM policy was associated with significant changes in the VLBW diet. There was a significant decrease in formula exposure and a corresponding decreased proportion of enteral intake as formula. There was an increase in exposure to human milk, an increased proportion of enteral intake as human milk, and an increased proportion of infants fed exclusively human milk. There was no decrease in MOM exposure or MOM as a proportion of enteral intake. In addition, we observed a significantly earlier initiation of first enteral feeds in infants who have the opportunity to begin feeds on DM if MOM is not available compared to those infants where a DM policy is not in place. These results provide evidence that a DM policy for supplementation of MOM for VLBW infants is desirable to increase human milk intake, decrease formula exposure, and initiate enteral feeds with human milk earlier. Acknowledgments
Limitations Ours is a single-center study in a level 4 NICU, limited in that the design is an observational pre–post intervention with prospectively collected data on differences in outcomes between the 2 groups. Although collected prospectively, the primary use of these data was to support establishing a new DM program and to generate baseline data for future research. The pre–post design of this study reflects this, as does the lack of a prospective sample size calculation. To
The authors wish to thank the families and staff in the Connecticut Children’s Medical Center’s neonatal intensive care unit, without whom we could not have done this study. We also wish to thank Tracey Proulx, RN, IBCLC, and Donna Bielieki, RN, IBCLC, who care for our families and assisted in data collection.
Declaration of Conflicting Interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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Marinelli et al Funding The authors received no financial support for the research, authorship, and/or publication of this article.
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