Practical Application of Osmometry for the Evaluation of Human Milk

SCIENTIFIC
WHITEPAPER
Practical Application of Osmometry
for the Evaluation of Human Milk
and Infant Nutritional Products in
the Neonatal Intensive Care Setting
Andrea Curria, Kelly Peterson.
Advanced Instruments, Inc., Norwood, MA
Page 1
“
The American Academy of Pediatrics (AAP)
recommends that the
osmolality of formulas
for ‘normal’ infants
should not exceed
450 mOsm/kg H20.”
“
It has been well
documented that
hyperosmolar substances
have been associated with
a wide variety of gastrointestinal illnesses in neonatal populations including
necrotizing enterocolitis
(NEC).”
Page 3
Materials
Type
Description:
Serial or Lot
Number:
Osmometer
Advanced Model 3220 Micro-Osmometer
SN 04121118A
Osmometer Supplies
50 mOsm/kg Calibration Standard (3MA005)
Lot # 0309190
850 mOsm/kg Calibration Standard (00A085)
Lot # 0409080
290 mOsm/kg Reference Standard (3MA029)
Lot # 0402010
Imfant Nutritional
Enfamil EnfaCare Lipil Powder (Cow’s Milk Based)
Lot # QL545
Products
Enfamil ProSobee Lipil Powder (Soy Based)
Lot # BD562
Enfamil Lipil Nutramigen Powder (Protein Hydrolysate)
Lot # MFS22
Enfamil Premium Lipil 20 Powder (Cow’s Milk Based)
Lot # ENFG05
Enfamil ProSobee Lipil Ready to Use (Soy Based)
Lot # MLS18
Enfamil Lipil Nutramigen Concentrated (Protein Hydrolysate)
Lot # MHS10
Enfamil Lipil 20 Concentrated (Cow’s Milk Based)
Lot # MKS07
Similac Alimentum Ready to Use (Protein Hydrolysate)
Lot #82542RH
Similac Sensitive for Spit Up Ready to Use (Cow’s Milk Based)
Lot # ISADPWO
Similac Advance Ready to Use (Cow’s Milk Based)
Lot # SIMESPW
Similac Sensitive for Spit Up Powder (Cow’s Milk Based)
Lot# SSRSPWD
Similac Sensitive Powder (Cow’s Milk Based)
Lot# SSENFWC
Similac Alimentum Powder (Protein Hydrolysate)
Lot # 82927RAD
Good Start Soy Plus Concentrate (Soy Based)
Lot # HPC3013
Good Start Gentle Plus Concentrate (Cow’s Milk Based)
Lot# GGC3050
Good Start Gentle Plus Ready to Use (Cow’s Milk Based)
Lot# GGR3043
Good Start Gentle Plus Powder (Soy Based)
Lot# GGR3043
Human Milk MMB of Iowa Pooled #1
Lot # P463-4
Human Milk MMB of Iowa Pooled #2
Lot # P496-4
Human Milk MMB of Iowa Pooled #3
Lot # P474-1
Human Milk Samples
Human Milk MMB of Iowa Single Donor #1
Human Milk MMB of Iowa Single Donor #2
Human Milk MMB of Iowa Single Donor #3
Human Milk Indiana MMB Pooled #1
Human Milk Indiana MMB Pooled #2
Human Milk Indiana MMB Pooled #3
Human Milk Indiana MMB Single #1
Human Milk Indiana MMB Single #2
Human Milk Indiana MMB Single #3
Page 5
MATERIALS AND METHODS (cont.)
Table 1. Powdered Infant Formulas
Average
Brand Name
Osmolality (mOsm/Kg)
Manufacturer’s Label
% Difference
S.D.
CV
Claim(20,21,22)
Label Claim and Calculated
(n=20)
Enfamil EnfaCare Lipil
333.0
2.8
0.8
300
10.4
Enfamil Prosobee Lipil
187.3
2.1
1.1
170
9.7
Enfamil Nutramigen Lipil
299.7
1.6
0.5
300
0.1
Enfamil Lipil 20
304.8
1.9
0.6
300
1.6
Good Start Gentle plus
226.3
1.5
0.6
250
10.0
Similac Sensitive for Spit-Up
175.7
3.3
1.9
180
2.4
Similac Sensitive
229.4
1.7
0.7
200
13.7
Similac Alimentum
326.0
2.5
0.8
320
1.9
Table 1. Results for the eight (8) powdered infant formulas tested. The osmolality ranged from 175.7 up to 333.0 mOsm/kg, which showed good correlation (0.1%
to 13.7% difference) with manufacturer’s label claims that ranged from 170 up to 320 mOsm/kg. Coefficient of variation (CV) for all samples tested were very good
and were between 0.5 up to 1.9.
Table 2. Infant Formula From Liquid Concentrate
Average
Brand Name
Osmolality (mOsm/Kg)
Manufacturer’s Label
% Difference
S.D.
CV
Claim(20,21,22)
Label Claim and Calculated
(n=20)
Enfamil Nutramigen Lipil
296.4
1.7
0.6
300
1.2
Enfamil Lipil 20
308.3
2.1
0.7
300
2.7
Good Start Gentle plus
260.1
1.8
0.7
250
3.9
Good Start Gentle Soy plus
178.1
1.5
0.8
180
1.1
Table 2. Results for four (4) liquid concentrate infant formulas tested. The osmolality ranged from 178.1 up to 308.3 mOsm/kg, which showed very good correlation
(1.1% to 3.9% difference) with manufacturer’s label claims that ranged from 180 up to 300 mOsm/kg. Coefficients of variation (CV) for all samples tested were
very good and were between 0.6 up to 0.8.
Table 3. Ready-to-use Liquid Infant Formula
Average
Brand Name
Osmolality (mOsm/Kg)
Manufacturer’s Label
% Difference
S.D.
CV
Claim(20,21,22)
Label Claim and Calculated
(n=20)
Enfamil Prosobee Lipil
170.3
1.7
1.0
170
0.2
Good Start Gentle plus
268.6
1.7
0.6
250
7.2
Similac Alimentum
385.1
2.3
0.6
370
4.0
Similac Sensitive for Spit Up
172.9
1.5
0.9
180
4.0
Similac Advance
304.8
1.8
0.6
310
1.7
Table 3. Results for five (5) liquid infant formulas tested. The osmolality ranged from 170.3 up to 385.1 mOsm/kg, which showed very good correlation (0.2% to
7.2% difference) with manufacturer’s label claims that ranged from 170 up to 370 mOsm/kg. Coefficients of variation (CV) for all samples tested were very good
and were between 0.6 up to 1.0.
Page 7
Table 4. Pooled Donor Human Milk
Average
Brand Name
Osmolality (mOsm/Kg)
S.D.
CV
(n=20)
Indiana MMB Pooled #1
279.7
1.8
0.6
Indiana MMB Pooled #2
291.5
1.4
0.5
Indiana MMB Pooled #3
261.0
1.3
0.5
Iowa MMB Pooled #1
307.5
3.7
1.2
Iowa MMB Pooled #2
304.5
2.3
0.8
Iowa MMB Pooled #3
271.7
2.0
0.8
S.D.
CV
Table 5. Single Donor Human Milk
Average
Brand Name
Osmolality (mOsm/Kg)
(n=20)
Indiana MMB Single #1
312.8
1.7
0.5
Indiana MMB Single #2
310.4
1.4
0.5
Indiana MMB Single #3
283.6
2.0
0.7
Iowa MMB Single Donor #1
316.1
3.1
1.0
Iowa MMB Single Donor #2
296.2
2.7
0.9
Iowa MMB Single Donor #3
313.7
3.6
1.1
Page 9
REFERENCES (cont.)
ACKNOWLEDGMENTS
Advanced Instruments would like to give special thanks to Indiana Mothers Milk Bank and the Mothers
Milk Bank of Iowa for providing the human milk samples used in this study.
Page 11
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MKT SP 0007 04/26/11