Given the significant health benefits to both infant and mother, health workers have a responsibility to promote breastfeeding first but, if infant formula is needed, to educate and support parents about formula feeding.

The aim is to ensure the safe preparation, storage, handling and administration of infant formula in both the hospital and home settings based on current evidence based research.

FAO -Food and Agriculture Organization

WHO - World Health Organisation

US CDC - United States Centre for Disease Control

INC - Infant Nutrition Council (INC)

When infants are not breastfed, infant formula is the only suitable and safe alternative to meeting their primary nutritional needs

If supplementary feeding is needed in hospital, it should only be given for specific medical indications and with the mother's consent.

This guideline is for the healthy term newborn in the postnatal ward only. Infants admitted to the Special Care Nursery or who require medically indicated supplementary feeds should be managed according to the appropriate guidelines.

A baby who is not receiving breast milk should be fed infant formula as cows milk is not suitable for children less than 12 months of age.

Choice of formula
In Australia, a range of cow's milk and goat's milk formulas that meet the Australia New Zealand Food standards code for infant formula are available. There is little evidence that, if breastfeeding is discontinued for any reason, one formula is better than another for healthy full-term infants:

• use of a particular formula by a hospital does not mean that formula is the 'best' one

• interchange between formulas within the same generic group is optional, however frequent changes may generate confusion and increases the risk of inaccurate preparation/dosing

• the use of 'follow-on formula' for infants aged 6-12 months is not considered necessary and no studies have shown advantages over using 'infant formula'

• it is preferable to use a formula with a lower protein level.

If an infant has a diagnosed cows milk protein allergy, a specialty formula may be used under the guidance of a medical professional or healthcare worker.

Bottles and equipment

• In the hospital setting all equipment is provided for preparation, storage and administration of formula. All equipment including bottles, storage containers and teats are single use and disposable. In the postnatal ward mothers must supply their own infant formula. Please note that hospital supplied formula is for special care nursery use only.

• In the home setting mothers/caregivers are encouraged to have at least 2-3 large plastic bottles with measurement guides, leak proof caps, discs and teats. The equipment should be easy to clean and the mother is given information on how to clean and sterilise the equipment.

• Teats are selected according to flow rate and shape.  The flow rate is according to the infants age and teat shape is according to the mothers/caregivers personal preference and what works best for each baby.

Preparing infant formula

Safe bottle-feeding depends on a safe water supply, sufficient family income to meet the costs of continued purchase of adequate amounts of formula, effective refrigeration, clean surroundings and satisfactory arrangements for sterilising and storing equipment. Tap water is preferred for preparing infant formula rather than using bottled water (consistent with the Australian Dietary Guidelines). All tap water used to prepare infant formulas should be boiled and cooled to lukewarm according to the instructions on the formula package label.

As health workers are the only group authorised to demonstrate infant formula feeding, it is essential that they show the correct methods and monitor methods regularly.

Risks associated with incorrect preparation of infant formula

Powdered infant formula is not a sterile product and there are occasional infections of infants with Cronobacter sakazakii (also known as 'Enterobacter sakazakii'), with higher risk in low birth weight infants. C. sakazakii is invasive and has a high mortality rate. A Food and Agriculture Organization/ World Health Organisation (FAO/WHO) review of C. sakazakii infections worldwide identified around 120 documented cases among infants and young children up to 3 years of age. However globally, there appear to be very few surveillance data for C. sakazakii-related illnesses. In developed countries, the risk is relatively low and the United States Centre for Disease Control reported only 46 cases over a 40-year period. There have been no reported cases in Australia.

The FAO/WHO have developed a risk-assessment model and advice on the control of contamination in powdered infant formulas. Since these measures have been introduced the levels of contamination have reduced. A testing program undertaken in New South Wales did not find any cases of contamination in the samples of infant formula tested.

The WHO advocates the use of water at 70c for preparing formula as this temperature will destroy bacteria. However, vitamins and nutrients will also be destroyed and use of water at this temperature brings the risk of serious burns. Infants are not at risk from C. sakazakii when formula is prepared with lukewarm (body temperature), previously boiled water and fed within 1 hour. As the risk of infection from C. sakazakii is negligible in Australia if correct preparation techniques are followed, the Infant Nutrition Council (INC) advocates the use of water at body temperature (i.e. not hotter than 37 degrees celsius), which poses no risk of nutrient deficiency or scalding.

Preparation of infant formula

All parents/caregivers who are using infant formula are given one to one supervised instruction regarding safe preparation, storage, handling and administration of infant formula. This instruction should ideally involve other family members who may be preparing formula at home e.g. partner, grandparent.

All parents/caregivers are given the Grampians Health consumer information "Infant formula information for parents" which includes the Raising Children's Infant Formula Preparation handout.

Parents with low literacy skills or from a non-English speaking background may need extra help and supervision to ensure that formula preparation and bottle feeding is done safely.

1. Always wash hands before preparing formula and ensure that formula is prepared in a clean area

2. Wash bottles, teats, caps and knives - careful attention to washing is essential - and sterilise by boiling for 5 minutes or using an approved sterilising agent.

3. Boil fresh water and allow it to cool until lukewarm - to cool to a safe temperature, allow the water to sit for at least 30 minutes (in places with clean water supply which meets Australian standards, hot water urns such as hydroboils are safe to use for formula reconstitution, provided the supply of very hot water has not been depleted).

4. Ideally prepare only one bottle of formula at a time, just before feeding

5. Always read the instructions to check the correct amount of water and powder as shown on the feeding table on the back of the
   pack - this may vary between different formulas.

6. Add water to the bottle first, then powder

7. Pour the correct amount of previously boiled (now cooled) water into a sterilised bottle

8. Always measure the amount of powder using the scoop provided in the can, as scoop sizes vary between different formulas

9. Fill the measuring scoop with formula powder and level off using the levelling device provided or the back of a sterilised knife -
   the scoop should be lightly tapped to remove any air bubbles

10. Take care to add the correct number of scoops to the water in the bottle - do not add half scoops or more scoops than stated in
    the instructions

11. Keep the scoop in the can when not in use - do not wash the scoop as this can introduce moisture into the tin if not dried adequately

12. Place the teat and cap on the bottle and shake it until the powder dissolves

13. Test the temperature of the milk with a few drops on the inside of your wrist - it should feel just warm, but cool is better than too hot

14. Feed infant - any formula left at the end of the feed must be discarded

15. A feed should take no longer than 1 hour - any formula that has been at room temperature for longer than 1 hour should be discarded

16. Formula that has been at room temperature for less than 1 hour may be stored in a refrigerator for up to 24 hours (in a sterile
    container) - discard any refrigerated feed that has not been used within 24 hours

17. When a container of formula is finished, throw away the scoop with the container, to ensure that the correct scoop is used next time.

Sterilisation methods

1. Ensure a clean dedicated area for preparation and storage of infant formula.
2. Always wash and dry hands before preparing formula and handling equipment.
3. Wash bottles and teats thoroughly in warm soapy water and rinse.
4. Sterilize equipment using the one of the following methods;

• Boiling - Place utensils, including bottles, teats and caps into a large saucepan and cover with water, making sure to eliminate all air bubbles from the bottle. Bring to boil and boil for 5 minutes. When cool enough to handle lift out of water, screw on the caps and store them in the refrigerator. Boil all equipment within 24 hours of use.

• Chemical Sterilization (liquid/tablet form) - Follow the manufacturers instructions when making up the solution. Use a container that holds enough solution to cover all the equipment. The equipment can stay in the solution until needed. Keep away from direct sunlight and change the solution daily. Chemical sterilisation is not as effective as boiling unless bottles and other utensils are meticulously cleaned.

• Steam sterilization - There are small electric units available from the chemist and microwave sterilizing units also available. The user should follow the manufacturer's instructions.

'Ready to drink' formulas
'Ready to drink' infant formula products are available in aseptically packed plastic bottles for hospital use only or in aseptically packed tetra packs for domestic use. The liquid formula needs to be poured into a sterilised bottle and can be warmed in the bottle if desired, just before feeding. However once opened, 'Ready to drink' formats (plastic bottle or tetra pack) may be poured into numerous sterilised bottles provided that these bottles are refrigerated below 5c continuously and used within 24 hours. Any unfinished formula left in the bottle after a feed must be discarded and not kept for use in a later feed.

Preparing feeds in advance
Ideally only one bottle of formula should be prepared at a time. If formula needs to be prepared in advance (e.g. for a babysitter or to take to a child care centre) it must be refrigerated (at 5c or below) and used within 24 hours. Alternatively, prepared sterilised bottles of boiled water may be refrigerated and used as required, first warming by standing bottle in a container of warm water and then adding formula.

In the hospital setting

It is best to make infant formula fresh for each feed and to consume immediately, as reconstituted formula provides ideal conditions for the growth of harmful bacteria.
In care or hospital settings, for practical reasons, feeds may need to be prepared in advance and stored until required. The following points outline the safest practice for preparing feeds in advance and storing for later use.

• A batch of formula should be prepared in a clean, sterilized container that is no larger than 1 litre and has a lid.

• Formula should be labelled with appropriate information, such as type of formula, infant's name or ID, time and date prepared.

• The prepared formula can be refrigerated in the lidded container and dispensed into bottles as needed.

• Place cooled formula in a dedicated refrigerator. The temperature of the refrigerator should be no higher than 5 degrees celsius and should be monitored daily.

• Feeds can be stored in the refrigerator for up to 24 hours

It is not recommended that batches of formula are cooled and stored in large volumes as large volumes can promote inadequate cooling and hence lead to the growth of harmful bacteria.

Re-warming stored feeds

1. Remove feeds from the refrigerator just before they are needed.
2. Re-warm for no more than 15 minutes.
3. To ensure that the feed heats evenly, periodically shake or swirl the feed in its covered container.
4. Check feeding temperature in order to avoid scalding the infant's mouth.
5. Discard any re-warmed feed that has not been consumed within two hours.

Note: microwave ovens should never be used for re-warming feeds as uneven heating may result in 'hot spots' that may scald the infant's mouth.

Transporting feeds
It is much safer to prepare bottles of infant formula at the destination, rather than transporting bottles of prepared formula. Harmful bacteria thrive in warm, moist conditions. Ready-made bottles of prepared formula can be a breeding ground for bacteria if the bottles have been sitting in a car or baby bag for several hours, especially on a warm day. Because of the potential for growth of harmful bacteria during transport, feeds should first be cooled to no more than 5 degrees celsius in a refrigerator and then transported.

Instructions for parents/caregivers

1. Prepare the feed and put in the refrigerator

2. Ensure feed is cold before transporting

3. Do not remove feed from the refrigerator until immediately before transporting

4. Transport feed in a cool bag with ice packs

5. Use feeds transported in a cool bag within 2 hours, as cool bags do not always keep foods adequately chilled

6. Re-warm at the destination (for no more than 15 minutes)

7. If the destination is reached within 2 hours, feeds transported in a cool bag can be placed in a refrigerator and held for up to 24 hours from the time of preparation

There are a number of special containers available designed to carry single serves of infant formula. It is also recommended to take one or more separate sterilised bottles of cooled boiled water at the correct volume, so the formula can be prepared at the destination. Alternatively, single-serve sachets of infant formula powder are available. Manufacturer's instructions should always be checked before use.

Storage and handling of infant formula

In the hospital setting;

1. In the postnatal ward, infant formula for a non-breastfed baby is supplied by the infant's mother and the tin is stored at her bedside.
2. Once prepared, formula is stored in a dedicated fridge in the 'milk room' in the postnatal ward. It must be stored in the main part of the fridge NOT in the door. The temperature of the refrigerator should be no higher than 5 degrees celsius and should be monitored daily.
3. All equipment used for the preparation of infant formula is single use and disposable.
4. All infant formula is labelled with the mother's name, date and time of preparation and discarded after 24 hours.
5. All staff and parents are expected to wash their hands prior to any infant formula preparation.

In the home setting (included in discharge education for mothers/caregivers);

1. Always have a clean dedicated area for infant formula preparations.
2. Always wash hands prior to contact with infant feeds/equipment.
3. Store all prepared formula in the main section in the centre of the fridge.
4. Discard the contents of a partially used feed after 1 hour and do not reuse feed.
5. Check the expiry date on all tins of formula and discard if out of date and opened tins are discarded after 1 month.
6 .Bottled water may be used in an emergency however is not recommended for general use as it is the boiling process which kills the bacteria in the milk.
8. The bottle should be warmed for no longer than 15 minutes as bacteria multiply rapidly in warm formula if warming is extended.
9. Infant formula should not be over heated and should not be warmed in a microwave as due to inconsistent heat distribution there is a risk of scolding the infant's mouth.

Feeding infant formula

Fluid requirements

• The volume of fluid required per feed in a 24-hour period is based on the infant's weight and age.

• All feed volumes should be introduced gradually and in the first few days of life small volumes should be gradually increased as the infants stomach needs to gently adapt to the amount.

Mothers/care-giver's should be encouraged to demand feed and be aware of the signs that the infant is being fed enough and is well hydrated. Advice should include;

• The infant should be fed as much as he/she wants as often as demanding. If the infant is regurgitating or vomiting after a feed suggest offering a smaller amount the next feed.

• Newborn babies take small volumes to start with and by the end of the first week will be having around 150-200 mls per kg per day.

• Giving lots of milk in one feed will not necessarily enable the infant to go longer between feeds. It is just as likely to make him/her sick, or put on too much weight. Don't try to make him/her finish the bottle if he/she doesn't seem to want it. Resting halfway through the feed will allow the infant to register if he/she is feeling full.

• The mother/caregiver will learn to recognise signs of hunger in the infant and it is helpful to recognise this before he/she starts crying.

• When he/she wakes they will move about and this is a good time to prepare the bottle.

• A good time to feed is when the infant starts to move his/her head about and mouth around, start to suck and may suck on their fingers

Signs that the infant is well hydrated and getting enough milk include;

• The infant should be gaining weight and be having at least 6 heavy wet nappies per day after the first few days.

• The urine should be clear or pale yellow.

• As the meconium (sticky dark stools of newborns) has passed the stools should become pale yellow or yellowish-brown. Most formula fed babies will pass at least one stool a day; however, it may be normal for some to only pass stools every 3 days. Most formula fed babies will pass at least one stool a day; however, it may be normal for some to only pass stools every 3 days.

• If the infant seems constipated check how the formula is prepared with the right scoops to water and seek advice from your Doctor or Maternal and Child Health Nurse.

Calculation of feed volume

• In a healthy full term infant the feed amount is calculated using the infant's birth weight until the infant is above birth weight and then the actual weight is used.

• The healthy full term infant will demand feed and requirements may differ slightly from day to day. The infant's growth and development is monitored by the Maternal and Child Health Nurse and the feeding regimen is assessed or altered where appropriate.

Calculating feeds

Birth-weight (grams)/1000 x ML/kg/day / Number of feeds a day = Volume per feed (approx) mls

3 hourly feeds = 8 feeds/day

4 hourly feeds = 6 feeds/day

Good bottle-feeding practice

Good practice in bottle-feeding involves making feeding a comfortable experience for parent and infant while avoiding risks associated with incorrect bottle-feeding. this includes:

• Always checking the temperature of the formula before feeding by shaking a little milk from the teat onto the inside of the wrist - it should feel warm, not hot

• Holding, cuddling and talking to (if it is not too distracting) the infant while feeding and responding to infant cues - parent-infant contact is extremely important

• Not leaving an infant to feed on their own (i.e. with the bottle propped) - the milk may flow too quickly and cause the infant to splutter or choke

• Not putting an infant to sleep while drinking from a bottle - as well as the risk of choking this increases the risk of ear infection and dental caries.

Feeding technique (education for mothers/caregivers);
1. The caregiver should cradle the baby in the arm and cuddle close holding gently but firmly.
2. The baby should be on a slight incline.
3. Stimulate the rooting reflex by brushing the teat on the lips and slide the teat into the mouth to where the sucking reflex is stimulated.
4. The neck of the bottle should be kept at an angle so it is filled with milk until the baby has finished.
5. Give half of the required feed as volumes get larger.
6. Sit baby up and gently allow to 'burp' or rest.
7. Continue with second half of feed.
8. Following feed, encourage parents to cuddle baby.
9. Never leave the baby with a bottle unattended.
10. Recommend changing the position in the arms to the other side regularly.
11. Document volume, type and feeding method (whilst an in-patient).

Advice for parents

• Put an infant to bed without a bottle or take the bottle away when the infant has finished feeding.

• Don't let the infant keep sucking on the bottle in bed.

• Avoid leaving an infant unattended with a bottle containing liquids (i.e. no bottle propping)