HUMAN MILK

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Human Milk in the NICU: The SPIN Program and
Human Milk Banking in Eastern Canada
Jae Kim MD PhD
UCSD Medical Center
Division of Neonatal-Perinatal Medicine
Division of Pediatric Gastroenterology, Hepatology and Nutrition
The Preterm Infant
Factors for Poor Milk Supply
• Maternal factors: stress, illness (hypertension), endocrine,
unable to access medical care (for mastitis, domperidone)
• Infant factors: illness, continuous feeds, specialty formula
• Physical barriers: geographical distance, cost of pump,
language barriers
• NICU factors: barriers between mom and baby, lack of
privacy to pump at bedside, multi-patient rooms
HMBANA (Human Milk Banking of North America)
Existing Milk Banks
Cities Served by Milk Banks
1.4 million ounces of milk annually
Adapted from http://hmbana.org/index/locations
Human Milk Processing
Images from Toronto SickKids Archives
Opens 2012
HUMAN MILK:
YOU CAN BANK ON IT!
A feasibility proposal for the creation of a
Human Milk Bank in Toronto to serve the
premature and surgical newborn population
The Ontario Human Milk Bank is committed to
ensuring that human donor breast milk is
safely collected, processed, and stored so that
it can be made available to all very low birth
weight preterm infants and surgical neonates
in eastern Ontario.
www.womenscollegehospital.ca
The Toronto Initiative
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Began with interdisciplinary team (Sunnybrook
Health Sciences Centre, SickKids Hospital,
Mount Sinai Hospital)
Regulatory approvals sought (Health Canada,
CFIA, Public Health)
Canadian Paediatric Society position statement
Funding obtained: Rogers Foundation and the Ontario
Ministry of Health and Long-term Care
Canadian Paediatric Society Statement
Reversed position of the CPS
Canadian Human Milk Banking
• Vancouver
• Calgary (opened 2012)
• Toronto (opening 2013)
•
•
•
•
Future
Edmonton
Regina
Montreal
CPS Human Milk Banking Statement
1. Pasteurized human donor milk is a recommended
alternative when mother’s own milk is not available
2. Should be prioritized to compromised preterm and
selected ill term newborns
3. Informed consent
4. Milk banking should be adopted as a cost effective
nutritional source for hospitalized neonates
5. There is a need for prospective studies to evaluate the
benefits of banked human milk
6. The CPS does not endorse the sharing of unprocessed
human milk
Criteria for Donor Milk Use
• Very low birth weight babies (<1500g)
• Gastrointestinal surgery in the newborn period
• Canadian (4 weeks of feeds and then transition to
alternate over 3 days)
• SPIN (up to 34 weeks adjusted age and then transition to
formula over 2 days)
WARNING: Formula milk may
cause NEC!
This is the way babies are supposed to be nourished
That is not going to work for this 600
gram baby!
But she really needs
her mother’s milk!
Vulnerabilities of the preterm infant
• Decreased immunoglobulin ✔
• Poor neurocognitive outcomes ✔
• Increased risk of NEC ✔
• Increased risk for infection ✔
• Increased intestinal permeability ✔
• Poor intestinal motility ✔
• Abnormal gut colonization ✔
• Delayed gastric emptying ✔
These are human milk benefits to the preterm infant
What are some of our challenges in
the NICU?
o
o
o
o
o
o
o
Infection
Necrotizing enterocolitis
Growth restriction
Feeding intolerance
Poor developmental
outcomes
Long hospital stay
Readmission
BABY FRIENDLY HOSPITAL INITIATIVE
 Started in 1991
 10 step plan for quality
improvement
 Multidisciplinary approach
 Education for parents
 Education of all staff
 Minimize formula company
exposure
 Evidenced based improvement
 Initial self assessment
 QI process
UCSD was home to origins of BFHI but
it took another 15 years to get
1990
Innocenti Declaration on
Breastfeeding Promotion
Pablo Picasso
SPIN PROGRAM
MISSION STATEMENT
“To create a Center of Excellence in neonatal
nutrition focused on the provision, analysis,
and research of human milk to improve
nutritional and long-term health outcomes of
premature babies”
PLANNING THE SPIN PROGRAM






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

Born Summer 2007
SPIN name adopted
Made timeline
Met frequently
Agreement on goals
Division of labor
Equipment needs
Neonatology support
Administrative support
 2 FTE: Lactation and Milk Tech
 Program roll-out March
2008
•
THE SPIN TEAM
Nutrition Director
• Lactation Director
• NICU F/U Neo
• NICU CNS
• Lactation
• OT
• NICU Dietician
• Research RN
• NICU Staff RN
SPIN Program
PINC
Outpatient
Clinic
NICU
Inpatient
SPIN
Program
Community
Outreach
Nutrition
Research
Team Building to Make More Milk
NUTRITION
LACTATION
IMPORTANT TO BRIDGE TWO DISCIPLINES
“Human Milk” vs “Breast Milk”
• Preterm infants start feeding by nasogastric or orogastric
tube
• Many preterm infants are just starting to breastfeed by the
time they are discharged
• Many preterm infants will only be fed human milk from a
bottle for their infancy
• Preterm infants require additional nutrient
supplementation for optimal growth at home; this often
requires pumping and mixing of milk
• Overall goal remains exclusive breastfeeding by 6 months
SPIN PROGRAM GOALS
1. Have a NICU nutrition/human milk policy
2. Educate all mother/baby staff in SPIN 10steps
3. Educate NICU families about optimal
premature infant nutrition
4. Prevent extra-uterine growth restriction
5. Standardize enteral feeding procedure
6. Aim for 100% human milk nutrition
7. Maximize mothers’ milk production
8. Optimize milk quality
9. Encourage skin-to-skin care and
breastfeeding
10.Plan a nutritional discharge from NICU
Benefits of Human Milk for the Very Low Birth
Weight Preterm Infant
 Less NEC
 Less infection
 Quicker attainment of
full feeds
 Shorter NICU stay
 Less hospital
readmission
 Higher IQ
Improving Milk Processing In NICU:
Milk Technician
 Milk technician position: dietary tech
 Collect morning milk order
 Use standard recipe to mix 24 hour
feedings
 Milk feeding put in syringes, or large
bottle once orally feeding
 Milk analysis will be incorporated into
practice to further improve optimal milk
product
 Benefits of milk tech:
 Ease RN workload
 Consistent preparation
 Minimize milk transfers
 Encourage use of fresh milk
Exclusive human milk reduces NEC and NEC
surgery
Sullivan et al (2010) J Pediatr. 2010;156:562-7
Human Milk Fortification
Bovine
HMF
Human
HMF
Human
Milk
Human
Milk
Standard
Exclusively Human
Results
HM
PF
p
Duration of TPN (d)
27
36
0.04
NEC
1
5
0.08
Surgical NEC
0
4
0.04
Cumulative morbidity
0.7 ± 0.5
1.2 ± 1.0
0.03
Length increment (cm/d)
0.12 ± 0.03
0.16 ± 0.04
0.006
This is the first randomized double-blind trial in infants of exclusive diets
of HM vs PF.
The significantly shorter duration of TPN and lower rate of surgical NEC
Cristafalo et al. H2MF group 2011, unpublished
MILK TRAFFIC
Mother
pumps
Milk in bottle
Milk in
storage
container
Milk in NICU
freezer
Milk in cooler
for transport
Milk in home
freezer
Milk thawed
Milk
measured
Milk fortified
Milk in baby
(finally!)
Milk in tubing
Milk drawn
into syringes
Routine Human Milk Analysis in the NICU
• Human milk is best, but:
– Varies in composition by
•
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•
mothers
time of day, week, month
timing of pumping
delivery system
– Current fortification methods are BLIND!
– Error margin at least 50%
Ideal Features of a Milk Analyzer
• Point-of-care
• Accurate
• Measures Protein, Fat,
and Carbohydrates
• Uses only a small
volume of milk
• Affordable
• Fast
• Small footprint
NIR Milk Analysis
• NIR analysis compared
to reference chemistry
• Excellent correlation
with protein, fat and
carbohydrates
Sauer et al 2010 J Perinatol.
Caloric variability of human milk
Results: nutrient content individual vs pooled
Calories vary by 29%
Oral Feeding Systems
Thawing milk
What method
Water bath
In fridge
Dry heater
What time period- 2436 hours after
thawing
How to keep it safe?
UCSD 2006 SELF ASSESSMENT
 Review current policies
and procedures
 Chart review of nutritional
measures for VLBW
 Literature review
 Search for best practices
 VON feeding data
SPIN Impact study baseline data
PRE-SPIN
(2006)
n
Gestational
Age, wks
Birth
Weight, g
Sepsis
NEC,%
SIP,%
IVH,%
ROP,%
SGA, n (%)
drop 1 zscore since
birth
drop 2 zscore since
birth
POST-SPIN
(2008+2009)
97
177
27.9
28.7
0.043
951.9
1032.8
0.028
55.2
5.8
9.5
19.6
21.6
21.60
42.8
2.2
6.3
21.5
22
27.70
0.037
NS
NS
NS
NS
NS
7.2
7.9
NS
40.2
38.4
NS
*
*
*
* p <0.05
Feeding Milestones
45
*
40
35
30
*
25
20
15
10
5
*
0
First Feeding First Fortification Max Calories
BW regained
Feeds stopped
Growth pre- and post SPIN
40
35
30
25
20
15
10
5
0
WT Birth
WT at DC
HC Birth
HC at DC
L Birth
L at DC
Z-scores pre- and post SPIN
0
-0.2
-0.4
-0.6
-0.8
-1
-1.2
-1.4
-1.6
-1.8
-2
WT Birth
WT at DC
HC Birth
HC at DC
L Birth
L at DC
SPIN PROGRAM AT UC SAN DIEGO MEDICAL
CENTER
spinprogram.ucsd.edu
QUESTIONS?
Human Milk Bank Processes:
UC San Diego, San Diego, CA
Jae H. Kim, Associate
Clinical Professor of
Pediatrics
[email protected]
619-543-3759
Background info
Brief description
How did your human milk bank (HMB)
began? When?
Toronto : 2013, Process began in 2005
Who provided initial funding? How are
ongoing operations funded? Integrated
into government services?
Toronto: Private donor for startup and construction, Provincial Ministry of Health for
some operating costs
Who regulates /oversees HMB in your
country/region (if any)?
Toronto: Health Canada has a role but does not have policy
How many HMBs are part of your system?
Where are they?
Canada: 2, Vancouver and Calgary
San Diego: The San Jose Mother’s Milk Bank services all of California
Is there a central HMB that processes milk
and distributes or many HMBs that
process milk and distribute? (Centralized
vs de-centralized)
San Diego: Centralized in San Jose
Canada: Toronto bank will be regional bank
How many NICU/Neonatal
wards/community homes does each bank
serve? Are they collocated?
San Diego: Numerous across California
Toronto: pending
How many babies does your
facility/system serve annually?
San Diego: 700 NICU admissions
How many liters/year does your
facility/system process annually?
San Diego: 200 L in use
How many donor mothers initiate donation
to your facility/system annually?
Toronto: pending
San Diego: a handful
Page 47
Process
Brief description of processes
Staffing
San Diego: See San Jose
Toronto: 1 FTE, 0.2 Director
Donor recruitment
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•
Toronto: pending
San Diego: See San Jose
Donor screening
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HMBANA guidelines
Recipient eligibility and
selection
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VLBW infants
Surgical infants
Physician request
Handling and storage of
donor milk (from
donation to feeding)
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Minus 20 freezer storage
Timeless Medical milk labeling and tracking
Process
Brief description of process
Transport of milk
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•
Toronto: pending
San Diego: See San Jose
Pasteurization
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•
Toronto: pending
San Diego: See San Jose
Tracking and record
keeping
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•
Toronto: pending
San Diego: See San Jose
Assessing milk quality
and safety (ie.
microbiology assays)
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•
Toronto: pending
San Diego: See San Jose
Quality assurance
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•
Toronto: pending
San Diego: See San Jose
Equipment/Location
Brief description of process
What is used/how many? • Pasteurizer
• Freezers (lockable?)
• Refrigerators
Additional HMB
equipment
requirements?
• Ex. lockable room
• Computers
• Other
Referral/feeder/depot
facilities?
• How many?
• Equipment requirements?
Neonatal ward
equipment
requirements?
• System for tracking usage?
• Freezer?
Other?
Organizational Successes
Brief description of top 3-5 successes
Policy
• Creation of a provincial / regional milk bank with Ministry support
• Creation of an interdisciplinary program centered on the
optimization of human milk nutrition for the preterm infant
(Supporting Premature Infant Nutrition program)
• Recognition nationally as Best Practice standard by JCAHO
• Early adoption by several NICU across the state and in America
Operational
• Use of human milk policies and donor HM associated with marked
reduction in necrotizing enterocolitis and sepsis in NICU
Technology
• Validated technology for human milk macronutrient analysis with
near infrared spectrophotometry
Page 51
Organizational Challenges
Brief description of top 3-5 challenges
Policy
• Lack of policy level support for standardizing human milk use in
the NICU.
Operational
• Identifying and retaining qualified staff for milk technician
Technology
• Concerns about the loss of nutrient and biologic value with
pasteurization
Page 52
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