SMA BMF Refresher Training PDF, Feb 2024

BMF REFRESHER TRAINING Niki Bradley Feb 2024 FOR INTERNAL USE ONLY Every year, millions of babies across the world are born preterm or LBW Background Preterm & LBW infants: Physiological immaturity & related health risks Due to their distinct physiological characteristics, preterm and LBW infants ha...

BMF REFRESHER TRAINING Niki Bradley Feb 2024 FOR INTERNAL USE ONLY Every year, millions of babies across the world are born preterm or LBW Background Preterm & LBW infants: Physiological immaturity & related health risks Due to their distinct physiological characteristics, preterm and LBW infants have specific nutritional needs and face Key challenges: High growth rate Depleted nutrient stores GI immaturity Despite providing the best nutrition for preterm infants, human milk alone cannot fully meet their specific nutritional needs Human milk fortification is thus the preferred feeding option for preterm and LBW infants FOR INTERNAL USE ONLY ESPGHAN recommendations for breast milk fortification FOR INTERNAL USE ONLY Why multicomponent fortifiers are recommended by ESPGHAN FOR INTERNAL USE ONLY A clinically proven multi-component​ breastmilk fortifier, specifically designed for the nutritional needs of breast milk* fed preterm infants​ Key Messages 01Iron Protein CONTAINS IRON The only breast milk fortifier available in the UK and Ireland to contain iron1,2 IMPROVED TOLERANCE 100% whey protein, partially hydrolysed for improved tolerability and adds 1.44 g protein per 100 ml expressed breast milk (3.6 g/100 kcal) 1,3 CLINICALLY PROVEN TO SUPPORT HEALTHY GROWTH (weight, length and HC) Safe & tolerated It improves the nutrient composition of human milk in line with the latest guidelines Lipids And proven to be safe, well tolerated and supports favorable gastrointestinal status 6,7 CONTAINS DHA & MCTS DHA (Docosahexaenoic Acid) to help support normal visual and brain development and MCTs (medium chain triglycerides) to help with fat absorption and provide readily available energy source.4,5 * mother’s milk or donor milk 1. SMA Gold Prem® Breast Milk Fortifier data card. Currently available from SMA Nutrition UK & Ireland website (accessed March 2023). 2. Cow & Gate Nutriprem Human Milk Fortifier datacard. Available at Cow & Gate nutriprem Human milk Fortifier (nutricia.co.uk) (accessed March 2023). 3. Mihatsch WA et al. Hydrolyzed protein accelerates feeding advancement in very low birth weight infants. Pediatrics 2002; 110(6): 1199–1203. 4. Lapillonne A. Enteral and parenteral lipid requirements of preterm infants. World Rev Nutr Diet 2014; 110: 82–98. 5. Birch EE et al. Dietary essential fatty acid supply and visual acuity development. Invest Ophthalmol Vis Sci 1992; 33: 3242–3253. 6. Rigo J et al. Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial JPGN 2017;65: e83–e93. 7. Rigo J et al. Comparative study of preterm infants fed new and existing human milk fortifiers showed favourable markers of gastrointestinal status. Acta Paediatrica, 2020, 109 (3), pp.527-533. FOR INTERNAL USE ONLY The growth study by Rigo et al. 2017 shows positive results for our SMA Gold Prem BMF & Rigo 2020 study shows positive impact on GI status ▪ provides more protein and fat compared to a control fortifier ▪ is safe, well tolerated and improves weight gain in preterm infants Favourable markers of GI status + 1. Rigo J et al. Growth and Nutritional Biomarkers of preterm Infants Fed a New Powdered HumanMilk Fortifier: A Randomized Trial, JPGN 2017;65: e83-e93, 2. Rigo J et al. Comparative study of preterm infants fed new and existing human milk fortifiers showed favourable markers of gastrointestinal status. Acta Paediatrica, 2020, 109 (3), pp.527-533. FOR INTERNAL USE ONLY Info from JENS 2023 on bovine BMF vs human milk based BMF Use of Bovine BMF vs human milk-based fortifier (HM BMF): no difference in body composition NEC incidence HM BMF (35.7%) vs Bovine BMF ( 34.5%); No diffs in feeding tolerance Therefore, difficult to justify routine use of Human BMF + too expensive (This is positive for us in that our BMF is considered superior and cheaper than the HM BMF) If no Donor Milk use preterm formula but do the formulas contain bioactive components e.g. HMOs (this poses well for us if we bring in preterm products containing HMOs) Need to Mimic MOM in fortifiers and preterm formulas (this is a plea for industry to further improve our products and look to include bioactive components e.g. HMOs in our products) FOR INTERNAL USE ONLY SMA BMF vs new Nutriprem BMF Preparation Packaging Cost Protein type Other properties Reformulated Cow and Gate Nutriprem Breast milk fortifier SMA Breast milk fortifier New 1g sachet size per 25ml of EBM replacing the current 2.2g sachet. 1g sachet per 25mls of EBM Dosage will therefore change to 2 x 1g sachets per 50ml (currently 1 x 2.2g sachet per 50ml) 50 x 1g sachet ?? Extensively hydrolysed Updates to the formulation, including addition of: Medium Chain Triglycerides (from vegetable oils(coconut and/or palm oil)) 72 x 1g sachet per box £40.37 per 6 boxes (1 box of 72 sachets = £6.73 = 9p per 1 g sachet) Partially hydrolysed MCT fats DHA Phospholipid-bound long chain polyunsaturated fatty acids (from Mortierella alpina and fish oil) Beta-palmitate (from milk fat) Kcals/100mls(4 sachets) with mature EBM Protein /100mls(4 sachets) with mature EBM Fat /100mls(4 sachets) with mature EBM CHO/100mls (4 sachets) with mature EBM Ca/100mls (4 sachets) with mature EBM Po4/100mls (4 sachets) with mature EBM Na/100mls (4 sachets) with mature EBM Iron/100mls (4 sachets) with mature EBM Vitamin D /100mls (4 sachets) with mature EBM 85kcals/100mls 86kcals/100mls 2.62g/100mls 2.7g/100mls 4.8g/100mls 4.8g/100mls 8.7g/100mls 8.5g/100mls 103.2 mg/100mls 110 mg /100mls 53 mg/100mls 59 mg/100mls 48 mg /100mls 51.8 mg/100mls 5mg/kg/day should be avoided to avoid the possible risk of ROP. Therefore, at the levels of iron that the SMA BMF provides, there should not be any issues. As mentioned above the clinical trial was very positive and showed no incidences of such 5. Iron containing BMF has been used routinely in Europe for >10 years and units here in the UK have also used it successfully for >4years. FOR INTERNAL USE ONLY SMA BMF recommended reconstitution instructions are as follows: 1. Each feeding device (bottle, syringe or container for tube feed) must be prepared individually just before feeding. 2. If frozen human milk is used, gradually defrost the human milk in refrigerator (under 4ºC). DO NOT use a microwave oven or allow to sit at room temperature to defrost. 3. Shake or swirl before pouring into the feeding device. 4. Pour only required amount of expressed human milk to be fortified into the feeding device. FAQs 5. Before mixing with fortifier, warm up human milk to body temperature. DO NOT use a microwave oven. 6. Separate the sachets and take only one sachet of 1g for standard preparation. Add the required quantity of SMA GOLD PREM BMF to desired quantity of lukewarm human milk (35ºC - 40ºC), using the standard preparation (1g per 25ml of human milk) or a specially calculated quantity if a different reconstitution is prescribed). 7. Cap and gently shake until powder is fully dissolved and FEED IMMEDIATELY. 8. Discard all unfinished quantities of fortified human milk after each feed. 9. Opened sachet should be used immediately or discarded. 10. For tube feeding: once fortified human milk is prepared, it should be used within 4 hours. FOR INTERNAL USE ONLY Can fortifier be added to cold EBM and then stored in the fridge and if so for how long? We don’t recommend adding BMF to cold EBM and then storing it. We recommend that before mixing with BMF, the EBM is warmed up to body temperature (35-40OC) and then the required quantity of SMA BMF be added to the desired quantity of lukewarm EBM and then used within 4 hours. Why do we add BMF to warmed EBM? The recommendation to add BMF to warmed breastmilk is to help the powder dissolve (rather than for infection control). If their policy is to mix cold, then they will need to ensure that before administering the fortified EBM they warm it to the required temperature and check that it has dissolved properly and then administered to the infant at body temp. FOR INTERNAL USE ONLY If fortifier is added to warmed milk, how long can it be left out at room temperature for? We recommend that the once the fortified EBM is prepared it should be used within 4 hours. If fortifier is added to warmed milk, can it then be put back in fridge and then rewarmed later for another feed? For Fortified EBM: Ideally, we recommend feeding fortified breastmilk at immediate reconstitution, or if tube feeding, to use within 4 hours BUT the BDA recommend that you can store unused fortified EBM in the fridge and use within a maximum of 12 hours (see page 28, section 6.9 in the document which can be accessed via this link below) https://www.bda.uk.com/uploads/assets/a230ba75-c66a-41578ff6a6ca9f2eb971/2019sfuguidelines.pdf FOR INTERNAL USE ONLY Difference between Osmolality and osmolarity Both are expressions of concentrations of fluids Osmolarity : Osmolarity is the concentration of a solution expressed as osmoles of solute particles per liter of solution i.e. osmolarity measures the number of particles per liter. It doesn’t depend on the type of compound that is dissolved in the solution, it just measures the number of particles present there. It is affected by the changes in the solvent (water). If the volume of the solution is increase or decreased, the volume considered for the calculation is changed accordingly. It also depends temperature and pressure because these affect the volume and solubility of compounds. Osmolality : Osmolality is the concentration of a solution expressed as the total number of solute particles per kilogram. As mass is independent of pressure and temperature, these cannot affect the osmolality of a solution. However, a change in water content can highly affect osmolality because it changes the mass of the solution. FOR INTERNAL USE ONLY FAQs cont. FOR INTERNAL USE ONLY FOR INTERNAL USE ONLY Does SMA BMF meet the iron requirements of a preterm infant? A. There is no need for Iron supplementation if using SMA Breast Milk Fortifier. 110-170ml/kg/day of SMA BMF will meet the iron need of preterm infants as recommended by ESPGHAN. ESPGHAN 2022 Guidelines: A daily iron intake of 2–3mg/kg/d starting at 2 weeks of age is recommended for VLBW infants. Infants who receive erythropoietin treatment need a higher dose (up to 6mg/kg/d). Since individual iron status in VLBW infants is highly variable, depending on the number of received blood transfusions and blood losses from phlebotomy, it is recommended to follow these infants with repeated measurements of serum ferritin. If ferritin 3mg/kg/d should be avoided in most cases because of possible adverse effects. If ferritin is >300 µg/L, which in the absence of ongoing inflammation and liver disease usually is the result of multiple blood transfusions, iron supplementation and fortification should be discontinued until serum ferritin falls below this level. Iron supplements or intake of iron-fortified formula in the recommended doses should be continued until 6–12 months of corrected age. Like all infants, preterm infants should receive iron-rich complementary foods from 6 months of age. Delayed umbilical cord clamping, whenever feasible, is recommended for all preterm infants. ESPGHAN Recommendations (2010 & 2022) Iron (mg) 2-3 (-6) mg/kg/d @120ml @150ml 1.87mg 2.2mg 2.8mg 1.89 mg 2.3 mg 2.8 mg Iron content of Per 100ml feeds SMA Breast Milk Fortifier + Mature BM SMA BMF + Preterm BM Iron supplements used in units include Sytron and Galfer. 0.5ml of Sytron provides 2.75mg of Iron daily for infants 1.5kg 5mls of Galfer provides 45mg of Iron daily 0.5ml of Galfer provides 4.5mg of Iron daily FOR INTERNAL USE ONLY IRON CONTENT OF FEEDS 1 ml sytron ESPGHAN Recommendati ons (2022) Iron (mg) 5.5mg NP BMF + Mature BM SMA GP1 SMA BMF + Mature BM Per 100ml Per 100ml 5mg/kg/day should be avoided to avoid the possible risk of ROP. Therefore, at the levels of iron that the SMA BMF provides, there should not be any issues. As mentioned above the clinical trial was very positive and showed no incidences of such 5. Iron containing BMF has been used routinely in Europe for >10 years and units here in the UK have also used is successfully for >4years. FOR INTERNAL USE ONLY QUESTION ON IRON IN OUR BMF AND ROP: We understand their concern and would like to reassure them that the clinical trial using our BMF with iron (Rigo 2017) showed that despite the increase in the iron content in our BMF, there is no incidence of ROP. The iron level in the fortified Breast milk is within the limits of ESPGHAN recommendations. See previous info and list of references and links to the articles or abstracts. ESPGHAN 2022 recommends 2-3mg/kg/day (1.8 - 2.7 mg/100kcal) and guidelines support the use of iron-fortified human milk in preterm infants. 1,2 Using SMA Gold Prem® Breast Milk Fortifier increases the iron content from 0.13 mg/100kcal (unfortified human milk) to 2.4mg/100kcal (human milk fortified with SMA BMF) – therefore at 150ml/kg/day of fortified EBM iron provision is 2.8mg/kg/day which is within the ESPGHAN recommendations and is an amount of iron that is similar to that provided in a preterm formula. Iron within the fortifier has the benefit of not increasing the osmolality as much as if adding single nutrients to EBM and reduces nursing time3. In-vivo safety data shows no increase in adverse events (including sepsis and NEC) with the use of a BMF containing iron. 3,4,5 It has been proven that iron supplementation through a human milk fortifier as soon as the infant reaches 100 ml/kg/d is safe, well tolerated and this early intervention may even provide some benefits in terms of reducing the need for blood transfusions and possibly improving motor and cognitive functions in the long term. 3,6 It may also reduce the risk of iron deficiency between 2 and 6 months of age. 7 The timing of when the fortifier was started in these clinical trials ranged from 7-61 days and some were started on BMF even at the very start of enteral feeding. Concerns around oxidation is only with very high levels of iron. ESPGHAN 2010 indicate that doses of >5mg/kg/day should be avoided to avoid the possible risk of ROP. Therefore, at the levels of iron that the SMA BMF provides, there should not be any issues. As mentioned above the clinical trial was very positive and showed no incidences of such 5. Iron containing BMF has been used routinely in Europe for >10 years and units here in the UK have also used it successfully for >4years. FOR INTERNAL USE ONLY IS BMF STERILE? SMA BMF is not sterile, but it is pasteurised (the liquid intermediate is heat treated prior to the spray drying. This is done to decrease the vegetative bacterial load). The product is manufactured in a purpose-built manufacturing environment which is accredited with the Food Safety Management System (HACCP) ISO 22000:2018 and the Quality Management System ISO 9001:2015. This means that the production environment in which the product is manufactured and packed is strictly controlled. In-process and finished product testing includes physical, nutritional and microbiological analysis, which verifies the product is compliant with all test specifications prior to release. FOR INTERNAL USE ONLY IS SMA BMF SUITABLE FOR USE IN FORTIFYING MEBM for NJ FEEDING? We don’t have specific studies looking at its use in NJ feeding, but from a composition perspective it should be OK to fortify EBM for NJ feeding based on the following: It is partially hydrolysed protein so may be suitable Contains MCTs so it may be suitable Osmolality is