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Growth and Health Outcomes in Donor Human Milk Fed VLBW
Infants:Results from the DoMINO RCT
Deborah L O’Connor and Sharon Unger on behalf of the GTA DoMINO Feeding Group
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Disclosure
• Drs. O’Connor and Unger serve in leadership roles at the Rogers Hixon Ontario Human Donor Milk Bank
• They lead a research program
with the aim to optimize use of human milk for Preterm Infants
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Objectives 1. Review the most current systematic
review examining the efficacy and safety of donor human milk compared to preterm formula as a supplement.
2. Present growth, morbidity and neurodevelopment results from the DoMINO RCT conducted in the Greater Toronto and Hamilton area in Canada.
3. Future directions for human milk research.
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Own Mother’s Milk
Own Mother’s Milk is the most appropriate source of nutrition for all infants including preterm infants:
• Well tolerated
• Associated with a reduction in late onset sepsis and NEC
• Associated with a reduction in non-specific gastroenteritis, severe lower respiratory tract infections, atopic dermatitis, asthma (young children), obesity, type 1 and 2 diabetes, childhood leukemia and sudden infant death syndrome.
• Duration and exclusivity of own mother’s milk feeding associated with superior neurocognitive development
Kim JH and Unger S. CPS Position Statement on Milk Banking. Paediatr Child Health 2010;15(9):595-8; U.S. Department of Health and Human Services. The Surgeon General’s Call to Action to Support Breastfeeding. Washington, DC, 2011
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Effect of Breast Milk Feeding on Neurodevelopment*
Outcome Parameter Estimate (For each 10 ml/kg/d
HM intake)
P-value
Cognitive Score (MDI) 0.53 0.0002
Motor Score (PDI)
0.63 <0.0001
Behavioural Rating Scale (BRS)
0.82 0.0025
Vohr et al Pediatrics 2006;118(1):e115-23; Vohr et al Pediatrics 2007;120(4):e 953-9
*Statistically controlled for demographic and clinical confounders
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So why not just feed mother’s own milk?
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Most Mothers of Very Preterm Infants are Unable to Provide a
Sufficient Volume of Milk
• Immaturity of the mammary secretory cell • Mother may be ill • Stress • Mother and Infant may be separated • Mothers are pump-dependent
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Processing Donor Milk
Freezing, storage, and transport
Thawing and Bacterial culture
Batching
Pasteurization
Culture of batch
Milk analysis
Freezing
Courier to institution
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Pasteurization Process Impacts the Nutritional Composition of Human Milk
• Stage during lactation when milk is collected • Freezing and thawing • Heat Treatment • Container Changes • Feeding Tubes
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Bioactive Components in Human Milk
Ewaschuk JB et al Appl Physiol Nutr Metab 36:175-182, 2011
Adiponectin Gonadotropin Mucins α-Lactoglobulin Glutathione peroxidase Ν-Acetyl-glucosamine Antisecretory lectins Granulocyte-colony stimulating factor Nucleotide-hydrolyzing antibodies α-Tocopherol GRP Neurotensin Ascorbate Haptocorrin Neutrophils β-Carotene Hepatocyte growth factor NGF B-cells Human-chorionic gonadotropin Nucleotides β-Defensin-1 Hypothalamus-related hormones Oligosaccharides Bifidogenic peptides (hLACFR-la) IFN-γ Osteoprotegerin Bididus factor IGF-1 Peptide YY Bombesin IGF-11 Platelet activating factor acetylhydrolase Catalase IL-1 receptor agonist Prebiotics Complement (C3, C4) IL-1b Prolactin Complement receptors (CF2, CD21) IL-2, -4, -5, -6, -8, -10, -12, -13, -16, -18 Protease inhibitors Cortisol Insulin RANTES Cysteine κ-Casein sCD14 EGF, HB-EGF Lactadherin Somatostatin Erythropoeitin Lactoferrin Substance P Estrogen, progesterone Lactoperoxidase T-cells Fibroblast growth factor LCFA-DHA, AA TGF-α Free secretory protein Leptin TGF-β Gangliosides Leukocytes Thyroid hormones Gastrin Lysozyme TLRs Ghrelin Macrophages TNF-α GIP MCFA Vasoactive intestinal peptide MCP-1
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Effect of Holder Pasteurization on Breastmilk Components
O’Connor DL Curr Opin Clin Nutr Metab Care 18:269-275, 2015.
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Important Points About the Systematic Review
• Study Selection criteria Randomized or quasi-randomized studies included 9 trials included: Raiha 1976; Davies 1977; Schultz 1980; Gross
1983; Tyson 1983; Lucas 1984a; Lucas 1984b; Schanler 2005; Cristofalo 2013
• Characteristics of randomized subjects 1070 infants; Most <1800 g and 32 weeks gestational age
(clinically stable) Most trials excluded SGA infants
• Enteral feeds 4 trials compared term formula vs donor milk 5 trials compared preterm formula vs donor milk Only the two most recent trials used nutrient fortification
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Formula versus Donor Milk for Feeding Preterm or Low Birth Weight Infants: NEC
Cochrane Database of Systematic Reviews 22 APR 2014 DOI: 10.1002/14651858.CD002971.pub3 http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002971.pub3/full#CD002971-fig-0006
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Cochrane Database of Systematic Reviews 22 APR 2014 DOI: 10.1002/14651858.CD002971.pub3 http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002971.pub3/full#CD002971-fig-00122
Formula versus Donor Milk for Feeding Preterm or Low Birth Weight Infants:
Feeding Intolerance
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Cochrane Database of Systematic Reviews 22 APR 2014 DOI: 10.1002/14651858.CD002971.pub3 http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002971.pub3/full#CD002971-fig-0003
Formula versus Donor Milk for Feeding Preterm or Low Birth Weight Infants:
Weight Gain
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Cochrane Database of Systematic Reviews 22 APR 2014 DOI: 10.1002/14651858.CD002971.pub3 http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002971.pub3/full#CD002971-fig-0004
Formula versus Donor Milk for Feeding Preterm or Low Birth Weight Infants:
Length Gain
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Cochrane Database of Systematic Reviews 22 APR 2014 DOI: 10.1002/14651858.CD002971.pub3 http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002971.pub3/full#CD002971-fig-0005
Formula versus Donor Milk for Feeding Preterm or Low Birth Weight Infants:
Head Circumference Gain
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Potential Risk of Donor Milk as a Supplement: Cochrane Review
Mean rate of weight gain was <15 g/kg/d in 6 of 8 trials for infants fed donor milk
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Distribution of Cases of NEC according to GA and Postmenstrual age (PMA) in the Study Cohort
Yee W H et al. Pediatrics 2012;129:e298-e304
©2012 by American Academy of Pediatrics
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Authors’ Conclusions • Many of the trials very old; more mixed feeding in current
NICUs; only two trials used nutrient-enriched human milk
Applicability to current practice
If you start adding nutrients to donor milk to correct growth will you negatively impact NEC-protection?
• High risk preterm infants excluded from many studies—i.e. SGA infants
• Future studies should ensure caregivers and assessors are blind to intervention
• Data on long-term outcomes lacking
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Donor Milk for Improved Neurodevelopmental Outcomes
DoMINO ISRCTN35317141; Registered 08/2010
Unger S, Gibbins S, Zupancic J, O’Connor DL: DoMINO: BMC Pediatrics 14:123, 2014
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What Will Be Our Primary Outcome Measure?
• Sample size required to examine NEC made RCT not feasible
• Neurodevelopment might be more appropriate Associated with dose of own mother’s milk-fed
(Vohr et al Pediatrics 2006;118[1]:e115-23; Vohr et al Pediatrics 2007;120[4]:e 953-9)
Associated with early growth and nutrition (Ehrenkranz RA et al 2006; Pediatrics 117[4]:1253-1260)
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Hypotheses In VLBW infants, when mothers’ own milk is unavailable, provision of pasteurized donor human milk compared to preterm formula during initial hospitalization will: • improve neurocognitive development at 18-24
months CA • reduce neonatal mortality and morbidity • support growth • Produce a gut microbial community composition
more like the exclusively mother’s own milk fed infant
• show an acceptable cost effectiveness from a societal perspective?
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Study Design
• Multi-centered double-blinded RCT 4 recruiting centres (Level III)
Total of 18 hospitals participating
• Infants randomized within 96 hr of birth using a 3rd party service
• Infants continue to receive study feedings after transfer to a participating Level II
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Inclusion/Exclusion
Inclusion • <1500 g
Exclusion • Severe congenital or chromosomal anomlies that
may contribute to poor neurodevelopment • Reasonable potential infant would be transferred
to a NICU where we did not have ethics approval
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Milk Preparation Room
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Details of Donor Milk
• Mother’s Milk Bank of Ohio Milk expressed in the 1st 3 months
postpartum
• Back-up: Calgary Mother’s Milk Bank • Once donor milk was fortified, a protein
modular was added (0.4 g/dl)
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Feeding Guidelines
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Rouge Valley Health System
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Frequency and Duration of Follow-up
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Subject Disposition
Current participants (n=316)
Deaths (n=37)
*Target: 363 randomized infants
Infants Approached to Participate (n=840)
Declined (n=477)
Infants Randomized (n=363)
Withdrawn from feeding intervention but consent to follow
outcome (n=34)
Withdrawals from the study (n=10)
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Baseline Characteristics Donor Milk
(n=181) Preterm Formula
(n=182) P-value Sex, n (%) NS
Female 80 (44.2) 88 (48.4) Male 101 (55.8) 94 (51.6)
Birth weight, g, mean + SD 995+273 996+272 NS Birth Size, n (%) NS
Singleton 121 (66.9) 113 (62.1) Multiple 60 (33.1) 69 (37.9)
Small for gestational age, n (%) 21 (11.6) 24 (13.2) NS Apgar score at 5 min, mean + SD 6.9+2.3 7.0+2.4 NS Maternal Age, yr, 31.4+5.9 32.6+6.4 NS Mother's Education, n (%)
High School or less 49 (29.0) 39 (22.3) NS College/vocational diploma 47 (27.8) 55 (31.4) Baccalaureate 46 (27.2) 46 (26.3) Post Baccalaureate 27 (16.0) 27 (20.0)
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Exposure to Own Mother’s Milk and Duration of Feeding
Intervention
Donor Milk (n=181)
Preterm Formula (n=182) P-value
Unpublished data to be presented
*Median (1st and 3rd quartiles)
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Mortality and Major Morbidities Donor Milk Preterm Formula P-value
(n=181 ) (n=182 )
Unpublished data to be presented
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Blinded NEC Evaluation
Team: neonatology and radiology Evaluation: clinical course, x-rays,
ultrasounds, surgical course, pathology Criteria: Stage 1: systemic and gastrointestinal symptoms with
non-specific x-ray changes Stage 2: systemic and gastrointestinal symptoms with
specific x-ray changes Stage 3: deterioration of vital signs/ septic shock +/-
pneumoperitoneum
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Weight-for-age Z-score: Study Day 1 to End of Feeding
Intervention
Unpublished data to be presented
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Length-for-age Z-score: Study Day 1 to End of Feeding
Intervention
Unpublished data to be presented
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Head Circumference-for-age Z-score: Study Day 1 to End of
Feeding Intervention
Unpublished data to be presented
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Cognitive, Language at Motor Development at 18-24 Months CA
Unpublished data to be presented
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Is There An Advantage of an Exclusive Human Milk Diet for NEC Prevention?
Infants fed mothers’ own milk randomized to:
1. HM100 2. HM40 3. BOV
*Sullivan et al Journal of Pediatrics 2010;156:562-7.
mother’s own milk +/- donor milk human milk based fortifier
mother’s own milk +/- preterm formula bovine milk based fortifier
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Is There An Advantage of an Exclusive Human Milk Diet for NEC Prevention?
*Sullivan et al Journal of Pediatrics 2010;156:562-7.
Unanswered question: Was it the donor milk or the human milk based fortifier that resulted in the significant reductions in NEC?
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OptiMoM Program
• Comparison of human milk-based and bovine milk-based fortification; (feeding tolerance, growth, GIT microbiome, gut inflammation)
• Long-term follow-up of DoMINO babies at Kindergarten; (neurodevelopment, neuroimaging, body composition, genotyping)
• Comparison of higher versus lower protein intake (5.0 vs 3.5 g/kg/d); (neurodevelopment, neuroimaging, growth, body composition, morbidity)
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Conclusions
• Cochrane Review: Use of donor milk compared to formula as a supplement is associated with a lower risk of NEC in VLBW infants but growth outcomes are inconsistent with optimal neurodevelopment.
• DoMINO Trial: To be presented
• Future directions: Research in this area is very thin. Work is required in optimizing mother’s own milk, donor milk and fortifiers.
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Current Recommendations for Human Donor Milk in Ontario, Canada
Eligibility: • <1500 g at birth • <32 weeks 6 days at birth • GI or cardiac surgery
Duration: • 4 weeks • Until 32 weeks and 6 days
http://www.milkbankontario.ca/