Fortification of Maternal Expressed Breast Milk
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1 Fortification of Maternal Expressed Breast Milk Title: Version: 2 Ratification Date: April 2016 Review Date: April 2019 Approval: Nottingham Neonatal Service Clinical Guideline Group 20 th April 2016 Author: Chris Jarvis Job Title: Specialist Neonatal Dietitian Consultation: Dr Shalini Ojha, Consultant Neonatologist; Nottingham Neonatal Service Staff and Clinical Guideline Meeting Guideline Contact Chris Jarvis, Specialist Neonatal Dietitian c/o Stephanie Tyrrell, Nottingham Neonatal Service stephanie.tyrrell@nuh.nhs.uk Distribution: Nottingham Neonatal Service, Neonatal Intensive Care Units Target audience: Staff of the Nottingham Neonatal Service Patients to whom Patients of the Nottingham Neonatal Service who fit the inclusion criteria of this applies: the guideline below Key Words: Expressed breast milk, breast milk fortifier Risk Managed: Optimum Nutrition for the Breastfed Preterm Infant Evidence used: The contemporary evidence base has been used to develop this guideline. References to studies utilised in the preparation of this guideline are given at its end. Clinical guidelines are guidelines only. The interpretation and application of clinical guidelines remain the responsibility of the individual clinician. If in doubt, contact a senior colleague. Caution is advised when using guidelines after the review date. This guideline has been registered with the Nottingham University Hospitals NHS Trust. 1 Introduction/background Expressed breast milk (EBM) from mothers who give birth prematurely initially has higher levels of some nutrients such as protein, fat, energy and sodium which is in part explained by lower volumes [1, 2]. Studies show that nutrients, particularly protein levels, fall resulting in a nutritional profile that is inadequate to meet the extremely high requirements of the preterm infant. Recommended nutrient intakes for infants born prematurely are not met by a proportional increase in all nutrients [3, 4] so giving higher volumes of EBM, even if tolerated, will not achieve these theoretical requirements. It is now widely accepted that ELBW preterm infants will need to receive supplementation of most nutrients [5], especially protein [6]. Multi-nutrient fortifiers have been developed to fortify breast milk for preterm infants to preserve the known benefits of maternal breast milk while optimising nutritional status and growth. Most studies have found no significant problems with tolerance of fortified EBM, [7, 8] gastric emptying [9-12] or risk of bacterial contamination.[13-15] Increased osmolality due to hydrolysis of maltodextrin in BMF by human milk amylase has been shown [16]. This can be reduced by adding BMF immediately prior to feeding where possible, though the clinical significance of osmolality within the ranges seen is probably not relevant [17]. A Cochrane review concludes that there are short-term improvements in weight, length and head circumference due to use of multi nutrient breast milk fortifiers and that further comparative study with breast milk alone is unlikely to be performed [18]. It directs further research to evaluation of longer term outcomes and towards the optimum composition [19, 20]. Breast milk is fortified without knowing the composition of an individual mother s EBM and whilst analysis of all nutrients in EBM before addition of fortifier would be impractical bedside analysers are available to estimated protein, fat, lactose and energy. Protein has long been recognised as the major limiting nutrient [21, 22] and a recent study has shown protein concentration is still significantly lower than expected even with addition of BMF, and that inadequate protein intakes are associated with poor growth [23]. However, routine measurement of EBM is not currently common practice.
2 The use of serum urea has been validated as an indicator of protein adequacy in preterm infants. [24, 25] Comparing addition of a standard amount of breast milk fortifier to a variable amount determined by regular measurement of serum urea, showed significant improvement in both weight and head circumference [26] reinforcing the view that higher protein was primarily responsible for the improved growth. Only two commercial multinutrient breast milk fortifiers (BMFs) are available in the UK Nutriprem BMF (Cow & Gate) and SMA BMF (Nestlé). Both are sachets of powder based on cow s milk protein. Neither come with clear recommendations for use so exactly which babies might benefit from their use or when they should be commenced is unknown, leading to considerable variation in practice [27]. Fortification of EBM using concentrated human milk as a fortifier for EBM has been studied for many years in Scandinavia and more recently in the US [28]. Commercially produced liquids using concentrated human milk are available in the US as fortifiers to be added to maternal EBM or as human milk based premature formulas to use when no EBM is available. There is currently no human milk based fortifier or formula in the UK. 2 Patient group/indications Addition of BMF to EBM should be considered for the following infants once they are established on and tolerating 150ml/kg EBM for hours: Infants born weighing <1.5kg Infants born weighing >1.5kg but <2kg where birth weight for gestational age <9th centile or Volumes of ml/kg EBM are not likely to be tolerated or Weight gain is poor on maximum volume tolerated or Serum urea falls <2 micromol/l or is steadily falling In general it is better to add BMF at 150ml/kg/day rather than continue to increase volume of EBM. Addition of BMF at 150ml/kg/day will provide 1.8g protein, 24kcal extra as well as 1.8mmol/kg/day of phosphate, whereas an increase to 180ml/kg EBM is likely to provide a maximum of 0.5g protein, 20kcal and 0.2mmol phosphate/kg/day. However, adding BMF once a baby has reached 180ml/kg/day EBM may provide too much nutrition and risks feed intolerance. BMF is added during the period where EBM is used and fed via tube until transition to feeding from the breast. This provides a means of making up some of the nutritional deficit without interfering with our aim to establish full breast feeding. Within the above recommendations, BMF may be withheld if, for example, an infant who has not experienced intrauterine growth retardation is sufficiently developmentally mature to achieve full breast feeding within approximately 2 weeks. Conversely, infants born >34w or weighing >2kg who have been significantly unwell in the newborn period or have a substantial cumulative nutrient deficit due to difficulties giving adequate nutrition in the first few weeks after birth, may occasionally benefit from BMF. This should be discussed with the attending consultant and neonatal dietitian as it may not be the best solution. 2
3 3 Management 3.1 Which product to use? The two products available in the UK Nutriprem BMF and SMA BMF are similar in nutritional composition. There is no good evidence to support use of one product over the other. Neither provides adequate protein to meet the increased needs of the preterm infant either as recommended [29] or as studied [23]. Nutriprem BMF has been chosen because the protein source is hydrolysed whey and casein which may be beneficial in those infants where parents prefer not to use cow s milk protein as hydrolysed protein may be less allergenic than a whole protein. Nutriprem BMF is available in 2.2g sachets to be added to 50ml EBM (Section 7: Appendix 1). 3.2 When to start? Breast milk fortifier should be prescribed prior to use and added to EBM once tolerated at 150ml/kg/day for hours. Fresh EBM should always be used where supply is adequate with frozen milk only if insufficient fresh milk. Exception to this is EBM expressed in the first week which should usually be used in date order to ensure baby receives colostrum. When reintroducing feeds in a baby who has previously tolerated full feeds of EBM + BMF, it is possible to establish feeding again using fortified EBM. Babies following NEC may be an exception so discuss with the neonatal consultant and surgeon. It may not be necessary to add BMF if more than half of feed requirement is provided by preterm formula. However, individual reasons for continuing to add BMF include poor growth or poor tolerance of volume. In practice this would depend on having adequate volumes of milk. BMF must never be added to formula as a supplement, but it is safe to mix formula with EBM that has been already been fortified. 3.3 Addition of BMF 1. Aseptic practices should be used as for all feed preparation using purple trays provided. While acknowledging addition of a non-sterile powder to EBM is not in line with Department of Health guidance on feed preparation, the practice below offers a pragmatic alternative until a sterile preparation is available 2. BMF should be added as close to feeding as possible and stored in the fridge until required for a feed. Fortified EBM should be used immediately if possible but may be stored in a fridge (2-4 C) for a maximum of 6 hours 3. Only the amount required for a feed should be brought to room temperature, the remainder returned immediately to the fridge 4. 1 sachet (2.2g) of Nutriprem BMF should be added to 50ml EBM 5. When <50ml EBM is available a clean 2.5ml scoop can be used for addition of ~½ sachet to 25ml EBM according to specific instructions. (Section 7: Appendix 1) 6. After addition EBM + BMF should be gently shaken as per manufacturer instructions 3.4 Monitoring No additional biochemical monitoring is required because of using BMF. If it is continued in more mature infants where regular monitoring of urea, electrolytes and bone minerals would normally cease, it is advisable to continue weekly monitoring until BMF is stopped. Preterm infants between 1.5-2kg at birth, who are growing well on unfortified EBM, may show biochemical signs of sodium and phosphorus deficiency. Regular routine monitoring will identify those requiring supplements. Serum calcium should ideally be maintained between mmol/l and phosphate mmol/l with serum Ca higher than phosphate 3
4 3.5 When to stop? For most babies, the decision to stop EBM fortification will be led by the infant s establishment of breast feeding. In general fortification of EBM should never hinder the establishment of full breast feeding. As the baby becomes ready for oral feeds, a staged transfer towards full breastfeeding should be individually planned. The opportunity to fortify breast milk is therefore reduced as feeding from the breast replaces gastric tube feeding, and the baby is demand feeding rather than having feeds externally controlled. If there is insufficient EBM and a preterm formula is being used, it is unlikely that BMF will be required once EBM is providing <50% of feed requirements, so it can probably be stopped. In infants who have significant growth deficits it may be advisable to continue if practical. Discuss with attending consultant or neonatal dietitian. Studies show developmental advantages in preterm infants who are fed their own mother s milk [30] and accelerated catch-up growth may not be beneficial [31]. Therefore, although the nutritional profile of breast milk may not be ideal for the catch up growth often required of the preterm infant, the benefits probably outweigh those of nutrient enriched post discharge formulas. Nevertheless, should any supplementary feed be required in a breast fed infant born less than 34 weeks, weighing less than 2kg, the family should be advised that a nutrient enriched postdischarge formula, such as Nutriprem 2, offers advantages over a standard term formula and should request a supply from their GP. It is prescribable for these infants up until a maximum of 6 months corrected age and should be stopped by this time or before if weight gain is excessive. 4 Audit Points 4.1 Routine data collection Number of babies who do not receive BMF who should do within the guideline 4.2 Specific audit points Number of babies 1.5-2kg who receive on BMF due to poor growth, low serum urea or poor tolerance of volume required for growth 5 Allied Guidelines D3 Introducing and Advancing Enteral Feeds D4 Enteral Feeding D5 Vitamin Supplementation D6 Neonatal Parenteral Nutrition D8 Iron Supplementation D10 Feeding Babies with Neonatal Surgical Problems D14 Growth Monitoring on the Neonatal Unit 4
5 6 Bibliography 1. Anderson, D., et al., Length of gestation and nutritional composition of human milk. American Journal of Clinical Nutrition, (5): p Lucas, A. and G. Hudson, Preterm milk as a source of protein for low birthweight infants. Archives of Disease in Childhood, (9): p ESPGHAN, et al., Enteral nutrient supply for preterm infants. Journal of Pediatric Gastroenterology & Nutrition, : p Koletzko, B., B. Poindexter, and R. Uauy, eds. Nutritional Care of Preterm Infants: Scientific Basis and Practical Guidelines. Vol , Karger. 5. WHO, Acceptable Medical Reasons for the Use of Breast-Milk Substitutes Ziegler, E.E., Human milk and human milk fortifiers, in Nutritional Care of Preterm Infants: Scientific Basis and Practical Guidleines B. Koletzko, B. Poindexter, and R. Uauy, Editors. 2014, Karger. p Lucas, A., et al., Randomized outcome trial of human milk fortification and developmental outcome in preterm infants. American Journal of Clinical Nutrition, (2): p Moody, G.J., et al., Feeding tolerance in premature infants fed fortified human milk. Journal of Pediatric Gastroenterology & Nutrition., (4): p Ewer, A.K. and V.Y. Yu, Gastric emptying in pre-term infants: the effect of breast milk fortifier. Acta Paediatrica, (9): p McClure, R.J. and S.J. Newell, Effect of fortifying breast milk on gastric emptying. Archives of Disease in Childhood Fetal & Neonatal Edition, (1): p. F Perrella, S.L., et al., Influences of breast milk composition on gastric emptying in preterm infants. Journal of Pediatric Gastroenterology and Nutrition, (2): p Yigit, S., et al., Breast milk fortification: effect on gastric emptying. Journal of Maternal-Fetal & Neonatal Medicine, (11): p Quan, R., et al., The effect of nutritional additives on anti-infective factors in human milk. Clinical Pediatrics, (6): p Jocson, M., E. Mason, and R. Schanler, The effects of nutrient fortification and varying storage conditions on host defense properties of human milk. Pediatrics, (2): p Telang, S., et al., Fortifying fresh human milk with commercial powdered human milk fortifiers does not affect bacterial growth during 6 hours at room temperature. Journal of the American Dietetic Association, (10): p De Curtis, M., et al., Effect of fortification on the osmolality of human milk. Archives of Disease in Childhood Fetal & Neonatal Edition, (2): p. F Pearson, F., M.J. Johnson, and A.A. Leaf, Milk osmolality: does it matter? Archives of Disease in Childhood Fetal & Neonatal Edition, (2): p. F Kuschel, C. and J. Harding, Multicomponent fortified human milk for promoting growth in preterm infants. Cochrane Database of Systematic Reviews, 2004(1): p. CD Miller, J., et al., Effect of increasing protein content of human milk fortifier on growth in preterm infants born at <31 wk gestation: a randomized controlled trial. The American Journal of Clinical Nutrition, (3): p Moya, F., et al., A new liquid human milk fortifier and linear growth in preterm infants. Pediatrics, (4): p. e Carlson, S.J. and E.E. Ziegler, Nutrient intakes and growth of very low birth weight infants. Journal of Perinatology, (4): p Olsen, I.E., et al., Higher protein intake improves length, not weight, z scores in preterm infants. Journal of Paediatric Gastroenterology & Nutrition, (4): p
6 23. Arslanoglu, S., G.E. Moro, and E.E. Ziegler, Preterm infants fed fortified human milk receive less protein than they need. Journal of Perinatology, (7): p Polberger, S.K., I.E. Axelsson, and N.C. Raiha, Urinary and serum urea as indicators of protein metabolism in very low birthweight infants fed varying human milk protein intakes. Acta Paediatrica Scandinavica., (8-9): p Boehm, G., et al., Development of urea-synthesizing capacity in preterm infants during the first weeks of life. Biology of the Neonate, (1): p Arslanoglu, S., G.E. Moro, and E.E. Ziegler, Adjustable fortification of human milk fed to preterm infants: does it make a difference? Journal of Perinatology, (10): p Klingenberg, C., et al., Enteral Nutrition and Use of Human Milk Fortifiers in Preterm Infants; An International Survey. Pediatric Research, 2010: p Cristofalo, E.A., et al., Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. Journal of Pediatrics, (6): p van Goudoever, J., et al., Amino acids and proteins, in Nutritional Care of Preterm Infants: Scientific Basis and Practical Guidelines, B. Koletzko, B. Poindexter, and R. Uauy, Editors. 2014, Karger. 30. Lucas, A., et al., Breast milk and subsequent intelligence quotient in children born preterm. Lancet, (8788): p Belfort, M.B., et al., Preterm infant linear growth and adiposity gain: trade-offs for later weight status and intelligence quotient. The Journal of Pediatrics, (6): p e2. 6
7 7 Appendix 1 Adding BMF when <50ml EBM Scoop for Nutriprem Breast Milk Fortifier (BMF) Nutriprem BMF should only be added to EBM - 1 sachet to 50ml Mix just prior to feeding where possible A purple feed tray cleaned using an alcohol wipe should be used If less than 50ml EBM is available at one time, the following is the only modification that should be made: Using a 2.5ml scoop Wash & dry with paper towel before and after use Fill scoop to overflowing and level off Do not pack down Add 1 level scoop to 25ml EBM Discard the remaining fortifier Each baby should have their own scoop kept in small named EBM bottle Wash and dry with paper towel before and after use (Scoops can be sterilised but NOT in steam steriliser) 7
8 8 Appendix 2 Table 1. Nutritional Profile of Preterm EBM and Breast Milk Fortifier Nutrient Unit Preterm Breast milk (mature) Nutriprem BMF Nutriprem BMF per 100ml per sachet (2.2g) 100ml preterm breast milk + 2 sachets Energy kcal Protein g 1.8 (1.3) (2.5) Carbohydrate g Fat g Vitamins Vitamin A microg ns 116 >232 Vitamin D microg ns 2.5 >5 Minerals Sodium mmol Potassium mmol Calcium mmol Phosphorus mmol Iron mg ns 0 ns Osmolality mosmol/kg 280 ~450 ns = not significant (0.0) - protein using mature preterm EBM though there is much variation in practice 8
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