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Fortification of breast milk, Why? When? With What?

Fortification of breast milk, Why? When? With What?. Keith J Barrington CHU Ste Justine Montréal. Conflict of Interest. I have no relevant financial relationships to disclose or conflicts of interest to resolve. I will not discuss any unapproved or off-label, experimental or

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Fortification of breast milk, Why? When? With What?

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  1. Fortification of breast milk, Why? When? With What? Keith J Barrington CHU Ste Justine Montréal

  2. Conflict of Interest • I have no relevant financial relationships to disclose or conflicts of • interest to resolve. • I will not discuss any unapproved or off-label, experimental or • investigational use of a product, drug or device.

  3. Breast is best, but it’s not good enough • The mixed message thatwegive to parents (mothers) • Advantages of breastmilk, are theyproven in the preterm? • Advantages of maternalbreastmik, are they certain? • Nutritionalrequirements to achieve good growth (whatisthat?) • Achievingthoserequirements

  4. “Breast is best, but it’s not good enough” • The mixed message thatwegive to parents (mothers), try to avoidthat implication • Advantages of breastmilk, are theyproven in the preterm? • Clearly, yes • Advantages of maternalbreastmik, are they certain? • As certain as we can be • Nutritionalrequirements to achieve good growth (whatisthat?) • Good growthis not justgettingheavier, but getting longer, growing the brain, and withouttoxicity • Achievingthoserequirements • How to do sowithmaternalmilk as the priority

  5. Nutritional requirements of the preterm infant, enteral • Energy : At least 120 kcal/kg/d • Protein : 4 (-4.5) g/kg/d • Calcium : 120 (-140) mg/kg/d • Phosphorus : 60 (-90) mg/kg/d

  6. Stoltz Sjostrom E, et al. Intake and macronutrient content of human milk given to extremely preterm infants. Journal of human lactation. 2014;30(4):442-9.

  7. Averagesupply of pretermbreastmilk at 200 mL/kg/d, by 6 weeks of age • Energy 140 kcal/kg/d + • Protein 2.8 g/kg/d – (changes over time) • Calcium 60 mg/kg/d -- • Phosphorus 12 mg/kg/d ----

  8. Achievingrecommendedintakes • Without fortifier: • Possible for calories • Possible for protein in the first week if baby tolerating full feeds at high volumes • Deficient for calcium, • Grosslydeficient for phosphorus

  9. Whatgrowthshouldwebeaiming for? • Tradition- Intra-uterinegrowthcurveswith good bonemineralization • Newer- Aim for weight, length, and headcircumference at 44 weeksthat the infant would have had if remained in utero with a wellfunctioning placenta • Landau-Crangle E, et al. Individualized Postnatal Growth Trajectories for Preterm Infants. JPEN Journal of parenteral and enteral nutrition. 2018;42(6):1084-92.

  10. GrowthCalculator.org

  11. Adding fortifiers • All derived from cows’ milk until recently • Not identical • Powders/Liquids • Different sources of calories and protein concentrations • Differing pH and other details of composition

  12. Whatis the evidence about efficacy and safety? • Randomized trials of fortification vs no fortification with Bovine ProteinFortifiers • Not isoenergetic/isoproteinic • Not blinded • Growthbetter (weight and headcircumference) • No evidence of adverse impacts, specifically no evidence of increase in NEC or other GI complications • Confidence intervalsrelativelywide

  13. Systematicreviews • Comparing no fortifier to a multicomponent fortifier • Cochrane review • Onlypowderedfortifiersstudied • Most studiespre 2000 • Most studiesverysmall

  14. Weight gain

  15. Head Growth

  16. Necrotising Enterocolitis

  17. Powders vs Liquids? • Very difficult to sterilize a powder • Liquidfortifiersdilute the quantity of breastmilkreceived • Are thereprovendifferences in clinical impact? • Kim JH, et al. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. JPGEN. 2015;61(6):665-71. • Liquid vs powder (n=129). New liquid fortifier with more protein, length and weight gain improved with liquid. No difference in morbidity

  18. Powders vs Liquids? • Many US centers switched to liquids, after reports of contamination of somebatches of powder, withCronobacteriasakasakii, and CDC recommendations • Most Canadian centers still use powders, want to give as muchbreastmilk as possible, whileachievinggrowth goals. • Many ELBW needincreased fortification to stay on growthcurves, if usingliquidfortifiers, evenlessmaternalbreastmilkgiven. • May give more fortifier thanbreastmilk

  19. Human vs Bovine (or Donkey) • Human milk (fortified) as a supplement for insufficientmaternalsupplycompared to artifical formula • Human based fortifier added to mother’smilkcompared to bovine based fortifier • Human based fortifier added to donormilkcompared to bovine based fortifier • Bertino E, et al. A Novel Donkey Milk-derived Human Milk Fortifier in FeedingPreterm Infants: A RandomizedControlled Trial. Journal of pediatricgastroenterology and nutrition. 2019;68(1):116-23.

  20. Human milk as a supplementcf Formula • Moderately good evidencesupplementationwithfortifiedhumandonormilkratherthan formula leads to • lowerweight gain, • lower longitudinal growth, • less gain in headcircumference • Incidence of Necrotising Enterocolitis Decreased by donor BF • Relative riskwith formula 1.9 (95% CI : 1.23, 2.85) • Quigley M, et al. Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane database of systematic reviews (Online). 2018;6:CD002971. • Little evidence of impact on sepsis

  21. More recent data • Trang S, et al. Cost-Effectiveness of Supplemental Donor Milk Versus Formula for Very Low Birth Weight Infants. Pediatrics. 2018;141(3). • Randomized 363 VLBW, mothersintending to breastfeed, supplementswitheitherdonor BM or formula, all BM fortifiedwith bovine proteinbased fortifier (powder) • NEC (grade ≥1) 11% with formula supplements, 4% withdonor BM • NEC (grade ≥2) 6.6% vs 1.7% (n=12 vs 2)

  22. “Exclusive Human Milk Diet” • Cristofalo EA, et al. Randomized Trial of Exclusive Human Milk versus Preterm Formula Diets in Extremely Premature Infants. The Journal of pediatrics. 2013. • Donor BM with human-milk-based fortifier was compared to preterm formula. Small study (n=53) very high frequency of NEC with formula (21%, n=5), lower frequency with donor BM (3%, n=1). • Sullivan S, et al. An Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of Necrotizing Enterocolitis than a Diet of Human Milk and Bovine Milk-Based Products. The Journal of pediatrics. 2010;156(4):562-7.e1. • 3 group trial (n=207) • Maternal BM (supplements of donor BM as required) and fortification with human-milk-based fortifier starting at 40 mL/kg/d, or at 100 mL/kg/d. • 3rd group : maternal BM (supplements of artificial formula as required) BM fortified with bovine fortifier introduced at 100 mL/kg/d. • Higher frequency of NEC in the formula supplements/bovine fortifier group, who received on average 20% of their milk as artificial formula.

  23. The advantages of the “Exclusive Human Milk Diet” have been suggested only in comparison to • 1. Preterm formula • 2. Supplementing maternal BM with formula (and fortifying with bovine protein based fortifier) • What about supplementing maternal BM with donor BM, and fortifying both with bovine based fortifier? • Commonest recipe in Canada

  24. Human milk fortifier (or bovine) to fortifymaternalbreastmilk • O'Connor DL, et al. Nutrientenrichment of humanmilkwithhuman and bovine milk-basedfortifiers for infants bornweighing <1250 g: a randomizedclinical trial. Am J Clin Nutr. 2018;108(1):108-16. • Randomized 127 VLBW infants • All receivedmaternal BM, wheninsufficient, donor BM • Comparedhumanmilkbased fortifier to bovine based fortifier (powdercontaining non-hydrolyzed bovine proteins) • No differences in feedingtolerance, or NEC (3 per group : stage 2)

  25. P<0.05 P=NS

  26. Individualized fortification? • Breastmilkisvery variable, and growth can beaffected by variations in calorie and protein content • Individualized fortification is an attractive option • BUT : • Breastmilk varies withinmothers, by day, by time, betweenforemilk and hindmilk • Effective individualized fortification-labour intensive

  27. Individualized fortification? • Trials of routine individualized fortification have shownlittle impact • McLeod G, et al. Comparing different methods of human breast milk fortification: a randomised controlled trial. Br J Nutr. 2016;115(3):431-9. • Only 40 babies included, no impact on growth. Required 1870 analyses. • Arslanoglu S, et al. Adjustable fortification of human milk fed to preterm infants: does it make a difference? J Perinatol. 2006;26(10):614-21. • Only 32 babies included, individualized group grewbetter, received more protein • Most pretermsgrowwellwith routine fortification, and routine increases in fortifier in case of problems • E.G. start with ‘24 calorie’ for maternal BM, or ‘26 calorie’ for donor BM. Concentrate on nutrition eachday, increase fortification if anygrowthfaltering • Trials of individualized fortification onlyincluding babies withgrowthproblems not available.

  28. Fortification of donormilk • Higher protein content of preterm delivered mothers’ milk - many centers routinely start fortification of donor milk with higher concentrations of fortifier • We start with 6 sachets per 100mL for donor milk • compared to 4 sachets per 100 mL for maternal milk. • We call this “donor milk at 26kcal, and maternal milk at 24 kcal”

  29. When to start? • Many centers start fortification aftersubstantialenteralfeedingtoleranceachieved, or at full feeds • Some start earlier, we start at 25 mL total per day • 3 observationalstudies, no adverse impacts • Prospective controlled data? • 2 small trials, larger n=100, RCT of fortification starting at 20 mL/kg/d or 100 mL/kg/d. • Shah SD, et al. Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial. The Journal of pediatrics. 2016;174:126-31 e1. • No adverse effects, better nutrition with earlier fortification

  30. Lapointe M, et al. Preventing postnatal growth restriction in infants with birthweight less than 1300 g. Acta Paediatr. 2016;105(2):e54-9.

  31. When to start? • Transitioningfrom TPN to enteralfeeds, • Low calorie, protein, and mineraldensity of EBM can initiallybeaddressed by adjustingintravenousintakes. • As feedsprogress : progressively more difficult/impossible

  32. Summary of the data • Amongverypreterm or verylowbirthweight infants : • Growth and bonemineralizationapproachingdesired standards can onlybeachieved by fortifying BM • Commercial bovine or humanmulticomponentfortifers have become the standard of care • Desiredgrowth can beachievedwithmaternal BM and fortification, or donor BM and fortification, if enough attention paid to growth • Donor BM has lessprotein (and sligtlyfewer calories) thanpretermmaternal BM, for a few weeks, and requireshighersupplementation

  33. Summary of Data • Supplementinginsufficientmaternal BM with formula increases NEC compared to donor BM • (Older and recentstudies, moderate to good quality data) • Multicomponent fortification not shown to affect NEC compared to no fortification • (poor to moderatequality data, wide confidence intervals) • Multicomponent fortification from different sources not shown to have impact on NEC, • (moderatequality data, wide confidence intervals)

  34. Summary of Data • Individualized fortification using BM analysis not shown to improveclinically important outcomescompared to adjustmentaccording to growth • (poorquality data, smallstudies, wide confidence intervals) • Early introduction of fortifiers not shown to adversely impact clinicaloutcomes or complications compared to >100 mL/kg/d • (poorquality data)

  35. Evidencebased fortification protocol • For infants at risk of NEC: • Promote maternalbreastmilk as much as possible, early expression, lactation consultants, pumpsfreelyavailableeverywhere… • When MBM insufficient, always use donor BM, untilrisk of NEC passed (34 weeks?) • Fortify as soon as TPN can not meetrequirements of the infant (± 50 mL/kg/d) • Standard fortification at higher dose for donor BM • Use powder or liquid fortifier • Use bovine or human-based fortifier • Increase fortification if growth < target for 2 wk, at ≥ 160 mL/kg/d re-assessfrequently

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