Unique factors enhancing intellectual visual development
4 Short term benefits of human milk feedings for preterm infants
Shorter LOS less sepsis less necrotizing enterocolitis (NEC) less TPN cholestasis.
Both exclusive and partial human milk feedings (compared to formula) protect against NEC.
Improved host defenses from functional WBCs IgA nutrient enzyme activity lactoferrin lysozyme oligosaccharides.
Bioactive factors active peptides glycoproteinsare growth-promoting for specific cell types.
Trophic factors promote GI maturation and growth hormonal responses and probiotic gut colonization with non-pathogenic bacterial flora.
5 Effect of human milk feeding on morbidity hospital stay Schanler et al. Pediatrics 19991031150-57. B. Wt. 1000 g GA lt30 wks p lt 0.01 plt0.07 plt0.05 6 (No Transcript) 7 Longer term benefits
Neuro-developmental outcome IQ measurably improved in preterm infants fed human milk.
Human milk-fed LBW infants compared to formula-fed babies
improved cognitive function (5 points)
higher IQ scores (8 points) measured at 3 and 8 yr. age (adjusted for maternal education and SES)
Cognitive developmental benefits of breastfeeding increase with duration of breastfeeding.
Lucas Lancet 1992339261 8 Outcomes by quintiles of breastmilk intake in ELBW infants Vohr et al. Pediatrics 2006118e115. NICHD n775 EBM n 260 no EBM 800g 27 wks. Bayley II MDImental dev index PDI psychomotor dev index BRSbehavioral rating scale 9 Long term health benefits from breastfeeding
Lower incidence of otitis media URI infectious diarrhea UTI bacteremia meningitis
Reduced rates of
Sudden infant death syndrome (SIDS)
Ulcerative colitis and Crohns disease
Insulin-dependent (type I) diabetes type II diabetes
Allergic diseases and asthma
Lymphoma leukemia and Hodgkins disease
Reduction in overweight and obesity
10 Maternal benefits
Delayed return of fertility increased child spacing
Less lifetime blood loss (lactation amenorrhea)
Reduced risk of ovarian cancer
Lower rate of pre-menopausal breast cancer
4 reduction for every year breastfeeding
Reduced rate of spinal and hip fractures
Lower rate of metabolic syndrome (obesity type II diabetes hypertension)
Mothers Milk Bank at Austin http//www.mmbaustin. org
National Milk Bank http//www.nationalmilkbank.or g
Prolacta Bioscience http//www.prolacta.com
UKAMB http//www.ukamb.org
South Africa http//www.ithembalethu.org
18 Human milk banking in Brazil
Breastfeeding duration from 5.5 mos. (1989) to 10 mos. (1999).
In April 2001 Brazil had 182 Baby-Friendly Hospitals.
Banked human milk saved Brazils Ministry of Health 540 million/ year.
Network of 150 milk banks collects donated milk gt 218000 liters/ year (1999-2000) providing milk for 300000 pre-term infants.
6000 mail carriers trained in the Breastfeeding Friendly Postman Program.
Involving firefighters mail carriers in breastfeeding support roles allows the government to emphasize importance of breastfeeding to entire country.
Source http//www.infactcanada.ca
19 Internet access to human milk donation
Milkshare.birthingforlife.com
created to educate women about alternatives to receiving banked milk. an educational resource and connection point designed to give mothers who are unable to produce. milk some tools to explore private milk donation. MilkShare does not support the selling of breastmilk.
21 Land of milk money Breast-milk enterprise raises concerns among those who view collection and distribution as a philanthropic endeavor By Deborah EnsorSTAFF WRITER February 12 2006 LAURA EMBRY / Union-Tribune Machinery to process donated breast milk is tested and observed by (from left) Raymond Ortega Jose Maldonado and Armando Montoya at the Prolacta Bioscience facility in Monrovia. The company intends to sell its product to hospitals to feed low birth weight and critically ill babies. 22 Got breast milk Buyers are willing to payBut booming trade raises safety ethical questions By Marsha Austin - The Denver Post3/26/2006 You wont find it on any commodities exchange but there is a booming trade in mothers breast milk.The nations largest nonprofit milk banks distributed 745329 ounces last year double the amount in 2000 at a cost of 2.6 million.Prolacta Bioscience a for-profit company in August started marketing a breast-milk concentrate for 48 an ounce.And some mothers are selling their own milk on the Internet for 1 to 2.50 an ounce more than a third less than milk from the big banks.Since January one popular Web site has listed more than 100 human-milk advertisements.This is all going on with little regulation raising ethical and safety questions. 23 (No Transcript) 24 Clinical uses of donor human milk
Nutritional support
Prematurity
Failure to thrive
Malabsorption syndromes
Feeding intolerance
Preventative
NEC
Crohns disease
Colitis
Medical and therapeutic
Short gut syndrome (NEC)
Infectious diseases (AGE sepsis pneumonia)
Post-surgical gut healing (omphalocele gastroschisis bowel obstruction)
Immunological diseases (allergies IgA def)
Renal failure
Inborn errors of metabolism
JHL 200420(1)75-7. 25 Other clinical uses for donor human milk
Allergies
Formula intolerance
Adopted babies
Congenital anomalies
Maternal problems
Breast cancer
Adult treatment
Cancer
Immune deficiency
AIDS
Other GI diseases
Chronic diarrhea
Botulism
Hirschsprungs disease
Post-op therapy
Cardiac repair
Cleft palate repair
Transplantation
JHL 200420(1)75-7. 26 Donor Human Milk
60-70 of banked human milk goes to out-patients older infants children and occasionally adults.
HMBANA recommends highest priority for
Ill premature infants
Well premature infants
Infants lt 12 months with qualifying medical problems
Infants over 12 months with illnesses thought to be responsive to donor human milk.
27 Studies of clinical efficacy of donor human milk
Donor breast milk versus infant formula for preterm infants systematic review meta-analysis. Boyd CA Quigley MA Brocklehurst P. Arch Dis Child Fetal Neonatal Ed. 200792 F169.
Donor human milk versus formula for preventing NEC McGuire W Anthony M. Arch Dis Child Fetal Neo Ed. 200388F11.
Donor human milk for preterm infants Wight N.
J. Perinatol 2001211.
Breast milk and neonatal NEC Lucas Cole.
Lancet 19903361519.
28 Growth parameters infection related events among ELBW infants RCT donor human milk v. preterm formula. Schanler. Peds 2005 116(2) 400-406. 29 Better growth in premature infants managed with adjustable fortification of human milk Arslanoglu S Moro GE Ziegler EE. Adjustable fortification of human milk fed to preterm infants. J Perinatol 200626614. Italy n32 60 MM 40 donor BM. 30 Late onset sepsis in Norwegian cohort of ELBW infants. Ronnestad Pediatrics 2005115(3)269. 1999-2000 births n405 31 (No Transcript) 32 Regulation and oversight
Human Milk Banking Association of North America (HMBANA)
Centers for Disease Control Prevention (CDC)
Food Drug Administration (FDA)
State Departments of Health state laws
TX guidelines related to procurement processing and distribution of human milk
NY CA laws requiring banks to be licensed with state before distributing milk
33 HMBANA Donor Milk Banks 2008 San Jose CA Denver CO Indianapolis IN Iowa City IA Kalamazoo MI Raleigh NC Columbus OH Austin TX Ft. Worth TX Vancouver BC Newtonville MA 34 Cities with hospitals servedby HMBANA in 2007 In-patients only 35 HMBANA publications 2007 Guidelines for the Establishment and Operation of a Donor Human Milk Bank 40/copy 2006 Best Practice for Expressing Storing and Handling of Mothers Own Milk in Hospital and at Home 50/copy 2006 Starting a Donor Human Milk Bank A Practical Guide 25/copy www.hmbana.org 36 (No Transcript) 37 (No Transcript) 38 Mothers Milk Bank at Austin 39 Mothers Milk Bank at Austin Income in 1000 40 Mothers Milk Bank at Austin Expenses in 1000 Excludes capital expenses 41 Human milk banking - donor selection
Identification education of potential donors
good health
no medications or herbal supplements
nursing infant lt 1 year old
Review of donors medical health history
Exclusion criteria
Donor screening methods
Verbal written laboratory
Serological testing
HIV HTLV III HBV HCV syphilis /- TB
Costs 150 300/ donor
42 Donor exclusion criteria
Positive test for HIV HTLV HBV HCV syphilis
She or partner at risk behaviors for HIV
Use of illegal drugs
Smokes or uses tobacco products
Drinks more than two alcoholic drinks per day
Organ or tissue transplant or blood transfusion in last 12 months
Tattoo or body piercing in last 12 months
Traveled to UK for gt 3 months or Europe gt 5 months from 1980-1996
Same criteria as American Assoc. Blood Banks (AABB www.aabb.org)
Destroys bacteria viruses yet retains many immunological nutritional properties
56 C destroys HIV HTLV CMV
62.5 C destroys TB
46 (No Transcript) 47 (No Transcript) 48 Pasteurization of Human Milk 49 Donor milk processing
Pre-pasteurization bacteriological screening
screens donor technique
Heat processing
Post-pasteurization bacteriological testing
screens heat treatment procedure
no positive cultures are acceptable
93-99 are sterile
Chilling storage
No documented case of disease transmission through use of pasteurized donor human milk.
50 Frozen Pasteurized Human Milk Stored at - 20 C 51 Pre-pasteurization bacterial contamination MMBA 2002 52 Possible transmission of viruses through Human Milk (HM) Detected in HM Mother to child Disease transmission CMV HIV-1 AIDS HTLV-1 T cell lymphoma HBV _ _ HCV _ _ Rubella _ O West Nile O Adapted from Robert F. Pass MD 53 Factors influencing safety of donor human milk
Donor screening honesty
Medication /or herbal exposure
Potential infectious agents
Milk changes from storage preservation
Milk changes from heat treatment methods
Quality control of milk banking techniques
54 Donor milk distribution
Dispensed by prescription only
Cost varies 3.00 4.50 per ounce
Packaging labeling
Preterm donor milk
Donor mother delivered lt 36 weeks
Designated preterm for 4 weeks
Term donor milk
Infant born at greater than 36 weeks
55 Milk banks IRS income tax status
Not-for-profit (501c3)
Hospital-based or
Independent community- based
Business plans
Other funding - grants
Financials reports on-line
via IRS
HMBANA affiliation
Processing fee charged per oz donor milk
Both in out-patients served
For-profit
Different business model
Private venture capital (4 million)
National Milk Bank affiliation
Donor milk other products sold
Only in-patients served
56 Milk banks IRS Income tax status
Not-for-profit
Oversight
Medical advisory board
Board of Directors
Regulated by state laws
HMBANA guidelines
FDA CDC input
For-profit
Oversight
Medical advisory board
Board of Directors
FDA regulations
For food
For pharmaceuticals
Advertising
Marketing
Compensation to donors (breast pumps)
Money to hospitals
57 IRS Income tax status
Not-for-profit
Donor screening
Quality control
Pasteurization method
Holder
Cost of donor milk
3 - 4.50/oz
For-profit
Donor screening
Quality control
Pasteurization method
HTST
Cost of donor milk
30/oz (or 10/10ml)
www.mmbaustin.org www.prolacta.com 58 Prolacta donor screening quality control
Written verbal heath risk questionnaires
Physician statements RE mothers babys health
Donor serological testing (HIV HTLV HBV HCV RPR)
Donor milk drug testing
Donor tracking system
DNA fingerprinting (to ensure donor milk belongs to screened donor)
Cold chain delivery system data logging technology
PCR testing for infectious diseases on milk pools both pre post-pasteurization
Microbiological testing both pre post-pasteurization
59 Heat treatment methods used with human milk
Holder Pasteurization
62.5 ºC for 30 minutes
HTST (high temperature-short time)
72 ºC for 16 seconds
60 Effective RF HIV HCV HBV BVDV HCV (bovine viral diarrhea) PRV HBV (pseudo-rabies virus) PPV HPV (porcine parvovirus) RF reduction factors Terpstra Rechtman et al. Viral reduction with HTST. BF Med 2007227-33 61 Terpstra Rechtman et al. Antimicrobial and antiviral effect of HTST pasteurization applied to human milk. Breastfeeding Med 2007227-33 62 Milk treatment methods - effect on CMV milk components Hamprecht et al. Pediatr Res 200456(4) 529-535. 63 Components of human milk altered by freezing pasteurization J Human Lact 200117(2) 154. 64 Nutritional labeling of donor milk 65 Milkoscan FT-120 (Foss Electric) calibrated to human milk using standard USDA manual assays for carbohydrate protein and fat. (Carbohydrate-lactose AOAC 984.15 Protein N-Kjeldahl AOAC 991.20 Fat-Ether extraction AOAC 989.05) 66 Rivera Updegrove. Mothers Milk Bank at Austin. Variation of content of donor human milk. Presented AAP NCE 2004. 67 Rivera Updegrove. Mothers Milk Bank at Austin. Variation of content of donor human milk. Presented AAP NCE 2004. 68 Nutritional content of human milk Rev Panam Salud Publica 200416(3)199. 69 (No Transcript) 70 (No Transcript)
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