Melinda Elliott, MD Senior Director, Clinical Education and Professional Development, Prolacta Bioscience Neonatologist, Pediatrix Medical Group of

Transcription

1 Melinda Elliott, MD Senior Director, Clinical Education and Professional Development, Prolacta Bioscience Neonatologist, Pediatrix Medical Group of Maryland

2 Breast Milk is for Babies, Cows Milk is for Cows

3 Breastfeeding and The Use of Human Milk/ Donor Human Milk for the High- Risk Infant* All preterm infants should receive human milk. Priority should be given to providing donor human milk to infants <1500 g birthweight. Human milk should be fortified, with protein, minerals, and vitamins to ensure optimal nutrient intake for infants weighing <1500 g birthweight. Pasteurized donor human milk, appropriately fortified, should be used if mother s own milk is unavailable or its use is contraindicated. Methods and training protocols for manual and mechanical milk expression must be available to mothers. Neonatal intensive care units should possess evidence-based protocols for collection, storage, and labeling of human milk. Neonatal intensive care units should prevent the misadministration of human milk The use of donor human milk in appropriate high-risk infants should not be limited by an individual s ability to pay. Policies are needed to provide high-risk infants access to donor human milk on the basis of documented medical necessity, not financial status. American Academy of Pediatrics. Breastfeeding and the use of human milk: section on breastfeeding. Pediatrics. 2012;129(3):e827-e841. doi: /peds CDC. What to Do if an Infant or Child Is Mistakenly Fed Another Woman's Expressed Breast. Milk. Accessed May 10, 2017.

4 Is All Donor Milk the Same? Generally a safe product, but some may be better than others for growth in extremely premature infants HMBANA: Donors screened verbally. Blood screened for HIV, Hep B and C, Syphilis. Milk pooled from 3-5 donors, Holder pasteurized, cultured for bacteria Prolacta: Donors screened with questionnaire. Blood screened for HIV, Hep B and C, syphilis. Milk screened for drugs, nicotine, and is DNA fingerprinted to match to donor. Adulteration and dilution testing done before adding to production. Holder pasteurized, cultured at multiple points in process, viral PCR screening for HIV, HBV, HCV. Full nutritional analysis done with nutritional values on labels. Sterilized, shelf stable donor milk: Fat loss issues in practice. Coming out with higher calorie product. No published data on nutritional benefit or how nutritional content measured.

5 Why is Human Milk Critical for Premature Newborns? Infants with GA 28 weeks or BW 1500 g have very immature GI tracts Neonatal GI tract must be colonized with normal bacteria after birth Evidence of abnormal bowel colonization prior to development of NEC (Mai PLOS One 2011) BW = birthweight; GA = gestational age; NEC = necrotizing enterocolitis.

6 What is an Exclusive Human Milk Diet (EHMD)? Diet consisting of 100% Human Milk Derived Products Mother s Own Milk (MOM) Preferred Donor Milk if MOM not available Only Human Milk Derived Fortifiers (Protein, Fats, Carbohydrates)

7 More Advantages of Human Milk for Premature Newborns EHMD had lower rate of NEC than diet of MOM/Donor Milk and Bovine fortifier (Sullivan S. J Pediatr, 2010). EHMD (Donor Milk and Prolact+ fortifiers) had lower PN days and lower NEC (Cristafalo E. J Pediatr, 2013) Decreased incidence of NEC seen in those infants fed human milk (Bhatia J. Ann Nutr Metab, 2013) EHMD= Exclusive Human Milk Diet; PN= Parenteral Nutrition

8 Any Human Milk and ROP Any amount of HMI is significantly associated with protection (compared with no HMI) from the risk of developing all ROP (all stages of ROP pooled together) and Severe ROP ( stage 3 and ROP requiring intervention). An exclusively human milk-fed infant in the first month after birth may have better health outcomes compared with an infant who received low doses of human milk throughout the NICU stay. Bharwani SK, et.al. Systematic review and meta-analysis of human milk intake and retinopathy of prematurity: a significant update. Journal of Perinatology (2016) 36, ; doi: /jp

9 Exclusive Human Milk Diet and ROP Reduction in severe ROP seen with exclusive human milk diet 10.7% in bovine fortifier group vs. 1.6% in EHMD group O Connor D. Comparison Of A Human Milk-Based To A Bovine-Based Human Milk Fortifier In Infants Born Less Than 1250 G: A Randomized Clinical Trial. Presented at PAS San Francisco, CA.

10 Sepsis Major components of human milk are not primarily for nutrition, but for host defense. Hanson, LA Immunobiology of human milk (2004).

11 Sepsis Lower odds of sepsis and associated NICU costs with higher amounts of human milk. Patel AL, et. Al. Impact of Early Human Milk on Sepsis and Health-Care Costs in Very Low Birth Weight Infants. J Pernatol. 2013;33:

12 Greater Mortality and Morbidity in Extremely Preterm Infants Fed a Diet Containing Cow Milk Protein Products EHMD had lower mortality, NEC, surgical NEC, sepsis For each 10% increase in the intake of other than an EHMD, the risk of NEC increases by 11.8%, and the risk of surgical NEC increases by 21%... For each 10% increase in the intake of other than an EHMD, there was a 17.9% increase in risk of sepsis. Abrams SA, et. Al. Greater Mortality and Morbidity in Extremely Preterm Infants Fed a Diet containing Cow Milk Protein Products. Breastfeeding Medicine. 2014;9:1-5

13 More Human Milk = More Chance of Remaining NEC Free Combined Clinical Trial Data Analysis Probability of Remaining NEC Free vs. % Cow Milk-Based Diet P (remaining NEC Free) Percent (%) Total Diet from Cow Milk-Based Abrams SA, et. Al. Greater Mortality and Morbidity in Extremely Preterm Infants Fed a Diet containing Cow Milk Protein Products. Breastfeeding Medicine. 2014;9:1-5

14 More Human Milk = More Chance of Remaining Sepsis Free Combined Clinical Trial Data Analysis Probability of Remaining Sepsis Free vs. % Cow Milk-Based Diet Abrams SA, et. Al. Greater Mortality and Morbidity in Extremely Preterm Infants Fed a Diet containing Cow Milk Protein Products. Breastfeeding Medicine. 2014;9:1-5

15 Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk- Based Diet 1587 Infants <1250 g 4 centers in 4 states Retrospective cohort study EHMD had significantly lower: o NEC o Mortality o Late Onset Sepsis o ROP o BPD Hair AB, et.al. Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet. Breastfeed Med.2016:11(2):1-5.

16 Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk- Based Diet Hair AB, et.al. Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet. Breastfeed Med.2016:11(2):1-5.

17 Decreased Cost and Improved Feeding Tolerance in VLBW Infants Fed an Exclusive Human Milk Diet Exclusive Human Milk Diet (EHMD) leads to decreased feeding intolerance, shorter time to full feeds, shorter length of stays, less ROP, less BPD, and lower costs for extremely premature and VLBW infants. Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol 2015 Nov 12 (DOI: /jp.2015)

18 Additional Days to Full Feeds 12 P= p= Bovine Mixed Formula Human (control) 0 Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol 2015 Nov 12 (DOI: /jp.2015).

19 Feeding Intolerance: Number of Times Feeds Held for > 24 hrs Fisher s exact test P= % 17% 17% 29% 7% 27% 94% 35% 66% 66% 37% H B M F Groups Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol 2015 Nov 12 (DOI: /jp.2015).

20 Feeding Intolerance Has a Price Estimated additional cost for stopping feeds $29, per infant, excluding NEC babies from analysis (p<0.05)* - Includes cost of: orestarting or increasing TPN/more TPN Days olonger length of stay oclinical investigation (xrays, blood cultures, labs, etc.) *Data to be presented at INAC 2017

21 What About Growth? Good growth is what we strive to attain Only adequate weight gain without associated good growth in length and head circumference may lead to babies with increased body fat mass and poorer developmental outcomes!

22 It s All Interconnected! Good Growth Well tolerated Feeds CVL out early Off the vent quickly Poor Growth Delayed feeds No feeding protocol Maternal infection Sepsis RDS BPD ICH NEC ROP

23 Growth and Nutrition Basics Nutritional requirements for infants vary by body weight, gestational age, and metabolic demands. Preterm infants have greater requirements than those of the full term infants due to: o Decreased nutrient (aka fat) stores o Altered gastrointestinal absorption o Increased caloric expenditure o Need for rapid growth

24 Growth and Feeding Basics Early enteral feedings and a standardized approach to feeding have been shown to improve intestinal motility, stimulate hormonal response, improve feeding tolerance, promote earlier achievement of full feeds, and decrease problems related to prolonged TPN in the VLBW infant. Many clinicians do not adhere to the feeding protocol even if there is one. They base their decisions on previous experiences which will most likely lengthen the time to full volume feeds. Decisions are also based previous experiences with cow milk fortifiers.

25 Growth Basics Weight Goals o wks GA g/day o o o o o wks GA g/day wks GA g/day wks GA g/day wks GA g/day Mean = 25 g/day (or 15 gm/kg/day growth velocity from birth to discharge) Length and Head Circumference Goal o ~1 cm/week

26 Nutrition Basics: How much, How often, And How variety is the bane of our existence!

27 Nutrition Basics Fluid requirements at goal* 150 ml/kg/d (+/- ~30 ml/kg/day) Calories* AAP: kcal/kg/d ESPGHAN: kcal/kg/d Protein* AAP: g prot/kg/d ESPGHAN: g prot/kg/d Protein:Energy (P:E) ratio g/100 kcal *Needs can vary with sepsis, BPD, CHD, etc.

28 Nutrition Basics TPN (aka protein) should start on Day 1 Enteral feeds should start within hours of birth when medically feasible (vast differences in opinion/comfort level) Feeds should be advanced by ml/kg/day until goal feeding volumes are met (goal volume +/ ml/kg/day) o Babies can be fed more rapidly with the EHMD o Some medical providers are unfamiliar with this rapid feed advancement and its safety. They are basing their judgement on their experience with cow based fortifiers. (And they are afraid!)

29 Working Up On Feeds Parenteral Nutrition Optimal TPN Weaning TPN (Concentrate TPN protein to allow for attainment of protein goals) Enteral Nutrition Low volume enteral feeds (trophic/gut priming) Increasing enteral feeding volume (20->26 cal/oz BM) Discontinuing TPN Suboptimal volume enteral feeds when CVL is pulled (TRANSIENT CALORIE DEFICIT)

30 Enteral Nutrition Methods of Feeding: o Nasogastric (NG) o Nasojejunum (NJ), must be continuous o Orogastric (OG) o By mouth (PO), not until ~34 weeks corrected gestational age

31 Feeding Guidelines Early enteral feedings and a standardized approach to feeding have been shown to improve intestinal motility, stimulate hormonal response, improve feeding tolerance, promote earlier achievement of full feeds, and decrease problems related to prolonged TPN in the VLBW infant. Many clinicians do not adhere to the feeding protocol even if there is one. They base their decisions on previous experiences which will most likely lengthen the time to full volume feeds. Decisions are also based previous experiences with cow milk fortifiers.

32 Human Milk Feeding Supports Adequate Growth in Infants 1250 Grams Birth Weight Lower rate extrauterine growth restriction (22%, excluding those SGA at birth) Mean weight gain of 25 g/kg/day SGA babies had same growth velocity as AGA babies, but remained SGA Exclusive human milk-based diet with early and rapid advancement of fortification was associated with weight gain exceeding targeted standards and with length and HC growth meeting targeted standards Hair AB, et. al. Human milk feeding supports adequate growth in infants 1250 grams birth weight. BMC Research Notes.2013;6:459

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35 Suggested Guidelines for Feeding Enteral feeds should be initiated within the first hours of life (the earlier the better). Start day 1 TPN at appropriate volume for age immediately after birth. Colostrum should be used for mouth care. Place ml onto oral mucosa in buccal cavity for absorption by mucosa. Breast milk is preferred for feeds. Colostrum, if available, will be used for early feeds. Every effort should be made to encourage the mother to pump and provide breast milk. If maternal breast milk is not available, donor breast milk should be used for all infants less than 1500 grams. If breast milk is not available and donor breast milk is not an option, substitute with premature infant formula. Have never needed formula with good parent education. Gradually advance total volume of feeds to cc/kg/day if respiratory status allows. Fortify early with +6 fortifier. Total volume of feeds will be increased before additional fortification is recommended. Consider adding Prolact CR before increasing caloric density above +6. Remove PICC line when feeds at 120 ml/kg/day and glucose is stable

36 Sample Feeding Protocol Infants < 1250 grams or <29 weeks: Total day 1 fluid volume will be ml/kg/day inclusive of feeds and Day 1 TPN. Start feeds within hours at ml/kg/day, q 3 hrs. Use breast milk at 20 cal/oz (maternal or donor). Advance feeds and total fluids by ml/kg/day. Fortify with Prolact+6 when feeds reach 60 ml/kg/day feeds Add Prolact CR at 100 ml/kg/day if growth not optimal or on donor milk other than Prolact HM. When enteric feeds reach 120 ml/kg/day, TPN will no longer be used. After TPN, continue to advance enteric feeds by ml/kg/day to a goal of ml/kg/day. Increase to +8 if growth not meeting goals after 3 days of full fortified feeds.

37 Weaning Start wean at 34 0/7 weeks Day 1: 6 feeds Prolact+ fortified, 2 feeds bovine fortifier or formula (Q 3 hr feeds) Day 2: 4 feeds Prolact+, 4 feeds Bovine Day 3: 2 feeds Prolact+, 6 feeds bovine Day 4: All Bovine fortifier with Mother s milk or premature infant formula if mother has no breast milk

38 Excellent Growth with Similar Protocol at Samuelson Children s Hospital Average weight gain: 23 g/day Average growth velocity: 18 g/kg/day Average head circumference Increase: 0.86 cm/wk Average length Increase: 0.97 cm/wk Swerdfeger, Elliott. Presented at Region 4 Academic Pediatric Association Conf Charlottesville, VA

39 Optimizing Nutrition Length of Feeding Tubing? The longer the tubing, the more human milk fat that get stuck to it. If the calories are getting stuck in the tubing, the baby isn't getting them in his/her feeding. The syringe position (when the feeding is given via a pump)? Fat is a necessary nutrient. Fat rises to the top which means that the syringe tip facing up, will allow for maximal fat to be delivered to the patient. Are the feeds bolus or continuous? Continuous feeds allow for more fat sticking to the tubing and less fat getting to the baby. How often are feeding tubes changed? Frequent new tubes will give a greater new surface area for the fat to stick to which leads to loss of nutrition. All can contribute to poor weight gain!

40 Fortifier and Cream Improve Fat Delivery in Continuous Enteral Infant Feeding of Breast Milk Tabata M, et.al. Fortifier and Cream Improve Fat Delivery in Continuous Enteral Infant Feeding of Breast Milk. Nutrients. 2015; 7:

41 Optimizing Nutrition Bolus feeds best over slow pump flow rates or continuous feeds o Increased Fat loss with tubing (Kangaroo pump worse that syringe pump) o Prolact+H 2 MF and/or Prolact CR improve fat delivery even with continuous feeds Cream shown to shorten Length of Stay in g infants (not specifically studied yet in <750g group) Substantial calcium and phosphorus losses with continuous feeds, minimized in vitro with human milk based fortification (no direct CaPhos salt loss as in bovine fortified milk) Estimated calorie loss ranged between 3 kcal/kg/day to 25 kcal/kg/day depending on fortifier and feeding method

42 Questions?

43 References Bisquera JA, Cooper TR, Berseth CL. Impact of necrotizing enterocolitis on length of stay and hospital charges in very low birth weight infants. Pediatrics. 2002; 109: Sullivan S, et. al. An Exclusive Human Milk-Based Diet IS Associated with a Lower Rate of Necrotizing Enterocolitis that a Diet of Human Milk and Bovine Milk-Based Products. J Pediatr. 2010;156: Rogers SP, et.al. Continuous Feedings of Fortified Human Milk Lead to Nutrient Losses of Fat, Calcium and Phosphorous. Nutrients. 2010: 2: Viadyanathan G, Hay JW, Kim JH. Cost of necrotizing enterocolitis and cost-effectiveness of exclusively human milk based products in feeding extremely premature infants. Breastfeed Med. 2011; 6: 1-9. Neu J, Walker AW. Necrotizing Enterocolitis. N Engl J Med. 2011; 364: Ganapathy V, et.al. Costs of Necrotizing Enterocolitis and Cost-Effectiveness of Exclusively Human Milk- Based Products in Feeding Extremely Premature Infants. Breastfeeding Med.2012;7: Breastfeeding and the Use of Human Milk. AAP Policy Statement. Pediatrics. 2012;129(3):e827-e841. Bhatia, J. Human milk and the premature infant. Ann Nutr Metab. 2013; 62 (suppl. 3): Cristofalo EA, et.al. Randomized Trial of Exclusive Human Milk versus Preterm Formula Diets in Extremely Premature Infants. J Pediatr. 2013;163:

44 References Hair AB, et. al. Human milk feeding supports adequate growth in infants 1250 grams birth weight. BMC Research Notes.2013;6:459 Ganapathy V, et.al. Long term healthcare costs of infants who survived neonatal necrotizing enterocolitis: a retrospective longitudinal study among infants enrolled in Texas Medicaid. BMC Pediatrics. 2013;13:127 Patel AL, et. Al. Impact of Early Human Milk on Sepsis and Health-Care Costs in Very Low Birth Weight Infants. J Pernatol. 2013;33: National Center for Health Statistics. March of Dimes Peristatistics, Accessed September 29, Abrams SA, et. Al. Greater Mortality and Morbidity in Extremely Preterm Infants Fed a Diet containing Cow Milk Protein Products. Breastfeeding Medicine. 2014;9:1-5 Huston RK, et. al. Decreasing Necrotizing Enterocolitis and Gastrointestinal Bleeding in the Neonatal Intensive Care Unit The Role of Donor Human Milk and Exclusive Human Milk Diets in Infants <1500 g Birth Weight. ICAN: Infant, Child, & Adolescent Nutrition.2014;6(2): Zhou J, et. Al. Human Milk Feeding as a Protective Factor for Retinopathy of Prematurity: A Metaanalysis. Pediatrics. 2015;136(6):e1576-e1586.

45 References Tabata M, et.al. Fortifier and Cream Improve Fat Delivery in Continuous Enteral Infant Feeding of Breast Milk. Nutrients. 2015; 7: Assad M, Elliott MJ, Abraham JH. Decreased Cost and Improved Feeding Tolerance in VLBW Infants Fed an Exclusive Human Milk Diet. J Perinatol. 2016;36: Hair AB, et.al. Premature Infants 750 1,250 g Birth Weight Supplemented with a Novel Human Milk- Derived Cream Are Discharged Sooner. Breastfeeding Medicine. 2016;11(3): Hair AB, et.al. Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet. Breastfeed Med.2016:11(2):1-5.