9/16/2015. Focus on Nutrition Infant Formulas Which Formula, and When? Clinical Advances in Pediatrics 2015 September 17, 2015.

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1 Focus on Nutrition Infant Formulas Which Formula, and When? Disclosure I have no financial disclosures Clinical Advances in Pediatrics 2015 September 17, 2015 Ruba Abdelhadi, MD, CNSC Director, Nutrition Services Programs The Children's Mercy Hospital Objectives To review the different formulas, milk protein based, soy protein based, partially hydrolyzed, extensively hydrolyzed, free amino acid formulas and their individual characteristic composition To review the evidence based guidelines and literature evidence regarding the indications for these formulas A new parent s nightmare A 3 week old infant has fussiness spits up with every feed but growing & developing normally no skin or respiratory abnormalities parents have already tried 4 different formulas A 5 week old breastfed infant has fussiness irritability & poor consolability is vomiting has atopic cheeks & visible hematochezia mom would like to discuss transitioning to formula A 6 month old continues effortless painless spit ups without fussiness parents have already tried 4 different formulas they would like to try the AR modified formula An 8 month old first born infant of an Amish family is not gaining weight family switched around cow s milk & goat s milk they are not comfortable with trying the formula you prescribed via the WIC office 3 4 Cow's milk formulas Standard formulas Whey-to-casein ratio 20:80 casein forms large curds on exposure to gastric acid slower gastric emptying than human milk (whey-tocasein ratio 70:30) Lactose is the predominant CHO fermentation in distal bowel facilitates lactobacillus proliferation Cow's milk formulas Standard formulas Docosahexaenoic acid (DHA) & arachidonic acid (ARA) LCPUFAs were added 2002 Studies correlated these to improved visual & neuro-developmental outcomes Vegetable oil source mimics the ratios of saturated, monounsaturated, polyunsaturated fatty acids in human milk essential FAs Hoffman DR, Boettcher JA, Diersen-Schade DA. Toward optimizing vision and cognition in term infants by dietary docosahexaenoic and arachidonic acid supplementation: a review of randomized controlled trials. Prostaglandins Leuko Essent Fatty Acids. 2009;81: Hoffman DR, Boettcher JA, Diersen-Schade DA. Toward optimizing vision and cognition in term infants by dietary docosahexaenoic and arachidonic acid supplementation: a review of randomized controlled trials. Prostaglandins Leuko Essent Fatty Acids. 2009;81:

2 Safe in term infants evidence for adequate growth rates and bone mineralization Higher protein content, L-Meth, Tau, L-Car to improve biologic value Nitrogen load not ideal in renal disease Lactose-free CHO source is glucose polymers from corn syrup solids or malto-dextrin The only clear clinical indications galactosemia congenital lactase deficiency Option for vegan families who prefer to avoid consuming animal derived products Not indicated in transient lactase deficiency & post-viral enteropathy minimal effect on the duration of diarrhea Soy formulas contain 20% higher Ca Phos Zn Fe Fiber oligosaccharides & soy phytates have a high affinity for Ca Phos Zn Fe leading to diminished bioavailability Fat source vegetable oils & supplemented DHA & ARA LCPUFAs AAP Pediatric Nutrition Handbook, 2004 Preterm infants soy-based formulas cannot meet the high Ca & Phos needs to match intra-uterine accretion values Aluminum content competes with Ca absorption High concentrations of phyto-estrogens & isoflavones resemble 17 estradiol bind to estrogen receptors potential negative effects on estrogen-related functions in animal studies conflicting results Cow s Milk versus Soy protein-based formulas To date no definite evidence is seen of increased feminization, hypospadias, or major changes in menstrual flow among people who consumed soy formula as infants Phytates may decrease uptake of exogenous thyroid hormone in infants with congenital hypothyroidism. Infants fed soy formula have a prolonged increase in TSH A retrospective follow-up study showed no reproductive or estrogen-related adverse effects in adults who had been fed soy formula exclusively as infants Strom BL, Schinnar R, Ziegler EE, et al. Exposure to soy-based formula in infancy and endocrinological and reproductive outcomes in young adulthood. JAMA.2001;286: Strom BL, Schinnar R, Ziegler EE, et al. Exposure to soy-based formula in infancy and endocrinological and reproductive outcomes in young adulthood. JAMA.2001;286: Evidence-based indications for their use are limited No benefit in infantile colic Nevertheless 1 out of every 5 infants in clinic is on soy formula ESPGHAN recommends that use of soy formulas be limited to infants older than 6 months of age who have signs consistent with IgE-mediated allergy after successful clinical challenge Clinical clues to IgE-mediated reaction immediate within 20 minutes of contact hives itching vomiting ESPGHAN Committee on Nutrition, Agostoni C, Axelsson I, Goulet O, et al. Soy protein infant formulae and followon formulae: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2006;42: No indication in atopic diseases no indication in non-ige allergies to cow milk protein (CMPI) Clinical clues to non-ige-mediated reaction spit ups vomiting colic fussiness diarrhea hematochezia blood and skin tests neg Non-IgE mediated allergic enteropathy or enterocolitis due to CMPI have 30% to 64% rate of cross-reaction to soy protein However only about 10% of those with IgE mediated CMPA are sensitized to soy ESPGHAN Committee on Nutrition, Agostoni C, Axelsson I, Goulet O, et al. Soy protein infant formulae and followon formulae: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2006;42:

3 As 25-60% of infants are sensitive to soy protein Soy formulas are not recommended for Non-IgE cow s milk protein intolerance Normal Colon Hypoallergenic Infant Formulas. AAP Committee on Nutrition, 2000 Eosinophilic Colitis Sep-15 M. Miqdady, M.D 14 Cow s Milk versus Soy protein-based formulas In studies of infants with atopic dermatitis, soy allergy was present in approximately 5% of infants The incidence of eczema among infants at risk for atopic disease was not reduced when breastfeeding was supplemented with soy formula compared with cow milk formula Cow s Milk versus Soy protein-based formulas SOY BASED FORMULA NOT ACCEPTABLE FOR preterm infants LBW infants Infants with renal impairment Partially hydrolyzed formulas phf Partially hydrolyzed whey protein marketed with improved digestibility reduced oligo-peptides have molecular weight < 5kd Reduced lactose content in favor of glucose polymers Per AAP guidelines phfs are NOT hypo-allergenic Peptides containing as few as three amino acids can still induce T- cell activity in vitro to be labeled as hypoallergenic the AAP guidelines state that formulas must demonstrate that they do not provoke reactions in 90% of infants or children with confirmed cow milk allergy with 95% confidence when given in prospective randomized, double-blind, placebo-controlled trials Extensively hydrolyzed formulas ehf Casein is heat-treated & enzymatically hydrolyzed peptides molecular weight <3kd Per AAP guidelines yes hypo-allergenic Primary CHO source glucose polymers Fat vegetable oils Pregestimil relatively higher MCT content + the LC essential FAs MCTs are absorbed directly into the portal vascular system do not require bile acids for micellar solubilization Malabsorption syndromes SBS Pancreatic Insufficiency and PICF biliary atresia ileal resection 3

4 Free amino acid formulas Protein Hydrolyzed formulas Free amino acid-based formulas approved by the FDA Neocate Elecare Nutramigen AA phf ehf CHO source is glucose polymers USA Partial hydrolyzate Hypoallergenic Oil blend includes LCT & MCT Europe HA hypoallergenic Semi-elemental Allergy Allergenicity Allergenicity Tolerance Tolerogenicity NO Tolerogenicity Prevention Treatment Partially hydrolyzed formulas phf Meta-Analysis on 1 allergy prevention of atopic disease in high risk infants Meta-analysis of 15 prospective, controlled trials on phf Significant prophylactic effect of phf on development of atopic symptoms at 60 mo of age Baumgartner M et al, Nutr Res % allergic manifestations Cumulative incidence Regular formula phf Breastfed Age months Short-term Long-term Baumgartner M et al, Nutr Res Extensively hydrolyzed ehf versus partially hydrolyzed phf Meta-analysis of studies of atopic infants who were fed phf found about a 50% reduced risk for atopic dermatitis at 1 year of age and 36% reduction at 3 years Literature review infants with proven CMPA should receive ehfs German study phf AND ehf BOTH reduce significantly atopic dermatitis Extensively hydrolyzed ehf versus partially hydrolyzed phf Non-IgE mediated entero-colitis with chronic diarrhea & growth failure severe eczema ehf-non-responders consider amino acid-based formulas than hydrolyzed formulas Infant colic a percentage of infants respond to HFs a 1-2 weeks trial on hydrolyzed formulas can be recommended Alexander DD, Cabana MD. Partially hydrolyzed 100% whey protein infant formula and reduced risk of atopic dermatitis: a meta-analysis. J Pediatr Gastroenterol Nutr. 2010;50: Hill DJ, Murch SH, Rafferty K, Wallis P, Green CJ. The efficacy of amino acid-based formulas in relieving the symptoms of cow s milk allergy: a systematic review. Clin Exp Allergy. 2007;37: Von Berg et al, J Allergy Clin Immunol Alexander DD, Cabana MD. Partially hydrolyzed 100% whey protein infant formula and reduced risk of atopic dermatitis: a meta-analysis. J Pediatr Gastroenterol Nutr. 2010;50: Hill DJ, Murch SH, Rafferty K, Wallis P, Green CJ. The efficacy of amino acid-based formulas in relieving the symptoms of cow s milk allergy: a systematic review. Clin Exp Allergy. 2007;37:

5 Extensively hydrolyzed ehf versus partially hydrolyzed phf AAP guidelines for infants at high risk of developing atopic disease who are not breastfed exclusively for 4 to 6 months or are formula-fed, there is evidence that atopic dermatitis may be delayed or prevented by the use of ehf or phf compared with cow milk-based formula but phfs are not as effective as ehfs in atopic diseases Free AA formulas among the Extensively hydrolyzed ehf Extreme protein allergy Severe malabsorption disorders ehf non-responders Other indications not based on RCT experts recommendations critically ill poor perfusion to intestine prolonged NPO status Greer FR, Sicherer SH, Burks AW. Effects of early nutritional interventions on the development of atopic disease in infants and children: the role of maternal dietary restriction, breastfeeding, timing of introduction of complementary foods, and hydrolyzed formulas. Pediatrics. 2008;121: Research evidence Based on strong research evidence, partially or extensively hydrolyzed formulas are effective in preventing or delaying development of atopic dermatitis in high-risk infants Review of published literature The most effective dietary measure for the prevention of allergic diseases is exclusive breast-feeding for 4-6 mo (even in high-risk patients) AAP Guidelines, Pediatrics June 2008 Muraro A et al, Pediatr Allergy Immunol 2004 Middle East Consensus Statement, PGHN 2014 Greer FR, Sicherer SH, Burks AW. Effects of early nutritional interventions on the development of atopic disease in infants and children: the role of maternal dietary restriction, breastfeeding, timing of introduction of complementary foods, and hydrolyzed formulas. Pediatrics. 2008;121: Prevention of CMPA Greer et al, Pediatrics 2008 Host, A., et al., Pediatric allergy and immunology 2008 Boyce JA et al. J Allergy Clin Immunol

6 but what about Goat milk?! Infants with CMPI goat milk is an inappropriate substitute Only a 1/5 th showed adequate immediate and late oral tolerance to goat milk with neg results of immunological tests The use of goat's milk cannot be recommended to patients with cow's milk allergy without investigation of possible tolerance by a specialist For the minority that tolerate goat's protein goat's milk can be a substitute no sooner than 2 years of age Bellioni-Businco B et al, J Allergy Clin Immunol Martorell, et al, An Pediatr (Barc) Infante Pina, An Pediatr (Barc) Preterm infant formulas Preterm formulas have a higher caloric density than standard formulas (24 kcal/oz) Supplemental taurine whey-predominant protein supports growth and body composition changes comparable to intrauterine standards Fat & CHO compositions are designed to overcome nutrient losses from low concentrations of lipase, bile salts, and intestinal lactase MCT 50% of total fat supplemental DHA & ARA 33 Preterm infant formulas CHO source glucose polymers and lactose lactose has beneficial effects on Ca absorption & as a prebiotic High Ca Phos vit A vit D Should be transitioned from preterm and term formulas after discharge or at 1,800-2,000 gm or ~ 34 weeks GA Modified Cow milk-based formulas Thickened formulas Meta-analysis reviewed 14 randomized, controlled trials on carobbean gum, cornstarch, rice starch, cereal, and soy fiber improved regurgitation reduced vomiting, crying irritability BUT ph probe indices were not significantly improved, with the exception of a shorter duration of the longest episode of ph lower than 4 thickened formulas may reduce non-acid reflux Horvath A, Dziechciarz P, Szajewska H. The effect of thickened-feed interventions on gastroesophageal reflux in infants: systematic review and meta-analysis of randomized, controlled trials. Pediatrics. 2008;122;e1268 e1277 6

7 Modified Cow milk-based formulas Thickened formulas Pre-thickened formulas are not superior to formulas thickened later with corn starch or rice cereal Meta-analysis reported increased coughing and diarrhea but no reported malabsorption of macro- and micronutrients Research evidence Based on strong research evidence, thickened formulas reduce the number of episodes of vomiting, regurgitation, and signs of GERD such as irritability and crying Horvath A, Dziechciarz P, Szajewska H. The effect of thickened-feed interventions on gastroesophageal reflux in infants: systematic review and meta-analysis of randomized, controlled trials. Pediatrics. 2008;122;e1268 e1277 Standard Formula Galactosemia Primary lactase deficiency IgE-mediated reaction to standard formula Soy Formula Extensively hydrolyzed formula non- Responder Amino acid based Human milk CMPI Atopy Non-IgE-mediated reaction to milk protein Extensively hydrolyzed Malabsorption Pancreatic Insuff CF Biliary Atresia Short Bowel High MCT containing Regurgitation Cough Thickened formulas Prematurity Premature infant formula A new parent s nightmare A 3 week old infant has fussiness spits up with every feed but growing & developing normally no skin or respiratory abnormalities parents have already tried 4 different formulas A 5 week old breastfed infant has fussiness irritability & poor consolability is vomiting has atopic cheeks & visible hematochezia mom would like to discuss transitioning to formula A 6 month old continues effortless painless spit ups without fussiness parents have already tried 4 different formulas they would like to try the AR modified formula An 8 month old first born infant of an Amish family is not gaining weight family switched around cow s milk & goat s milk they are not comfortable with trying the formula you prescribed via the WIC office