appropriate prescribing of specialist infant formulae: a ... infant formulae... · child...

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Purpose of these guidelines These guidelines, written in conjunction with the MKUHFT paediatric dietitians, are intended to assist GP’s and health visitors on appropriate prescribing of specialist infant formulae for five specific conditions. For some of the conditions the guidance enables management within primary care, for others specialist paediatrician/paediatric dietitian input is essential but the guidance enables better understanding and details the appropriate infant formulae that will be required. The formulary contained within this guidance, whilst complete for the five conditions covered, is not complete with regard to all specialist infant formulae. More complex medical conditions are not covered by this guidance and nor are the very specialist feeds that may be necessary in such circumstances. Breast milk remains the optimal milk for infants this should be promoted and encouraged where it is clinically safe to do so and the mother is in agreement. Contents Title Page Number(s) Cow’s Milk Protein Allergy 2 - 4 Gastro-Oesophageal Reflux Disease 5 - 7 Secondary Lactose Intolerance 8 - 9 Faltering Growth 10 Pre-Term Infants 11 Formulary (including how much to prescribe) 12 - 13 Appendix 1 The MAP GUIDELINE Milk Allergy in Primary Care (Algorithm) Identifying the Type and Severity of Milk Allergy 14 Appendix 2 The MAP GUIDELINE Milk Allergy in Primary Care (Algorithm) Primary Care Management of Mild to Moderate Non-IgE Mediated CMA 15 Appendix 3 Further Information Relating to Safeguarding Children 16 References 17 Safeguarding children Child maltreatment can result in or co-exist with other health problems. If at any time when working with a child and family you as a professional have concerns about the safety or wellbeing of a child or if you are concerned that a child has suffered or is at risk of suffering significant harm, Children’s Social Care must be contacted. This is done through the Milton Keynes Multi-Agency Safeguarding Children Hub (MASH), the single point of contact for concerns about children and young people in Milton Keynes. For contact details and further information please see Milton Keynes CCG Website: http://www.miltonkeynesccg.nhs.uk/safeguarding-children/ Appropriate Prescribing of Specialist Infant Formulae: A Guide for Healthcare Professionals in Primary Care (Adapted from guidance written by Central Eastern Commissioning Support Unit Medicines Management Team and PrescQIPP (Bulletin 67, July 14, 2.2)

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Page 1: Appropriate Prescribing of Specialist Infant Formulae: A ... Infant Formulae... · Child maltreatment can result in or co-exist with other health problems. If at any time when working

Purpose of these guidelines

These guidelines, written in conjunction with the MKUHFT paediatric dietitians, are intended to assist GP’s and health visitors on appropriate prescribing of specialist infant formulae for five specific conditions. For some of the conditions the guidance enables management within primary care, for others specialist paediatrician/paediatric dietitian input is essential but the guidance enables better understanding and details the appropriate infant formulae that will be required.

The formulary contained within this guidance, whilst complete for the five conditions covered, is not complete with regard to all specialist infant formulae. More complex medical conditions are not covered by this guidance and nor are the very specialist feeds that may be necessary in such circumstances.

Breast milk remains the optimal milk for infants – this should be promoted and encouraged where it is clinically safe to do so and the mother is in agreement.

Contents

Title

Page Number(s)

Cow’s Milk Protein Allergy

2 - 4

Gastro-Oesophageal Reflux Disease

5 - 7

Secondary Lactose Intolerance

8 - 9

Faltering Growth

10

Pre-Term Infants

11

Formulary (including how much to prescribe)

12 - 13

Appendix 1 The MAP GUIDELINE – Milk Allergy in Primary Care (Algorithm) Identifying the Type and Severity of Milk Allergy

14

Appendix 2 The MAP GUIDELINE – Milk Allergy in Primary Care (Algorithm) Primary Care Management of Mild to Moderate Non-IgE Mediated CMA

15

Appendix 3 Further Information Relating to Safeguarding Children

16

References

17

Safeguarding children

Child maltreatment can result in or co-exist with other health problems. If at any time when working with a child and

family you as a professional have concerns about the safety or wellbeing of a child or if you are concerned that a child

has suffered or is at risk of suffering significant harm, Children’s Social Care must be contacted. This is done through

the Milton Keynes Multi-Agency Safeguarding Children Hub (MASH), the single point of contact for concerns about

children and young people in Milton Keynes. For contact details and further information please see Milton Keynes

CCG Website: http://www.miltonkeynesccg.nhs.uk/safeguarding-children/

Appropriate Prescribing of Specialist Infant Formulae: A Guide for Healthcare Professionals in Primary Care

(Adapted from guidance written by Central Eastern Commissioning Support Unit Medicines Management Team and PrescQIPP (Bulletin 67, July 14, 2.2)

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This guidance has been adapted from The MAP guideline (Milk Allergy in Primary Care) - http://www.ctajournal.com/content/3/1/23. Refer also to Appendices 1 & 2 of this guidance for diagnosis and management flow charts from the MAP guideline.

Symptoms and diagnosis

1) Establish whether the suspected allergy is IgE or Non IgE mediated and its severity:

**CMP = Cow’s Milk Protein

Non-IgE Mediated CMA “Delayed” Onset Symptoms

Mostly 2-72 hrs after ingestion of CMP**

IgE Mediated CMA “Acute” Onset Symptoms & if severe ANAPHYLAXIS

Mild to Moderate

Mostly within minutes of

ingestion of CMP**

One or more of these symptoms:

Skin

Acute pruritus, erythema, urticaria, angioedema, acute flaring of atopic

eczema

Gastrointestinal Vomiting, diarrhoea, abdominal pain/colic

Respiratory

Acute rhinitis &/or conjunctivitis

REFERRAL

Urgent referral to paediatrician

Refer to dietitian

Severe

ANAPHYLAXIS

Immediate reaction

with severe respiratory &/or CVS signs &

symptoms

(Rarely a severe gastrointestinal presentation)

Emergency Treatment & Admission

Mild to Moderate

One/often more than one

of these symptoms:

Gastrointestinal Colic, vomiting, reflux, GORD, food refusal or

aversion, loose or frequent stools, perianal redness, constipation, abdominal discomfort, blood &/or mucus in

stools in an otherwise well infant

Skin

Pruritus, erythema, significant atopic eczema

Respiratory

Catarrhal airway symptoms (usually in

combination with one or more of the above

symptoms)

REFERRAL Can be managed in primary care but referral to paediatrician/dietitian may be needed if symptoms don’t settle or if considering reintroducing cow’s milk/ standard formula

Severe

SEVERE persisting symptoms of one or

more of:

Gastrointestinal Diarrhoea, vomiting, abdominal pain, food refusal or aversion,

significant blood &/or mucus in stools,

irregular or uncomfortable stools +/- faltering growth

Skin

Severe atopic eczema +/- faltering growth

REFERRAL

Urgent referral to paediatrician

Urgent Referral to dietitian

Further guidance on undertaking an allergy-focussed clinical history can be found via the following link: http://www.nice.org.uk/guidance/cg116/chapter/1-Guidance

2) Refer to paediatrician and paediatric dietitian (in accordance with above table)

Cow’s Milk (Protein) Allergy (CMA)

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Treatment

If breastfeeding, advise cow’s milk free maternal diet (a cow’s milk free diet sheet for mum can be found on: https://www.bda.uk.com/foodfacts/milkallergy ) & prescribe maternal supplements of Calcium 1000mg & Vitamin D 10mcg daily - e.g. Calceos (Galen Ltd) or Calcichew-D3 (Takeda UK Ltd) – 1 tablet bd. Strict cow’s milk free diet for infant if weaning has commenced.

If formula fed/mixed feeding, prescribe formula in accordance with below & advise strict cow’s milk free diet for infant if weaning has commenced. Initially trial a 1 month acute prescription - see page 13 for amounts.

Type/Severity of

CMA Product to Prescribe, Tin Size* & Age Range

(*for amounts to prescribe see page 13)

Comments/Indications

Mild/Moderate CMA (IgE and Non-IgE

mediated)

1st

Line (primary care) Extensively Hydrolysed Formula (EHF):

Birth to 6 months: Similac Alimentum 400g (Abbott)

6 months to 2 years: Nutramigen 2 with LGG 400g (Mead Johnson)

At age 6 months essential to switch to Nutramigen 2 with LGG as vitamin and mineral profile better matches need from 6 months onwards

2nd

Line (primary care) If child won’t tolerate taste of 1

st line product

Extensively Hydrolysed Formula (EHF):

Birth to 2 years: SMA Althera 450g (Nestle)

SMA Althera contains lactose

EHF have a bitter taste. It is essential that parents persevere

with 1st line options for a

minimum of 2-4 weeks, after which time the child will start to

settle and show some improvement.

If child fails to improve/ tolerate 1st & 2

nd line after 2-4 weeks trial/known lactose intolerance

preventing trial of 2nd

line EHF, make urgent referral to paediatric dietitians and consider trial of Amino Acid Formula (see below) in interim

Other EHF to be started in secondary care/on advice of paediatric dietitian only:

Birth to 2 years: Pregestimil Lipil 400g (Mead Johnson) (lactose free)

Birth to 2 years: Pepti-Junior 450g (Cow & Gate) (contains residual lactose)

CMA accompanied by malabsorption

Severe CMA (IgE and Non-IgE

mediated) Children prescribed AAF should continue to be under the care

of a paediatric dietitian – if found otherwise, please

refer to them

Amino Acid Formulae (AAF) – can be initiated in primary care for Severe CMA but immediate referral

needed to secondary care:

Birth to 2 years (either):

Nutramigen Puramino 400g (Mead Johnson)

Neocate LCP 400g (Nutricia)

CMA +/- severe allergic reactions/has not tolerated

EHF/or if formula top ups are needed for child otherwise breast

fed (mum on milk free diet).

The following Amino Acid Formulae (AAF) are highly specialist products and should only be used/initiated

by secondary/tertiary care:

Neocate Active 15x63g (Nutricia)

Neocate Advance 10x100g/15x50g (Nutricia)

Neocate Junior 400g (Nutricia)

Neocate Spoon 15x37g (Nutricia) (All over age 1 yr)

Neocate Active is not suitable as a sole source of nutrition

Neocate Advance/Neocate Junior are suitable as a sole source of nutrition for CMA for children 1-10years – children with severe

allergies may require a prescription past age 2 years but always at the recommendation of

& monitoring by a paediatric dietitian

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Important notes

Don’t recommend lactose free formulae (e.g. SMA LF, Enfamil O-Lac) as these still contain cow’s milk protein.

Don’t routinely recommend soya formula (SMA Wysoy) due to its phytoestrogen content – it should not be recommended at all for those under 6 months.

Don’t suggest milk and formulae made from goat’s/sheep’s or other mammalian milk as these are not suitable.

Rice milk is NOT suitable for those under 5yrs of age due to arsenic content.

Review and discontinuation of treatment

1) For the 1st line option (Extensively Hydrolysed Formula) started in primary care, review after the initial 1 month

trial to ensure tolerance and switch to ongoing monthly prescriptions – see page 13 for amounts. Refer to the above table for further guidance if the 1

st line option is not tolerated.

2) The paediatrician/paediatric dietitian will advise when it is appropriate to stop the specialised formulae.

3) For mild to moderate non-IgE mediated CMA it may be possible to trial a reintroduction of cow’s milk containing foods in primary care – refer to Appendix 2 and also below.

If you have established the child has mild to moderate non-IgE mediated CMA but is able to eat some foods containing cow’s milk:

If the child has mild to moderate non-IgE mediated CMA and is able to eat any of the following foods – cow’s milk, cheese, yoghurt, ice cream, custard, chocolate, cakes, cream, butter, margarine, ghee – this would suggest there is some tolerance to cow’s milk.

Refer to the Milk Ladder Diet Sheet (available from the MK Formulary website) for guidance on a graduated trial of foods containing cow’s milk.

The Milk Ladder Diet Sheet explains the circumstances under which this is safe and appropriate.

If the decision is made to progress with the Milk Ladder, switch the prescribed formula to an acute prescription (if on repeat) and review in 2 months or sooner if clinical concern.

After 2 months if the child has difficulty progressing with the milk ladder, refer to paediatric dietitian.

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Symptoms and diagnosis

Gastro oesophageal reflux (GOR)

The passage of gastric contents into the oesophagus, which may result in effortless regurgitation of feeds/vomiting.

It is very common and does not routinely need further investigation or treatment in normal, healthy infants.

Gastro oesophageal reflux disease (GORD)

Diagnosed when symptoms become severe enough to warrant medical treatment, i.e., frequent, effortless regurgitation/vomiting (not projectile) of a significant volume of feed and marked distress/crying at feed times.

This may also result in small volumes of feed being taken and a general reluctance to feed.

GOR and GORD generally present in the first 6 months of life and usually resolve by 12/15 months of age.

Before proceeding to the treatment section on the next page, ensure no ‘red flag’ symptoms* indicating more serious conditions that could require urgent hospital assessment – refer to the table below (from: http://www.nice.org.uk/guidance/ng1 ):

‘Red flag’ symptoms*

Possible diagnostic implications

Suggested actions

Gastrointestinal

Frequent, forceful (projectile) vomiting

May suggest hypertrophic pyloric stenosis in infants up to 2 months old

Paediatric surgery referral

Bile-stained (green or yellow-green) vomit

May suggest intestinal obstruction Paediatric surgery referral

Heamatemesis (blood in vomit) with the exception of swallowed blood, e.g. following nose bleed or ingested blood from cracked nipple in some breast-fed infants

May suggest an important & potentially serious bleed from the oesophagus, stomach or upper gut

Specialist referral

Onset of regurgitation &/or vomiting after 6 months or persisting after 1 year

Late onset suggests a cause other than reflux, e.g. urinary tract infection (also see NICE guideline on UTI in under 16s)

Persistence suggests an alternative diagnosis

Urine microbiology investigation

Specialist referral

Blood in stool May suggest variety of conditions including bacterial gastroenteritis, infant *cow’s milk (protein) allergy (CMA) or an acute surgical condition

Stool microbiology

Specialist referral

See pages 2-4 of this guidance for *CMA

Abdominal distention, tenderness or palpable mass

May suggest intestinal obstruction or other acute surgical condition

Paediatric surgery referral

Chronic diarrhoea May suggest *cow’s milk (protein) allergy (CMA) See pages 2-4 of this guidance for *CMA

Systemic

Appearing unwell Fever

May suggest infection (also see NICE guideline on fever in under 5s)

Clinical assessment & urine microbiology investigation

Specialist referral

Dysuria May suggest urinary tract infection (also see NICE guideline on UTI in under 16s)

Clinical assessment & urine microbiology investigation

Specialist referral

Bulging fontanelle May suggest raised intracranial pressure, e.g. due to meningitis (also see NICE guideline on meningitis (bacterial) & meningococcal septicaemia in under 16s)

Specialist referral

Gastro-Oesophageal Reflux Disease

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‘Red flag’ symptoms*

Possible diagnostic implications

Suggested actions

Rapidly increasing head circumference (more than 1cm per week)

Persistent morning headache, & vomiting worse in the morning

May suggest raised intracranial pressure, e.g. due to hydrocephalus or a brain tumour

Specialist referral

Altered responsiveness for example, lethargy or irritability

May suggest an illness such as meningitis (also see NICE guideline on meningitis (bacterial) & meningococcal septicaemia in under 16s)

Specialist referral

Infants and children with, or at high risk of, atopy

May suggest *cow’s milk (protein) allergy (CMA) See pages 2-4 of this guidance for *CMA

Treatment (in the absence of ‘red flag’ symptoms*) - either A, B or C below A. For infants presenting with GOR, reassure parents/carers that it is very common and will resolve over time

without the need for treatment/further investigation. Advise them to return if any new concerns present.

B. In breast-fed infants with frequent regurgitation/vomiting and marked distress, refer to the family health

visitor for a breast feeding assessment. If symptoms do not resolve, consider alginate therapy for 1-2 weeks. If the alginate therapy is successful, continue with it but trial stopping it at intervals to see if GORD has resolved.

C. In formula fed infants with frequent regurgitation/vomiting and marked distress, use the following stepped

care approach (also found in NICE Guidance http://www.nice.org.uk/guidance/ng1):

Reduce the total feed volumes only if excessive for the infant’s weight (around 150ml/kg daily), recommend a trial of smaller, more frequent feeds (the family health visitor may be able to provide support for this). If this fails:

Product Including Age Range

Comments/Indications

Over the Counter Products for formula fed infants – to be used as part of the stepped care approach (prior to considering prescribing):

Birth to 1 year: Cow & Gate Anti-Reflux 900g (C&G)

Birth to 1 year: Aptamil Anti-Reflux 900g (Milupa)

Over the counter (OTC) products must be recommended initially – these are thickened formulae and will require a large whole(fast flow) teat

Thickening Formula for formula fed infants which can be prescribed if OTC products do not improve symptoms:

Birth to 1 year: Enfamil AR 400g (Mead Johnson) (contains rice starch)

*for amounts to prescribe see page 13

This thickens in the stomach and does not require a large whole (fast flow) teat Make with fridge cooled, pre-boiled water in accordance with instructions on the tin.

If the infant is prescribed a specialist feed (e.g. pre-term or high energy formula), secondary care may ask for a thickener (e.g. Carobel) to be added to the specialist feed, as there are no alternative thickened specialist feeds for these

Do not prescribe alginate therapy or omeprazole with above – refer to NICE Guideline – above should be trialled first before below:

If Over the Counter, followed by Thickening Formulae unsuccessful: 2

nd Line – Alginate Therapy (Primary Care):

STOP thickening formula.. & return to standard formula

Prescribe: Gaviscon Infant Sachets Each half of dual sachet = 1 dose (to avoid errors, prescribe with directions in terms of “dose”) Alginate therapy (due to sodium content) should not be given more than 6 times in 24 hours, or where the infant has diarrhoea or a fever.

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Onward referral

1) Infants with faltering growth should be referred to paediatric services without delay.

2) If symptoms do not improve one month after commencing treatment, refer to a paediatrician for further investigations.

If the stepped care approach and alginate therapy fail to improve symptoms and there is a family history of atopy, consider cow’s milk protein allergy (CMA).

Review and discontinuation of treatment

1) Once weaning is established, particularly from around 6 months of age, symptoms may significantly resolve. Review every 3 months and trial stopping the thickened formula (or alginate therapy) to see if there is an ongoing need.

2) GORD will naturally resolve by about 12 months of age, and the infant should no longer need the thickened formula/alginate therapy at that time.

3) If a parent/carer is concerned about the infant’s growth, ask the family health visitor to weigh the infant and in light of the weight and centile, consider referral to a paediatrician/paediatric dietitian.

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Symptoms and diagnosis

Usually occurs following an infectious gastrointestinal illness but may present alongside newly or undiagnosed coeliac disease.

Symptoms include abdominal bloating, increased (explosive) wind, loose green stools.

Lactose intolerance should be suspected in infants who have had any of the above symptoms that persist for more than 2 weeks.

Resolution of symptoms within 48 hours of withdrawal of lactose from the diet confirms diagnosis.

Treatment Breast fed infants should continue to be fed as normal. No change to the maternal diet is required as lactose

levels cannot be altered by changing the mother’s diet.

For formula fed infants, advise parent to use a low lactose/lactose free formula for 4-8 weeks to allow symptoms to resolve. Rarely symptoms may last up to 3 months.

In infants who have been weaned, a low lactose/lactose free formula should be used in conjunction with a lactose free diet.

In children over 1 year who previously tolerated cow’s milk, low lactose/lactose free formulae are not indicated. Suggest use of lactose free products, e.g. full fat lactose free cow’s milk and lactose free yoghurt, which can be purchased from supermarkets.

Formulae

1st

Line – Lactose Free Formulae - These formulae must be purchased over the counter – do not prescribe

SMA LF 430g (SMA)

Enfamil O-Lac 400g (Mead Johnson)

(Both products appropriate from birth to 2 years)

If previously tolerated cow’s milk, recommend purchase lactose free cow’s milk from age 1 year onwards

2nd

Line (if 1st

line products not tolerated) - Soya Formula - This must be purchased over the counter – do not prescribe

SMA Wysoy 430g/860g(SMA)

This should not be routinely used for secondary lactose intolerance.

This should not be used at all for infants under 6 months due to phytoestrogen content.

Review and discontinuation of treatment 1) After 4-8 weeks ask the parent to challenge with a standard cow’s milk based infant formula – trial a

graduated introduction by mixing it with low lactose/lactose free formula. Make up each bottle on the following basis:

First 2 days ¼ standard cow’s milk based formula + ¾ low lactose formula

Next 2 days ½ standard cow’s milk based formula + ½ low lactose formula

Next 2 days ¾ standard cow’s milk based formula + ¼ low lactose formula

Thereafter use standard cow’s milk based formula entirely to make up bottles

2) If symptoms persist, revert to the low lactose/lactose free formula and re-challenge 2 weeks later. (If the infant is not feeding well, their brush border will take longer to regrow and enable production of the lactase enzyme.)

3) In infants who have been weaned, provided the above is tolerated, reintroduce cow’s milk containing foods (over 6 months of age) into the diet.

4) In children over 1 year: Trial a graduated introduction of cow’s milk over 7 days and provided this is tolerated, there is no need to continue with a lactose free diet.

Secondary Lactose Intolerance

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Onward referral

1) If the infant/child fails to tolerate the reintroduction of lactose and appears to require a lactose free diet in the longer term, please provide the Information on Lactose Intolerance Diet Sheet and Sources of Calcium for a Cow’s Milk Free Diet Sheet (available from the MK Formulary website).

2) If there are additional nutritional issues/concerns, please see the Paediatric Dietetic Referral Criteria (available from the MK Formulary website).

Notes

Primary lactose intolerance is less common than secondary lactose intolerance and does not usually present until later childhood or adulthood.

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Symptoms and diagnosis

Diagnosis is made when growth of the infant falls below the 0.4th centile or crosses 2 centiles downwards on a

growth chart or weight is 2 centiles below length centile.

The height/length of an infant should be measured to properly interpret changes in weight using appropriate growth charts to be able to diagnose.

It is essential to rule out possible disease related/medical causes for the faltering growth e.g. iron deficiency anaemia, constipation, GORD or a safeguarding issue. If identified, appropriate action should be taken.

Onward referral

1) Refer immediately to a paediatrician.

2) Refer to a paediatric dietitian for advice on a high energy, high protein diet.

Treatment

High Energy Formulae to be started in secondary care/ on advice of paediatric dietitian:

SMA PRO High Energy 200 ml (SMA) Birth to 6 months - suitable to 18months in conjunction with solid food

Similac High Energy 60/200ml (Abbott) Birth to 18 months or 8kg

Infatrini Peptisorb 200ml (Nutricia) Birth to 18 months or 8kg

Infatrini Peptisorb = High energy extensively hydrolysed formula

Review and discontinuation of treatment

1) The team to whom the infant is referred should indicate who is responsible for review and discontinuation. If the team hand responsibility back to the GP, they should include clear guidance as to the treatment goal(s), and at what point discontinuation can occur.

2) All infants on high energy formula will need growth (weight and height/length) monitored to ensure catch up growth occurs - discuss this with the family health visitor to arrange monitoring.

3) Once this is achieved, the formula should be discontinued to minimise excessive weight gain.

Notes

Where all nutrition is provided via an enteral feeding tube, the paediatric dietitian will advise on appropriate monthly amounts of formula required, which may exceed the guideline amounts for other infants.

Faltering Growth in Infants

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Indications The feed of choice for all infants, including pre-term infants, is breast milk. Every effort will be made to support mum to

breastfeed. However, in some circumstances it may not be possible to solely breastfeed or breastfeeding may not be

possible at all. In these circumstances a pre-term formula will be necessary.

Pre-term formula is usually used for babies born before 35 weeks gestation &/or weighing less than 2kg at birth.

Pre-term formula should only be prescribed to promote weight gain in babies born prematurely.

Initially mum may be discharged home breastfeeding her pre-term infant(s) but if breastfeeding is no longer possible in part or entirely then a prescription may be necessary for a pre-term formula.

Pre-Term Infant Formulae to be started in secondary care/ on advice of paediatric dietitian:

Powder Pre-Term Formulae: Nutriprem 2 Powder 900g (Cow & Gate)

SMA PRO Gold Prem 2 Powder 400g (SMA)

Liquid Pre-Term Formulae: Nutriprem 2 Liquid 200ml (Cow & Gate)

SMA PRO Gold Prem 2 Liquid 200ml (SMA)

Birth to maximum 6 months corrected age 6 months corrected age = expected date of delivery + 26 weeks

On discharge from the Neonatal Unit, a short term prescription will be requested for both the liquid and powder pre-term formulae. After a month post discharge liquid pre-term formulae should not be routinely prescribed unless there is a clinical need – e.g. immunocompromised.

Onward referral

1) These infants should already be under regular review by the paediatricians.

2) If there are concerns regarding growth whilst the infant is on these formulae, refer to the paediatric dietitian (unless you have received notification that the paediatric team have already made a referral to the dietitians).

3) If there are concerns regarding growth at 6 months corrected age, or at review one month after these formulae are stopped, refer to the paediatric dietitian.

Review and discontinuation of treatment

1) The health visitor &/or community neonatal nurses should monitor growth (weight, length and head circumference) while the baby is on these formulae.

2) These formulae should be discontinued by 6 months corrected age.

6 months corrected age is EDD (Expected Date of Delivery) + 26 weeks

3) Not all babies need these formulae for the full 26 weeks from expected date of delivery.

4) If there is excessive weight gain at any age up to 6 months corrected age, stop the formula.

5) Once the pre-term formula is stopped, switch to a standard term over the counter formula.

Pre-Term Infants

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Condition Product Product type Age Range Comments

Mild/Moderate Cow’s Milk Protein Allergy (CMA)

IgE and Non-IgE mediated

Similac Alimentum 400g (Abbott) Extensively Hydrolysed Formula (EHF) Birth to 6 mths At age 6 months essential to switch to Nutramigen 2 with LGG

Nutramigen 2 with LGG 400g (Mead Johnson)

Extensively Hydrolysed Formula (EHF) 6 mths to 2 yrs

SMA Althera 450g (Nestle) (contains lactose)

Extensively Hydrolysed Formula (EHF) Birth to 2 yrs 2nd

Line if child won’t tolerate taste of 1

st line product after 2-4 weeks trial

Pregestimil Lipil 400g (Mead Johnson)

Extensively Hydrolysed Formula (EHF) Birth to 2 yrs

To be started in secondary care/on advice of paediatric dietitian only CMA accompanied by malabsorption

Pepti-Junior 450g (Cow & Gate) (contains residual lactose)

Extensively Hydrolysed Formula (EHF) Birth to 2 yrs

Severe Cow’s Milk Protein Allergy (CMA)

IgE and Non-IgE mediated

Nutramigen Puramino 400g (Mead Johnson) or Neocate LCP 400g (Nutricia)

Amino Acid Formulae (AAF) Birth to 2 yrs Can be initiated in primary care for severe CMA but immediate referral needed to secondary care

Neocate Active 15x63g (Nutricia) Amino Acid Formula (AAF) Over 1 yr

Highly specialist products and should only be used/initiated by secondary /tertiary care

Neocate Advance 10x100g/15x50g (Nutricia)

Amino Acid Formula (AAF) Over 1 yr

Neocate Junior 400g (Nutricia) Amino Acid Formula (AAF) Over 1 yr

Neocate Spoon15x37g (Nutricia) Amino Acid Formula (AAF) Over 1 yr

Gastro Oesophageal Reflux Disease (GORD)

Cow & Gate Anti-Reflux 900g (C&G) or Aptamil Anti-Reflux 900g (Milupa)

Over the Counter Thickened Formulae Birth to 1 yr These formulae must be purchased over the counter – prior to considering prescribing below

Enfamil AR 400g (Mead Johnson) (contains rice starch)

Thickening Formula Birth to 1 yr Next step if OTC products do not improve symptoms

Do not prescribe alginate therapy or omeprazole with above – refer to NICE Guideline – above should be trialled first before below:

Gaviscon Infant Sachets (Alginate Therapy): STOP thickening formulae & return to standard formula. Each half of dual sachet = 1 dose (to avoid errors, prescribe with directions in terms of “dose”) Alginate therapy (due to sodium content) should not be given more than 6 times in 24 hours, or where the infant has diarrhoea or a fever.

Secondary Lactose Intolerance If previously tolerated cow’s milk, recommend purchase lactose free cow’s milk from age 1 year onwards

SMA LF 430g (SMA) or

Enfamil O-Lac 400g (Mead Johnson)

1st Line – Lactose Free Formulae Birth to 2 yrs These formulae must be purchased

over the counter – do not prescribe

SMA Wysoy 430g/860g (SMA)

2nd

Line - Soya Formula – do not routinely use Do not use at all for infants under 6 months

This formula must be purchased over the counter – do not prescribe

Faltering Growth SMA PRO High Energy 200 ml (SMA) High Energy Formula Highly specialist products only to be started in secondary care/ on advice of paediatric dietitian

Similac High Energy 60/200ml (Abbott)

High Energy Formula

Infatrini Peptisorb 200ml (Nutricia) High Energy EHF

Pre-Term Infants Nutriprem 2 Powder 900g (C&G) Powder Pre-Term Infant Formula

Birth to maximum 6 months

corrected age

To be started in secondary care/ on advice of paediatric dietitian After a month post discharge liquid pre-term formulae should not be routinely prescribed

SMA PRO Gold Prem 2 Powder 400g Powder Pre-Term Infant Formula

Nutriprem 2 Liquid 200ml (C&G) Liquid Pre-Term Infant Formula SMA PRO Gold Prem 2 Liquid 200ml Liquid Pre-Term Infant Formula

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Formulary

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Quantities of formulae to prescribe

The information below is intended as a general guide to cater for most infants/children. If overfeeding is suspected, refer to the family Health Visitor for a feeding assessment. If the paediatrician/paediatric consultant/dietitian has requested different quantities, please follow their recommendation rather than the quantities stated below. The rationale will be included within their feed request. For powdered formula:

Age of child Initial Trial (Acute Prescription)

No tins required per month

Up to 3 months

8 x 400-450g tins Or 4 x 800-900g tins

8-10 x 400-450g tins Or 4-5 x 800-900g tins

3-6 months

10 x 400-450g tins Or 5 x 800-900g tins

10-12 x 400-450g tins Or 5-6 x 800-900g tins

6-9 months

10 x 400-450g tins Or 5 x 800-900g tins

10 x 400-450g tins Or 5 x 800-900g tins

9-12 months

7 x 400-450g tins Or 3 x 800-900g tins

7 x 400-450g tins Or 3-4 x 800-900g tins

1-2 years

7 x 400-450g tins Or 3 x 800-900g tins

7 x 400-450g tins Or 3-4 x 800-900g tins

For liquid formula (specialist advice needed from secondary/tertiary care):

Liquid formula preparations consist of either high energy formulae or pre-term infant formulae.

For any liquid formula preparations, please follow the recommendations made by the dietitian/paediatrician/consultant.

These should not be initiated in primary care in the absence of specific guidance from secondary/tertiary care particular to the patient. Please contact the dietitian in the first instance in the absence of such guidance.

The formulary contained within this guidance, whilst complete for the five conditions covered, is not complete with regard to all specialist infant formulae. More

complex medical conditions are not covered by this guidance and nor are the very specialist feeds that may be necessary in such circumstances.

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Appendix 1

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Appendix 2

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Safeguarding children – additional information

Safeguarding is the action we take to promote the welfare of children and protect them from harm and it is everyone’s

responsibility. Everyone who comes into contact with children and families has a role to play (Working Together to

Safeguard Children: A guide to inter-agency working to safeguard and promote the welfare of children, HM

Government, 2015).

Professionals in any agency who work with children and/or adults who have parenting responsibilities share a

commitment to safeguard and promote the welfare of children. Professionals have a responsibility to make sure they

are equipped with the appropriate level of knowledge and support to be able to judge when they need to seek further

information about a child’s circumstances or need to seek advice from mangers, their designated safeguarding lead or

another agency.

The Milton Keynes Safeguarding Children Board document “Levels of need when working with children and their

families” (2015) provides guidance to professionals in identifying signs of abuse and neglect.

Child maltreatment can result in or co-exist with other health problems. If at any time when working with a child and

family you as a professional have concerns about the safety or wellbeing of a child or if you are concerned that a child

has suffered or is at risk of suffering significant harm, Children’s Social Care must be contacted. This is done through

the Milton Keynes Multi-Agency Safeguarding Children Hub (MASH), the single point of contact for concerns about

children and young people in Milton Keynes.

It is important as a professional that you also seek advice and support from your agency’s safeguarding lead and

adhere to your agency’s safeguarding policy, which should be read in conjunction with the Milton Keynes

Safeguarding Children Board’s policy and procedures.

Policies, guidance documents and contact details can be found on Milton Keynes CCG Website: http://www.miltonkeynesccg.nhs.uk/safeguarding-children/

Appendix 3

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First Steps Nutrition Trust (February 2016), Infant Milks: A simple guide to infant formula, follow-on formula and other infant milks

PrescQIPP Bulletin 67 (July 2014) 2.2, Appropriate prescribing of specialist infant formulae (adapted from guidance written by Central Eastern Commissioning Support Unit Medicines Management Team)

Venter et al (2013) “Diagnosis and management of non-IgE mediated cow’s milk allergy in infancy – A UK primary care practical guide” Clinical and Transitional Allergy. 3:23. Found at: http://www.ctajournal.com/content/3/1/23 National Institute for Health & Care Excellence (2011) Clinical Guideline 116: Food Allergy in children and young people: Diagnosis and assessment of food allergy in children and young people in primary care and community settings. Found at: http://www.nice.org.uk/guidance/cg116/chapter/1-Guidance National Institute for Health & Care Excellence (2015) NICE Guideline 1: Gastro-oesophageal reflux disease in children and young people: diagnosis and management (NG1). Available at: http://www.nice.org.uk/guidance/ng1

Approved by MKPAG July 2017. Review Date July 2019. Ruth Hammond, Prescribing Team Dietitian

References