ROYAL HOSPITAL FOR WOMEN Approved by

*1 scoop = 4.3 g. 8. Alfare – Semi-elemental Formula. Strength. Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality,. mOsm/kg. Standard: 1 scoop to 30 mL.

125 KB – 7 Pages

PAGE – 1 ============
ROYAL HOSPITAL FOR WOMEN Approved by LOCAL OPERATING PROCEDURES Quality & Patient Care Committee NEONATAL SERVICES DIVISION Date: 16/11/17 FORTIFIERS AND FORMU LA PREPARATIONS This LOP is deve loped to guide safe clinical practice in Newborn Care Centre (NCC) at The Royal Hospital for Women. Individual patient circumstances may mean that practice diverges from this Local Operations Procedure (LOP). Using this document outside the Royal Hospital for Women or its reproduction in whole or part, is subject to acknowledgement that it is the property of NCC and is valid and applicable for use at the time of publication. NCC is not responsible for consequences that may develop from the use of this doc ument outside NCC. INTRODUCTION Expressed breast milk (EBM) with multi – nutrient fortification is our 1 st preference in extreme to very preterm infants . Occasionally, formula preparations are used as medically indicated. Th is guideline assist the staff in calculating the amount of fortifier/powdered formula to be added to set volumes of sterile water or standard formula to achieve the desired calories. Composition of breast milk varies among individuals and from feed to feed within the same individual. Est imated average calorie content of expressed breast milk is 20 kcal/30 mL or 67 kcal/100 mL. The guide is calculated in a pragmatic way with the assumption that breast milk or standard formula preparation on average provide 20 kcal/30 mL or 67 kcal/100 mL. Standard Formulas slightly differ in the calorie and nutrient content, but for practical purposes, average calorie content of the standard formula is considered equivalent to breast milk . THE SCOPE This guideline includes commonly used fortifiers and for mulas in our Newborn Care Centre (NCC). Preparations not used in our NCC are beyond the scope of this guideline. Preparation and administration guidelines – Please refer to relevant nursing protocol. AIM To guide the amount of fortifier or powdered formul a to be added to the set volumes of expressed breast milk or sterile water to provide prescribed concentration of enteral nutrients for the neonate. PATIENT Neonates. STAFF Medical and nursing staff. EQUIPMENT As required . CLINICAL PRACTICE Medical sta ff to prescribe on the fluid chart: type of enteral feeds (e.g. expressed breast milk, formula, fortifier), calorie content per 30 mL a nd the volumes to be fed . Example : For a calculated weight of 1 Kg at 150 ml/kg/day 1 hourly feeds of Peptijunior 22 ca l preparation o Prescribe: Peptijunior 22 kcal/30 mL 6 ml x 1 x 24 or 6 mL 1 hourly. Nursing staff to determine the amount of powdered formula/fortifier to be added to the set volume of sterile water/EBM/formula using the following tables:

PAGE – 2 ============
2. ROYA L HOSPITAL FOR WOMEN Approved by LOCAL OPERATING PROCEDURES Quality & Patient Care Committee NEONATAL SERVICES DIVISION Date: 16/11/17 FORTIFIERS AND FORMU LA PREPARATIONS Human Milk Fortifiers Multi – component Fortifiers 1. S26 – Gold Alula HMF (Human Milk Fortifier) a. Each 1 g sachet provides 3.6 kcal, 0.25 g protein, 4.5 mg (0.2 mmol) sodium, 23 mg (1.2 mmol) calcium, 11 mg (0.7 mmol) phosphorus , 1.8 mg Docosahexaenoic acid (DHA) and 2. 7 mg Arachidonic acid. Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL final solution* Sodium, mmol/L final solution Osmolality, mosm/kg 1 sachet in 50 mL 22 73 1.6 1.6 313 1 sachet in 25 mL 24 80 2.1 2.0 357 *Average protein , sodium , calcium and ph osphorus in unfortified human milk is taken as 1.1 g/100 mL , 1.2 mmol/L , 1.3 mmol/L and 0.9 mmol/L respectively. 8,9 2. Nutricia BMF Fortifier (also known as Nutriprem Breastmilk Fortifier) a. Each 2.2 g sachet provides 0.6 g protein, 18 mg (0.8 mmol) sodium, 3 3 mg (1.7 mmol) calcium and 19 mg (1.2 mmol) phosphorus Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL final solution* Sodium, mmol/L final solution Osmolality, mosm/kg 1 sachet in 100 mL 22 75 1.7 2 No data 2 sachets in 100 mL 24 81 2.3 2.8 450 *Av erage protein , sodium , calcium and phosphorus in unfortified human milk is taken as 1.1 g/100 mL , 1.2 mmol/L , 1.3 mmol/L and 0.9 mmol/L respectively. 8,9 3. PreNAN HMF (Replaced FM85) a. Each 1 g sachet provides 0.4 g protein, 9.2 mg (0.4 mmol) sodium, 19 mg (1. 0 mmol) calcium, 11 mg (0.7 mmol) phosphorus Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL final solution* Sodium, mmol/L final solution Osmolality, mosm/kg 1 g in 50 mL 23 76 1.9 2 No data 1 g in 25 mL 25 84 2.7 2.8 390 *Average protein , sodium , c alcium and phosphorus in unfortified human milk is taken as 1.1 g/100 mL , 1.2 mmol/L , 1.3 mmol/L and 0.9 mmol/L respectively. 8, 9 Protein Fortifiers 1. Beneprotein 100% Whey protein. PDCAAS (Protein Digestibility Corrected Amino Acid Score): 100. Osmolalit y: 44 mOsm/kg water. Refer to Beneprotein Guideline. 2. Protifar Concentrated milk protein with emulsifier (soy lecithin). Protein is predominantly casein (4: 1 Casein to whey ratio). PDCAAS : 93. Also contains minerals including calcium and phosphorus . It is not currently used in our NICU.

PAGE – 3 ============
3. ROYAL HOSPITAL FOR WOMEN Approved by LOCAL OPERATING PROCEDURES Quality & Patient Care Committee NEONATAL SERVICES DIVISION Date: 16/11/17 FORTIFI ERS AND FORMULA PREP ARATIONS Formula Preparations 1. Aptamil Gold+ Term Ready to Feed Formula Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/kg 20 66 1.3 g 315 Protein Casein/Whey Ratio 38%/62% Hydrolysed Protein No 2. Aptamil Gold+ Preterm Ready to Feed Formula Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/kg 24 79 2.6 g 375 Protein Casein/Whey Ratio 38%/62% Hydrolysed Protein No 3. Aptamil Gold+HA Term Ready to Feed Formula Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/kg 20 65 1.5 380 Protein Casein/Whey Ratio 100% whey Hydrolysed Protein Yes (Partial) 4. Aptamil Gold Pronutra Stage 1 (Tin) (Not Ready to Feed Preparation) Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/kg Standard: 1 scoop to 50 mL 19 64 1.4 g 326 1 scoop to 45 mL 21 71 N/A 1 scoop to 40 mL 24 80 N/A 1 scoop to 35 mL 27 91 N/A 1 scoop to 32 mL 30 100 N/A *1 scoop = 7.4 g 5. S26 – Gold Alula Low Birth Weight Re ady to Feed (LBW RTF) formula Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/kg 24 80 2.69 g Protein – Casein/Whey ratio 40%/60% Hydrolysed protein No 6. S26 – Gold Alula Newborn (Term) Ready to Feed (LBW RTF) formula Strength Kca l/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/kg 20 66 1.28 g Protein – Casein/Whey ratio 35%/65% Hydrolysed protein No

PAGE – 4 ============
4. ROYAL HOSPITAL FOR WOMEN Approved by LOCAL OPERATING PROCEDURES Quali ty & Patient Care Committee NEONATAL SERVICES DIVISION Date: 16/11/17 FORTIFIERS AND FORMU LA PREPARATIONS 7. Pepti – Junior Semi – elemental formula. Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/kg Standard: 1 scoop to 30 mL 20 66 1.8 g 210 1 scoop to 27 mL 22 74 2.0 g N/A 1 scoop to 25 mL 24 79 2.2 g N/A 1 scoop to 22 mL 27 90 2.5 g N/A 1 scoop to 20 mL 30 99 2.7 g N/A *1 scoop = 4.3 g 8. Alfare Semi – elemental Formula. Strength Kcal/30 mL Kc al/100 mL Protein, g/100 mL Osmolality, mOsm/kg Standard: 1 scoop to 30 mL 20 67 2.0 217 1 scoop to 27 mL 22 75 2.2 N/A 1 scoop to 25 mL 24 81 2.4 N/A 1 scoop to 22 mL 27 92 2.7 N/A 1 scoop to 20 mL 30 101 3.0 N/A 1 scoop=4.5 g. 9. Neocate Full elem ental aminoacid formula Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/kg Standard: 1 scoop to 30 mL 20 67 1.9 340 1 scoop to 27 mL 22 75 2.1 380 1 scoop to 25 mL 24 81 2.3 410 1 scoop to 22 mL 27 92 2.6 470 1 scoop to 20 mL 30 101 2.9 530 *1 scoop = 4.6 g 10. Elecare Full elemental aminoacid formula Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL # Osmolality, mOsm/kg Standard: 1 scoop to 60 mL 20 68 2.2 309 1 scoop to 55 mL 22 75 2.4 N/A 1 scoop to 50 mL 25 82 2.7 N/A 1 scoop to 45 mL 27 91 2.9 N/A 1 scoop to 40 mL 31 102 3.3 N/A *1 scoop = 9.4 g. #Protein equivalents. 11. Alfamino Full elemental aminoacid formula. Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL # Osmolality, mOsm/kg Standard: 1 scoop to 30 mL 21 70 1.9 32 0 1 scoop to 26 mL 24 81 2.2 N/A 1 scoop to 22 mL 29 96 2.6 N/A 1 scoop to 20 mL 32 105 2.9 N/A *1 scoop = 4.6 g . #Protein equivalents. Each 100 ml standard preparation contains 1.9 g protein, 7.9 g carbohydrate and 3.4 g fat.

PAGE – 5 ============
5. ROYAL HOSPITA L FOR WOMEN Approved by LOCAL OPERATING PROCEDURES Quality & Patient Care Committee NEONATAL SERVICES DIVISION Date: 16/11/17 FORTIFIERS AND FORMU LA PREPARATIONS 12. Monogen Special f ormula with whey protein and high Medium Chain Triglycerides (MCT) as fat. Long chain triglycerides are low . Used in chylothorax, intestinal lymphagiectasia, Long Chain Fatty Acid Oxidation defects (LCHADs), primary hypolipoproteinemia Type 1, severe intes tinal malabsorption with steatorrhea. Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/kg Standard: 1 scoop to 30 mL 22 .5 75 2. 4 g 235 1 scoop to 25 mL 27 89 2.9 g N/A 1 scoop to 22 mL 31 102 3.3 g N/A *1 scoop = 5.6 g. Each 100 ml st andard preparation contains 2.4 g protein, 11.6 g carbohydrate, 2.2 g fat and 1.6 mmol Na. 13. Locasol Special low calcium formula. Almost no calcium in the preparation. Used for infants with hypercalcemia.Always discuss with Endocrinologist prior to comme ncing this formula. Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/kg Standard: 1 scoop to 30 mL 20 66 1.9 g 310 1 scoop to 25 mL 24 79 2.3 g N/A 1 scoop to 22 mL 27 90 2.6 g N/A *1 scoop = 4.4 g. Each 100 ml standard preparation co ntains 1.9 g protein, 7 g carbohydrate, 3.4 g fat, 1.2 mmol Na, <0.5 mmol Ca and 1.5 mmol Phosphate. 14. Kindergen Special formula for infants in renal failure . Low potassium, calcium, phosphorus and vitamin A in the preparation. Please note: Standard prep aration is 30 kcal/30 mL. Always discuss with renal team prior to commencing this formula. Contains low calcium, phosphorus and Vitamin A and needs closer monitoring for any deficiencies. Strength Kcal/30 mL Kcal/100 mL Protein, g/100 mL Osmolality, mOsm/ kg 1 scoop to 33 mL 20 66 1.0g 1 scoop to 30 mL 22 73 1.1g 1 scoop to 28 mL 24 80 1.2g 1 scoop to 21 mL 30 101 1.5 g 215 *1 scoop = 5 g. Each 100 ml standard preparation contains 1.5 g protein, 11.8 g carbohydrate, 5.3 g fat, 2 mmol Na, 0.62 mmol K , 0.56 mmol Ca and 0.60 mmol Phosphate. DOCUMENTATION Integrated notes Fluid Chart NICUS database Medication chart for Beneprotein EDUCATIONAL NOTES Definitions (Pearson 2013): o Solute A substance that is dissolved in a liquid (solvent) to form a sol ution. o Osmole A unit of osmotic pressure equivalent to the amount of solute that dissociates in solution to form one mole of particles. o Osmolality The concentration of a solution in terms of osmoles of solute per kilogram of solvent. o Osmolarity The c oncentration of a solution in terms of osmoles of solute per litre of solution. PAGE - 6 ============ 6. ROYAL HOSPITAL FOR WOMEN Approved by LOCAL OPERATING PROCEDURES Quality & Patient Care Committee NEONATAL SERVICES DIVISION Date: 16/11/17 FORTIFIERS AND FORMU LA PREPARATIONS In 1976, the American Academy of Pediatrics (AAP) recommended that the osmolarity of infant formula should not exceed 400 mOsm/l. This was a consensus view and not based o n any strong evidence. 2 However, osmolarity is difficult to measure since the volume of solution changes with the amount of solute added as well as with changes in temperature and pressure. Osmolality is easier to evaluate and is more commonly used because the amount of solvent will remain constant regardless of changes in temperature and pressure. Currently, the standard measurement of feed concentration is osmolality. Historical consensus view is that the osmolality of enteral feeds should not exceed 45 0 mOsm/kg (which approxi mates to an osmolarity of 400 mO sm/ L ). Average osmolality of human milk is 281 - 297 mOsm/kg H 2 0. Formula preparations and t he addition of human milk fortifiers have higher osmolality than unfortified human milk. However, a ll these p reparations in common use have osmolality below 450 mOsm/kg. The normal physiological response to an increase in osmolality is to delay gastric emptying and allow dilution of the contents with hypo - osmolar gastric and intestinal secretions. 1 Current eleme ntal and amino acid formulas have osmolalities similar to that of preterm formula. Average osmolalities of feeds: 1 enteral feeds Osmolality (m O sm/kg H 2 O ) Preterm Human milk 276 Term Human milk 300 Human milk with Nutricia Breast Milk Fortifier 450 Pr eterm Aptamil Gold Ready to Feed Formula 375 Term Aptamil Gold Ready to Feed Formula 315 Peptijunior Semi elemental Formula 210 Alfare Semi elemental Formula 217 Neocate Full elemental formula 340 Elecare Full elemental Formula 309 Alfamino Full elemental Formula 320 Locasol formula 310 Kindergen 215 Hyperosmolar feeds and NEC: The suggestion of hyperosmolar feeds as a causative factor for NEC came mainly from studies in 1970s and the osmolality of feeds were in excess of 500 m O sm/kg. 5,6 Subsequent meta - analysis of trials of nutrient fortification have not shown evidence of an increase in NEC. 7 Protein content is variable in human milk with a significant decline from transitional milk to mature milk [(1.9 g/100 ml (2.8 g/100 kcal) in pre term transitional 6 - 10 days milk; 1.5 g/100 ml (2.2 g/100 kcal) in preterm mature 22 - 9 The average protein content of human milk is 1.1 g/100 ml (1.7 g/100 kcal). 8 The commercial fortifiers p rovide an additional protein between 1.2 - 1.6 g/100 m L depending on the brand [e.g. Nutricia BMF Fortifier 1.2 g/100 ml (1.8 g/100 kcal) and PreNAN HMF 1.6 g/100 ml (2.4 g/100 kcal)]. Semi - elemental formulas contain extensively hydrolysed whey protein. Exam ples are Pepti - junior and Alfare. E lemental (monomeric) formulas contain individual amino acids, glucose polymers, and fat s with only about 2% to 3% of calories derived from long chain triglycerides (LCT) . Semi - elemental (oligomeric) formulas contain pept ides of varying chain length, simple sugars, glucose polymers or starch and fat, primarily as medium chain triglycerides (MCT). RISK RATING Low 125 KB – 7 Pages