SIROYS FM

A READY RECKONER
(Human Milk Fortifier)
1 gm per Sachet
To ensure long-term health and development of preterm infants, an early nutritional support is utmost
important. Breast milk is undoubtedly an ideal food for a preterm infant. However, the human milk fortifiers
protein, calcium, phosphorus, carbohydrate, vitamins and minerals. All infants with a birth weight below
1800g would benefit from the additional fortification of breast milk as per ESPGHAN recommendations
2009.The said fortification of breast milk aims to increase the optimum level of concentration of nutrients to
meet the requirements of all nutrients for preterm infants including those who are at the customary feeding
volumes. As no classification of infants who should receive fortified human milk (FHM) has been
recommended by any study in India and abroad, there is a general worldwide consensus amongst the
Neonatologists to prefer abovementioned recommendation of ESPGHAN 2009.
The results of a systematic review of ten randomized controlled trials1 generally support the use of HM
fortification as a common practice in neonatal intensive care units. Other trials2, 3 have not come out with any
significant differences.
Caution is also required as feeding these enriched diets may lead to disproportionate growth. Rapid catchup growth has been proposed as a potential contributor to a metabolic syndrome that results in long-term
adverse cardiovascular outcomes.

Composition of SIROYS FM 1gm (HMF) Sachet

Energy value
Protein
FAT
Carbohydrate
Calcium
Potassium
Phosphorus
Sodium
Vitamin C
Chloride
Magnesium
Iron
Nicotinamide
Pentothenic acide

3.5 Kcl
0.25 g
0.25 g
0.05 g
25 mg
1.95 mg
12.5 mg
4 mg
2.5 mg
2.2 mg
2 mg
0.36 mg
115 mcg
50 mcg

Zinc Sulphate
Folic Acide
ViaminB6
Copper Sulphate
Vitamin B2
Vitamin B2
Maganese
Vitamin K
Biotin
Vitamin B12
Vitamin A
Vitamin D3
Vitamin E

40 mcg
20 mcg
12.5mcg
12.5 mcg
10 mcg
6 mcg
0.85 mcg
0.55 mcg
0.25 mcg
0.025 mcg
155 IU
100 IU
0.62 IU

Brief Analysis of Contents

Protein: The most common approach is multi-nutrient packaged powdered fortifiers. Protein replacement in
VLBW poses the most difficult challenge. Preterm infants accrete protein at a higher rate than term infants
and, therefore, the protein requirements of preterm infants are higher. ESPGHAN Committee on Nutrition
recommends aiming at 4.0 to 4.5 g kg/day protein intake for infants up to 1000 g, and 3.5 to 4.0 g for
infants from 1000 to 1800 g that will meet the needs of most preterm infants. However, human milk alone
provides inadequate amounts of protein, energy and minerals to meet the high needs for preterm infant
growth. It has been shown that adequate protein intake has impact not only on short term growth but also
on long term neurological outcome. A Cochrane analysis showed that protein supplementation of human
milk in preterm infants lead to increase in short term weight gain (WMD 3.6 g/kg/day, 95% CI 2.4 to 4.8
g/kg/day), linear growth (WMD0.28cm/week, 95% CI 0.18 to 0.35 cm/week) and head growth (WMD 0.15
cm/week,95% CI 0.06 to 0.23 cm/week).
As HM shows variability in protein content, it often results in an unpredictable nutrient intake. Actual intakes
of protein by preterm infants fed fortified human milk are substantially lower than assumed intakes. The
discrepancy may in part explain why preterm infants who are fed fortified HM also frequently show postnatal
growth failure.
Individualized fortification is now emerging as the best solution to the problem of protein under nutrition
with standard fortification of HM. Given the large variability in nutrient composition of breast milk it is
difficult to know how much fortifier to provide. Some have proposed analyzing individual aliquots of breast
milk it is difficult to know how much fortifier to provide. Some have proposed analyzing individual aliquots of
breast milk but this technique is not routinely available. Adjusting fortification uses periodic determinations
of serum urea as a guide to protein intake, and adjusting the intake of fortifier and supplemental protein
accordingly. This technique resulted in better weight gain and head growth compared to a control group
receiving standard fortification.
Also, protein and energy needs should be considered concurrently. Protein to energy ratio (P: E ratio) should
be in the optimal range. It has been recommended that 2.8g/100 kcal to 3.4 g/100 kcal should be the
minimum and maximum and maximum P: E ratio. The energy content of HMF could influence the gastric
emptying, with implications for the management of premature infants at greater risk of feed intolerance.

Carbohydrate: The expert panel for LSRO has based its carbohydrate intake recommendations in relation
to the needs of other macronutrients and has recommended a minimum of 9.6 g/100 kcal and a maximum of
12.5g/100 kcal. So the fortifier should aim to provide this amount of carbohydrate.

Iron: The quantity of iron in human milk fortifiers differs and directly affects the activity of lactoferrin.
Lactoferrin is a glycoprotein that binds iron so bacteria cannot use it for metabolism. If lactoferrin binds iron,
it is rendered inactive; thus, lactoferrin needs to be in a state that is not found to be active. A few studies
have shown that addition of iron decreases the antimicrobial property of the human milk and therefore, iron
supplementation should be given separate from HM feedings.

However, it has also been demonstrated that using the iron-fortified product may reduce the need for
blood transfusions in VLBW infants. This study also demonstrated low rates of suspected and confirmed
NEC and sepsis and refuted the premise that the inclusion of iron in fortifiers will increase the incidence of
sepsis and NEC. So further research is needed regarding the optimum content of iron in HMF.

Mineral: Human Milk fortifiers contain different quantity and quality of minerals and their effect on bone
mineral content is still unclear. Calcium absorption is dependent on the quantity and the source of calcium
salt and quality and quantity of fat content of the diet. In using human milk fortifiers, it has been suggested
that soluble calcium salts bind the fatty acids in the fortified human milk, thus impairing fat absorption,
lowering energy intake, and decreasing the rate of growth. Schanler and Abrams reported that preterm
infants receiving that powdered HMF containing highly soluble calcium and phosphorus demonstrated poorer
at absorption, compared with similar infants fed powdered HMF containing insoluble calcium and
phosphorus. So insoluble calcium salts like calcium phosphate tribasic and calcium carbonate should be used
to optimize fat absorption. As per W H O guidelines there is low quality evidence that routine calcium and
phosphate supplementation reduces the risk of metabolic bone disease in preterm VLBW infants. Also there
is no evidence of reduction in the risk of rickets of prematurity. So, fortification with minerals, trace mineral
and vitamins presents few problems. Although the exact requirement for many of these nutrients is
unknown, aiming at meeting or, more often, exceeding the presumed requirements has proved successful.
This is so because neither modest degree of shortfalls nor of excesses of these nutrients appears to pose any
problems. None of these nutrients are limiting growth.

Osmolality: Osmolality is a critical determinant of feed tolerance. Cochrane meta-analysis has shown an
increased tendency for feed intolerance with fortified milk. Various studies have demonstrated that
Osmolality of breast milk increases significantly on fortification with HMF and LBW formula. The rise of
Osmolality observed in human milk supplemented with HMF can be explained by the fact that
polysaccharides, present in the HMF, are broken down into their constituent mono and oligosaccharides and
the difference observed between the various HMF could be related to the different carbohydrate content
and the use of dextrin of different origin and equivalent glucose content. So we expect an ideal fortifier to
alter the Osmolality of human milk to minimum. The lower Osmolality may improve the feeding tolerance,
thereby providing indirect benefits to growth. Some fat may be used in place of carbohydrate to reduce the
Osmolality of the fortifier.
The commonly used fortifiers are powdered products that are different from liquid fortifiers in that they do
not further dilute maternal milk when added. Recently liquid ultra-concentrated fortifier has been used. This
new LHMF with higher protein has been shown to enhance both lengths as well as weight growth in preterm
infants with birth weight less than 1250 g, with minimal metabolic and host defense impact compared with
currently available powdered fortifier.

Comparison of content with other Brands.

Nutrient
Energy, Cal
Protein, g
Fat, g
Linoleic Acid, mg
Carbohydrate, g
Vitamin A, IU
Vitamin D, IU/day
Vitamin E, IU
Vitamin K, mcg
Vitamin C, mg
Calcium, mg (mEq)
Phosphorus mg (mEq)
Iron, mg
Sodium, mg (mEq)
Potassium, mg (mEq)
PRSL, mOsm
Osmolality (mosm/kg water)

ESPGHAN
(/kg/ day)
110-135
3.5-4.5
4.8-6.6
385-1540
11.6-13.2
1320-3300
800-1000
2.2-11
4.4-28
11-46
120-140
60-90
2-3
69-115
66-132

Human milk
(100 ml)
67
1.1
3.5
7.0
48
8

25.3
14.5

Similac
(4 Pkts)
14
1
0.36
1.80
620
120
3.2
8.3
25
117(5.48)
67(2.16)
0.35
15(0.65)
63(1.61)
11.2
+95

Enfamil
(4 Pkts)
14
1.1
1
140
0.2
950
150
4.6
4.4
12
90
50
1.44
16
29
9.7
+ 35

Lactodex
(2 Pkts)
15
0.4
0.2
3
240
76
2.5
2.2
10
100
50
3.5
7.8

Siroys FM
(4 Pkts)
14
1
1

xxx

+25

0.2
620
400
2.48
2.2
10
100
50
1.44
16
7.8

Cost: In a developing country like ours, the cost factor is also of utmost concern. Therefore, wastage due to
contamination while storing unused portion of existing HMF 2g sachet is totally avoided to achieve economy
in cost, besides providing an ideal formulation as stated above.
SIROYS FM is an ideal HMF and most advanced formulation which meets the urgent nutrients requirement of
Preterm, LBW and ELBW infants.
SIROYS FM 1gm per Sachet is the most Pioneers in India.
Dosage: One SIROYS FM 1gm sachet well mixed with breast milk 25ml for single feed to infants. The same
method may be repeated for each next feed in a day at required intervals as directed by
Neonatologists/Health Expert. Optimum frequency of feed within 24 hours 4 to 8 times or more as advised by
neonatologist.

Direction for use

(1) Mix well the entire contents of one sachet with 25ml of mothers milk.
(2) Now SIROYS FM is ready for feed.
(3) Repeated for each next feed in a day at required intervals as directed by Neonatologists/ Health Expert.

Frequently Asked Questions (FAQs)

1. What is the optimum condition requiring HMF to an infant? Are there any national and

international guidelines on the use of (HMF)?

The preterm infants <32 weeks gestation or <1500g birth weight, who fail to gain weight despite full
volumes of breast milk feeding, are the best suited for use of additional fortification of breast milk.
However, in absence of sufficient data to categories a particular infant who should receive fortifier human
milk, there is a general consensus that all infants with birth weight below 1800g would benefit from
additional fortification as per ESPGHAN 2009. The existing WHO and NNF guidelines somehow also
support the abovementioned condition for use of additional multi component fortification of breast milk.

2. What are the short and long term benefits of HMF?

A systematic review of ten randomized controlled trials (more than 600 infants with birth weight less than
1850 g multi-component fortification of HM compared with the feeding of unfortified HM was associated
with small but statistically significant short-term improvements in weight gain (+2.33 g/kg/d; 95%CI 1.73,
2.93), linear growth (+0.12 cm/week ; 95%CI 0.07, 0.18), and head growth (+0.12 cm/week; 95%CI 0.07,
0.16)(1) . Only two trials have evaluated long-term growth effects of HM fortification and did not
demonstrate any difference in weight, length or head circumference at 12 and 18 months of corrected
age(2, 3). Only one trial looked at developmental performance at 18 months: at this age test scores were
higher in the fortifier in the fortified group by 2.2 points for the Bailey Mental Development Index, by 2.4
points for the Psychomotor Development Index, and by 3.1 points for social maturity, but these
differences were not significant.
3. What are the pros and cons of adding Iron to HMF?
In Indian context with high prevalence of Iron deficiency in Indian mothers and more SAG status in
preterm and LBW neonates, addition of 1mg Iron/100ml of human milk would meet up with ESPGHAN
guidelines and would go a long way in reducing Iron deficiency anaemea in Indian infants.
4. Discuss importance of protein content of HMF?
Adequate protein intake has impact not only on short term growth but also on long term neurological
outcome. Cochrane analysis showed that protein supplementation of human milk in preterm infants leads
to increase in short term weight gain (WMd 3.6g/kg/day, 95CI 2.4 to 4.8g/kg/day), linear growth (WMD
0.28cm/week, 95% CI 0.38cm/week) and head growth (WMD 0.15 cm/week, 95% CI 0.06 to 0.23cm/week)
5. What are the various types of fortification used?
The three different forms of fortification are standard, tailored and adjustable. {4,5}

(1) Standardized:- Adding a constant amount of fortifier without taking into account the initial milk
composition from each individual mother.
(2) Tailored (a Ia carte ):- Based on milk analysis. The amount of fortifier is adjusted according to weekly
determinations of milk protein content to achieve target protein intakes at all times.
(3) Adjustable :- Based on the metabolic response of the infant. The amount of fortifier is adjusted after
determining blood urea nitrogen as an index for adequacy of protein intake.
6. Which Calcium salts should be used as HMF constituent and why?
Insoluble calcium salts such as calcium phosphate tribasic and calcium carbonate should be used as these
optimize fat absorption. Whereas, calcium salts bind fatty acids in milk, thus impairing fat absorption.
7. What are adverse effects of HMF feared of?
Osmolality is a critical determinant of feed tolerance. Rise of Osmolality observed can be explained by the
fact that polysaccharides present in HMF, are broken into constituent mono and oligosaccharides. So we
expect an ideal fortifier to alter Osmolality to minimum. The Cochrane review, on the basis of the small
number of infants for whom this outcome was reported, showed a non-significant trend toward an
increased risk of feed intolerance in treated infants (RR2.85, 95% CI 0.62 to 13.1)(1). Among the reasons
used to advocate HM feeding for VLBW infants is the belief that it is advantageous in reducing infections
when compared to preterm formula. HM is a highly complex secretion with live cells and a wide variety of
biologically active factors; it has anti-infective properties due to the high content of lgA, lysozyme,
lactoferrin, and interleukins. A possible concern with HMF is that the added nutrients may affect these
unique qualities. Adding HMF was reported to be associated with some lysozyme and lgA reduction but
this observation was not replicated in later studies. Total bacterial colony counts in milk stored at
refrigerator temperature are significantly greater in fortified than in unfortified milk; however, the
magnitude of this difference may not e of biological importance. From a clinical point of view, a systematic
review comparing infants fed unfortified and fortified HM did not show any significantly increased risk of
NEC in infants receiving FHM (RR 1.33, 95%CI 0.7 to 2.5)
8. When Should HMF be stopped?
There are no standard evidence based guidelines for the same. If the baby is on direct breast feeds at the
time of discharge, HMF fortification is usually discontinued as it interferes with direct breast feeds. If baby
is on expressed breast milk, then HMF should be continued till baby achieves its birth percentile on
growth charts. Conventionally in such cases HMF is continued till 40 weeks.
9. Energy Value
Human milk has an average of 67 Cal /100ml and addition of SIROYS FM/100ml human milk provides
additional 14 calories, thus, making it a total of 81 Cals/100ml. the Calories in SIROYS FM come from FAT
and PROTIEN and not from carbohydrates. It adds value to the product and at the same cuts down the
Osmolar Load.

Bibliography
1. Kuschel CA, Harding JE. Multicomponent fortified human milk for promoting growth in preterm
infants (Cochrane Review). Cochrane Library 2004;3
2. Lucas A, Fewtrell MS, Morley R, al. Randomized outcome trial of human milk fortification and
development outcome in preterm infants. Am J clin Nutr 1996;64:142-51.[40]
3. Wauben IPM, Atkinson SA, Shah JK, et al. Growth and body composition of preterm infants: influence
of nutrient fortification of mothers milk in hospital and breastfeeding post-hospital discharge. Acta
Paediatr 1998; 87:780-5.
4. More GE, Minoli I, Ostrom M, Jacobs JR, Picone TA, Raiha NC, et al. Fortification of human milk:
evaluation of a novel fortification scheme and of a new fortifier. J Pediatr Gastroenterol Nutr
1999;20:162-72.
5. Arslanoglu S, Moro GE, Ziegler EE. Adjustable fortification of human milk fed to preterm infants: does
it make a difference? I Perinatol 2006;26:614-21.

www.siroylifesciences.com