appropriate prescribing of specialist infant formulae: a

19
Author: Jane Stanger, Dietitian Approved: MKPAG July 2020 Review: Every 2 years 1 July 2020 Contents Page Introduction and volumes to prescribe 2 Cow’s Milk Allergy 3-5 Gastro-Oesophageal Reflux Disease 6-7 Lactose Intolerance 8-9 Faltering Growth 10-11 Pre-Term Infants 12-13 Summary guide to specialist infant formula prescribing and purchase only formula 14-16 Acknowledgements 18 Useful sources of information and references 17-18 Appendix 1 Further Information Relating to Safeguarding Children 19 Appropriate Prescribing of Specialist Infant Formulae: A Guide for Healthcare Professionals in Primary Care

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Page 1: Appropriate Prescribing of Specialist Infant Formulae: A

Author: Jane Stanger, Dietitian Approved: MKPAG July 2020 Review: Every 2 years

1

July 2020

Contents Page

Introduction and volumes to prescribe 2

Cow’s Milk Allergy 3-5

Gastro-Oesophageal Reflux Disease 6-7

Lactose Intolerance 8-9

Faltering Growth 10-11

Pre-Term Infants 12-13

Summary guide to specialist infant formula prescribing and purchase only formula

14-16

Acknowledgements 18

Useful sources of information and references 17-18

Appendix 1 Further Information Relating to Safeguarding Children

19

Appropriate Prescribing of Specialist Infant Formulae:

A Guide for Healthcare Professionals in Primary Care

Page 2: Appropriate Prescribing of Specialist Infant Formulae: A

Author: Jane Stanger, Dietitian Approved: MKPAG July 2020 Review: Every 2 years

2

Introduction: ____________________________________________________________________________________

Whilst these guidelines advise on appropriate prescribing of specialist infant formulae, 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. This guideline aims to provide information to GP’s and Health Visitors on the use of prescribable infant formulae. It provides guidance on initial and on-going prescribing and when to discontinue prescribing.

The guideline covers formula that can be prescribed from birth to 1 year of age. Some conditions may require formula to be prescribed beyond this age and will be referenced under ‘Review’.

The guideline covers 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.

Specific exceptions:

If all nutrition is received by a feeding tube e.g. Nasogastric/Nasojejunal/Gastrostomy tube for clinical reasons (such as unsafe swallow), a dietitian will recommend a prescription for the appropriate monthly amount and type of formula. A dietitian may calculate a different volume or suggest the use of a formula outside these guidelines based on individual need. The specific need and clinical rationale will be included with the feed prescription request.

Volumes of feed to prescribe infants:

Please use the guide below to estimate quantity of powdered infant formula to prescribe. Volumes stated are the maximum that are required for an average child (on the 50th percentile for weight); however those under the care of a dietitian may require more or less formula. Over prescribing can occur if infants are being overfed. If you suspect an infant is being overfed or a parent requires support on responsive feeding refer to the health visiting team for assessment.

Initially prescribe, as an acute prescription, a 1-week trial of 2 x 400g or 2 x 450g tins

or 1 x 800g tin of powdered infant formula to see if the infant will accept it; then prescribe the following thereafter:

Age of infant Number of tins for 28 days

Under 6 months 10 x 400g OR 9 x 450g tins OR 6 x 800g tins

Between 6 – 12 months 7 x 400g tins OR 6 x 450g tins

Over 1 year 7 x 400g OR 6 x 450g tins OR other as stated on prescription request from paediatric dietitian

Page 3: Appropriate Prescribing of Specialist Infant Formulae: A

Author: Jane Stanger, Dietitian Approved: MKPAG July 2020 Review: Every 2 years

3

Cow’s milk allergy (CMA) ___________________________________________________________________ DIAGNOSIS:

Cow’s milk allergy (CMA) may be suspected or diagnosed after taking an allergy focused clinical history as outlined in NICE clinical guideline NG116: Food allergy in children and young people (2011) find here.

Refer to MAP guideline (2019) for clinical advice on diagnosing and managing cow’s milk allergy in primary care find here. Summary can be found below:

Mild to Moderate Non-IgE mediated CMA Severe Non-IgE mediated CMA Mild to Moderate IgE-mediated CMA

Mostly 2-72 hours after ingestion of cow’s milk

protein. Usually formula fed, at onset of formula feeding. Rarely in exclusively breast-fed infants. Usually several of these symptoms will be present. Symptoms persisting despite first line measures are more likely to be allergy related e.g. to atopic dermatitis or reflux.

Gastrointestinal

Persistent irritability - ‘colic’ Vomiting - ‘reflux’(GORD) Food refusal or aversion Diarrhoea like stools - abnormally loose +/- more frequent Constipation - especially soft stools with excessive straining Abdominal discomfort, painful flatus, blood and/or mucous in stools in otherwise well infant. Skin

Pruritus (itching), erythema (flushing), non-specific rashes Moderate persistent atopic dermatitis TREATMENT SUMMARY: Exclusively breastfeeding mother

Trial strict exclusion of all cow’s milk protein from her own diet for 2-4 weeks and advise to take daily calcium and vitamin D supplement. Formula-fed or ‘mixed feeding’ (breast and formula)

Encourage and support return to breast feeding. If mother unable to revert to fully breastfeeding, trial Extensively Hydrolysed Formula using first

line choice for 2-4 weeks.

Mostly 2-72 hours after ingestion of

cow’s milk protein. Usually formula fed, at onset of mixed feeding. Rarely in exclusively breast-fed infants. One but usually more of these severe, persisting and treatment resistant symptoms: Gastrointestinal

Diarrhoea, vomiting, abdominal pain, food refusal or food aversion, significant blood and/or mucous in stools, irregular or uncomfortable stools +/- faltering growth Skin

Severe atopic dermatitis +/- faltering growth TREATMENT SUMMARY: Exclusively breastfeeding mother

Trial strict exclusion of all cow’s milk protein from her own diet for 2-4 weeks and advise to take daily calcium and vitamin D supplement. Formula-fed or ‘mixed feeding’

If mother unable to revert to fully breastfeeding, trial of replacement of cow’s milk formula with amino acid formula using first line choice. If infant

asymptomatic on breast feeding alone, do not exclude cow’s milk from maternal diet.

Mostly within minutes (may be up to 2 hours) after ingestion of cow’s milk protein. Mostly occurs in formula fed infants or at onset of mixed feeding. One or more of these symptoms:

Gastrointestinal

Vomiting, diarrhoea, abdominal pain/colic. Skin – one or more usually present

Acute pruritus, erythema, urticaria, angioedema Acute flaring or persisting atopic dermatitis. Respiratory – rarely in isolation or other symptoms

Acute rhinitis and/or conjunctivitis TREATMENT SUMMARY: Exclusively breastfeeding mother

If infant symptomatic on breast feeding alone, trial elimination of all cow’s milk protein from her own diet for 2-4 weeks and advise to take daily calcium and vitamin D supplement. If infant asymptomatic on breast feeding alone, do not exclude cow’s milk from maternal diet. Formula-fed or ‘mixed feeding’

If mother unable to revert to fully breastfeeding, trial Extensively Hydrolysed Formula using first

line choice for 2-4 weeks.

Urgent referral to paediatric

dietitian +/- local allergy service

Severe IgE symptoms

ANAPHYLAXIS

Immediate reaction with

severe respiratory

and/or CVS signs and

symptoms. (Rarely a

severe gastrointestinal

presentation)

Emergency treatment

and admission

The symptoms above are very common in

otherwise well infants or those with other

diagnoses, so clinical judgement is required. Trial

exclusion diets must only be considered if

history & examination strongly suggests CMA,

especially in exclusively breastfed infants, where

measures to support continued breastfeeding

must be taken.

Reintroduction of cow’s milk is required to confirm diagnosis. Complete home reintroduction of cow’s milk to maternal diet or reintroduction of cow’s milk formula find here. Refer to paediatric dietitian if diagnosis confirmed.

Urgent referral to local

allergy service and

paediatric dietitian

Page 4: Appropriate Prescribing of Specialist Infant Formulae: A

Author: Jane Stanger, Dietitian Approved: MKPAG July 2020 Review: Every 2 years

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Cow’s Milk Allergy (CMA) - guidance for choice of formula when mother unable to fully breastfeed

EXTENSIVELY HYDROLYSED FORMULA (EHF)

First line Extensively hydrolysed Formula (EHF) and alternative EHF

Age range Clinical guidance/notes

First line EHF: Althera (SMA)

Birth to 1-2 years

Whey based, contains lactose. To be used if mild to moderate (Non-IgE or IgE) cow’s milk allergy is suspected or diagnosed.

Second line EHF: Alimentum* (Abbott Nutrition)

Birth to 1-2 years

Casein based, lactose free. To be used if mild to moderate (Non-IgE or IgE) cow’s milk allergy is suspected or diagnosed. * Use first line in infants with severe diarrhoea/severe GI symptoms who would benefit from a lactose free formula.

AMINO ACID FORMULA (AAF) FOR SEVERE CMA Do not initiate in primary care unless severe CMA or unresponsive/partially responsive to EHF.

Amino acid formula (AAF) Age range Clinical guidance/notes

First line AAF: EleCare (Abbott Nutrition)

Birth to 2 years

To be used for treatment of severe Non-IgE mediated and severe IgE symptoms of cow’s milk allergy. Consider use if symptoms of cow’s milk allergy have not resolved on EHF following 2-4-week trial. Do not use if extensively hydrolysed formula is not accepted simply based on taste.

Other amino acid-based formulae may be initiated by secondary care including: Alfamino (SMA) Nutramigen Puramino (Mead Johnson) Neocate LCP (Nutricia) Neocate SYNEO (Nutricia)

Birth to 2 years

To be used for treatment of severe Non-IgE mediated and severe IgE symptoms of cow’s milk allergy.

SPECIALIST MILK FROM 1 YEAR These products are only to be issued on written request from a paediatric dietitian.

Specialist milk Age range Clinical guidance/notes

Neocate junior (Nutricia)

Over 1 year

Amino acid based Formula Should not be routinely prescribed at 12 months old as follow-on milk.

Nutramigen 3 (Mead Johnson)

Over 1 year

Extensively Hydrolysed Formula Should not be routinely prescribed at 12 months as follow-on milk.

OVER THE COUNTER – NOT TO BE PRESCRIBED

Soya infant formula Age range Clinical guidance/notes

SMA Wysoy (SMA Nutrition)

6 months – 1 year

Soya formula should only be used after 6 months of age and if the first line EHF is not accepted due to taste. If a child presents with suspected CMA over 1 year of age, with no growth concerns, calcium fortified nutrient enriched no added sugar plant-based milks can be purchased. However, rice milk is NOT suitable for use under 5 years of age due to arsenic content.

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Cow’s milk allergy (CMA) ___________________________________________________________________

PRACTICAL ADVICE:

EHF is the appropriate choice for vast majority of infants with cow’s milk allergy.

Try a formula for a minimum of two weeks and avoid product switching.

Two to four weeks without allergen should improve symptoms.

Both EHF and AAF are less palatable than breast milk or standard infant formulae bought over the counter and are often initially rejected.

If an infant does not tolerate taste suggest titrating with regular formula (not for infants with history of anaphylaxis or severe symptom’s). However direct switch to formula will eliminate allergen sooner.

Infant stools may change and have a green tinge. This is seen with both EHF and AAF.

Some formulae have higher sugar content. Ensure dental hygiene advice given. REVIEW CRITERIA:

EHF can be prescribed up to the age of 2 years, however, some children may tolerate a calcium fortified plant-based milk alternative over 1 year of age and their prescription formula can be stopped. Refer to the latest written correspondence from a paediatric dietitian for guidance.

All patients prescribed these formulae require a regular review by a paediatric dietitian for advice on weaning, calcium intake, challenging with cow’s milk using the milk ladder and other feeding issues relating to a restricted diet.

GP should review all existing patients’ prescription if they meet one or more of the following criteria:

Over 2 years old.

On formula for more than one year.

The quantity of formula prescribed is higher than recommended (see page 2).

Patient can eat cow’s milk containing foods (e.g. cow’s milk, yoghurt, cream, butter, cheese, ice cream, custard, margarine, ghee).

HOME REINTRODUCTION of cow’s milk to confirm or exclude the diagnosis of mild to moderate Non-IgE cow’s milk allergy:

After 2-4-week trial of cow’s milk protein exclusion has resulted in clear improvement in symptoms a home reintroduction of cow’s milk protein is needed to either confirm or exclude the diagnosis of cow’s milk allergy. This is because any clear improvement in an infant’s symptoms could be due to other factors.

On completion of 2-4 week exclusion trial, advise parents/carers to carry out home reintroduction using MAP home reintroduction guidance sheet find here.

A further prescription of specialist formula should not be given until completion of home reintroduction.

HOME REINTRODUCTION of cow’s milk should only be undertaken for those infants with

suspected mild to moderate Non-IgE cow’s milk allergy.

Page 6: Appropriate Prescribing of Specialist Infant Formulae: A

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Gastro-oesophageal reflux _________________________________________________________ DIAGNOSIS:

Gastro oesophageal reflux (GOR) and Gastro oesophageal reflux disease (GORD) generally presents in the first 6 months of life and usually starts to resolve by 12 months of age.

GOR is the passage of gastric contents into the oesophagus, which may result in effortless regurgitation of, feeds/vomiting. GOR is very common, usually beginning before the infant is eight weeks old, may be frequent, and will usually become less frequent over time (it resolves in 90% of affected infants before they are one year of age. It does not routinely need further investigation or treatment in normal, healthy infants.

Gastro oesophageal reflux disease (GORD) is diagnosed when symptoms become severe enough to warrant medical treatment, i.e. frequent, effortless regurgitation/vomiting 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.

In breastfed or formula fed infants with frequent regurgitation and marked distress take a stepped care approach as outlined in NICE guidelines NG1: Gastro-oesophageal reflux disease in children and young people: diagnosis and management (2015) find here.

In infants and young children with vomiting or regurgitation, look out for “red flags” which may indicate disorders other than GOR/GORD find here.

TREATMENT SUMMARY: Breastfed infant

Formula fed infant

1. Complete feeding assessment, advise patient to see health visitor/infant feeding advisor.

2. If frequent regurgitation associated with marked distress continues despite assessment and advice, trial alginate therapy offered on a spoon before feeds for a period of 1-2 weeks.

3. If the alginate therapy is successful continue but try stopping at intervals to see whether still required.

1. Review feeding history including checking for overfeeding and positioning.

2. Trial smaller, more frequent feeds 6-7 x day (aim to meet requirements of 150ml/kg/day).

3. If above strategies unsuccessful advise 1-2 week trial of over the counter thickened formula - DO NOT PRESCRIBE.

4. If unsuccessful stop the thickened formula and offer alginate therapy for a period of 1-2 weeks.

Review

If symptoms persist despite stepped care approach, consider pharmacological treatment (e.g. H2 antagonists), sharing risks and benefits of medication with parents (refer to NICE guidelines NG1), or a trial of cows’ milk protein exclusion (see Red Flags for CMA).

Red Flags

Red flags for possible CMA - if present, consider 2-4 weeks of cows’ milk protein exclusion (maternal if breastfed, EHF if formula fed) under dietetic guidance, before a trial of H2 antagonist:

Existing atopic disease, in particular eczema in infants.

First degree relative with food allergy or atopic disease.

More than one of the following is present: GOR/GORD, chronic loose stools, blood or mucous in stools, abdominal pain, food refusal or aversion, constipation, peri-anal redness, pallor and tiredness, faltering growth in conjunction with one or more gastrointestinal symptoms (with or without atopic eczema).

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Gastro-oesophageal reflux ___________________________________________________________________

THICKENED FORMULA - AVAILABLE OVER THE COUNTER – NOT TO BE PRESCRIBED

Formula Age range Clinical guidance/notes

Aptamil Anti-Reflux (Cow & Gate)

Birth to 1 year

Thickened formula - use single hole, fast flow teat. Contains carob bean gum. Do not use in combination with antacids or other feed thickeners.

Cow & Gate Anti-Reflux (Nutricia)

Thickened formula - use single hole, fast flow teat. Contains carob bean gum. Do not use in combination with antacids or other feed thickeners.

SMA Anti-Reflux (SMA Nutrition)

Thickened formula - may require a single hole, fast flow teat. Contains potato starch. Do not use in combination with antacids or other feed thickeners.

Enfamil AR (Mead Johnson)

Formula thickens on contact with gastric acid in baby’s stomach. Contains rice starch. Do not use in combination with antacids or other feed thickeners.

Do not use thickened formula alongside alginate therapy e.g. Gaviscon.

Thickened formulae may require the use of a fast-flow teat.

Formulae that thicken in the stomach react with stomach acids to thicken and should not be used in conjunction with separate thickeners or with medication such as ranitidine, or proton pump inhibitors.

Alternatively, prescribe infant Carobel to add to standard formula milk (this may be necessary if an infant is on a specialist infant formula) and titrate as needed.

Parents should refer to manufacturers’ guidance on how to prepare thickened formula.

Trial stopping thickened formula at regular intervals as infant likely to outgrow GORD.

REVIEW CRITERIA:

Review after one month.

Infants with GORD will need regular review to check growth and symptoms. Since GORD will usually resolve spontaneously between 12-15 months, cessation of

treatment can be trialled from 12 months.

ONWARD REFERRAL:

Infants with faltering growth as a result of GORD should be referred to paediatric services

without delay.

If symptoms do not improve one month after commencing treatment, refer to a paediatrician

for further investigations. Cow’s milk allergy (CMA) can co-exist with GORD and

treatment as for CMA may be required.

Page 8: Appropriate Prescribing of Specialist Infant Formulae: A

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Lactose intolerance ___________________________________________________________________

DIAGNOSIS:

This is a condition which occurs as a result of a deficiency of the lactase enzyme in the intestine, it is not the same as cows’ milk allergy. It usually occurs in children who were previously able to tolerate cows’ milk.

Primary lactose deficiency is less common than secondary lactose intolerance and does not usually present until after two years of age and may not fully manifest until adulthood. Primary lactose intolerance is usually diagnosed by secondary/tertiary care and management directed by them.

Secondary lactose intolerance is more commonly seen in infants and young children and usually occurs following an acute gastrointestinal illness and is usually a temporary phenomenon. Symptoms include abdominal distension, abdominal pain, increased wind and diarrhoea.

Secondary lactose intolerance should be suspected in infants who have had any of

the above symptoms that persist for more than 2 weeks. Symptoms usually start to

show improvement within 2-3 days of lactose being removed from the diet and achievement

of this confirms diagnosis.

TREATMENT SUMMARY:

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 parents to use a lactose free formula for 6-8 weeks to allow symptoms to resolve. Parents should be advised to purchase these formulae over the counter. Standard formula and/or milk products should then be slowly reintroduced to the diet according to tolerance. Rarely symptoms may last up to 3 months.

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

In children over 1 year who previously tolerated cow’s milk, lactose free formulae are not indicated. Shop bought lactose free products can be used e.g. full fat lactose free cow’s milk and lactose free yoghurt.

LACTOSE FREE FORMULA - AVAILABLE OVER THE COUNTER – NOT TO BE PRESCRIBED

Formula Age range Clinical guidance/notes

SMA LF Lactose free (SMA)

Enfamil O-Lac with LIPIL

(Mead Johnson)

Aptamil Lactose free (Nutricia)

Birth to 1 year

Formula to be purchased by family from supermarket, pharmacy or online. For children over 1-year shop bought full fat lactose free milk can be purchased by parents/carers.

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Lactose intolerance ___________________________________________________________________ REVIEW CRITERIA:

Lactose free formula should not be used for longer than 8 weeks without review and trial of discontinuation of treatment. After 6-8 weeks ask the parent to challenge with a standard cow’s milk based infant formula. Trial a graduated introduction by mixing it with lactose free formula. Make up each bottle on the following basis:

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

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

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

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

If symptoms persist, revert to the 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).

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

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.

ONWARD REFERRAL:

If symptoms have not resolved after 8 weeks on lactose free formula/lactose free diet, consider alternative diagnosis e.g. cow’s milk allergy or refer to paediatrician for further assessment.

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Faltering growth ___________________________________________________________________

DIAGNOSIS:

Guidance on diagnosing faltering growth is outlined in NICE guidelines NG75: Faltering growth: recognition and management of faltering growth in children (2017) find here.

If there is concern about faltering growth:

weigh the infant or child measure their length (from birth to 2 years old) plot the above measurements and available previous measurements on the UK WHO

growth charts find here to assess weight change and linear growth over time.

Use the following as thresholds for concern about faltering growth in infants and children:

a fall across 1 or more weight centile spaces, if birthweight was below the 9th centile a fall across 2 or more weight centile spaces, if birthweight was between the 9th and

91st centiles a fall across 3 or more weight centile spaces, if birthweight was above the 91st centile when current weight is below the 2nd centile for age, whatever the birthweight

Individual growth patterns, feeding behaviour, parental factors and any indicators of underlying illness/medical causes should be considered when assessing faltering growth and the need for high energy formulae. If it is identified that there are any safeguarding issues that could be a contributing factor to faltering growth, then appropriate action should be taken.

TREATMENT SUMMARY: Infants with faltering growth should be referred to a Paediatrician immediately.

Infants with faltering growth should be referred to a paediatric dietitian for advice on a high

energy, high protein diet and the consideration of the use of a specialist high energy infant formula.

High Energy formula - guidance for choice of formula

HIGH ENERGY FORMULA - do not initiate in primary care

Formula Age range Clinical guidance/notes

SMA High Energy (SMA Nutrition)

From birth onwards

High energy infant formula for infants with or at risk of faltering growth. Partially hydrolysed.

Similac High energy (Abbott Nutrition)

From birth onwards

High energy infant formula for infants with or at risk of faltering growth.

Infatrini (Nutricia)

From birth up to 18 months or

9kg body weight

High energy infant formula for infants with or at risk of faltering growth.

Infatrini Peptisorb (Nutricia)

From birth up to 18 months or

9kg body weight

High energy extensively hydrolysed infant formula for infants with or at

risk of faltering growth/malabsorption.

Contains MCT.

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Faltering growth ___________________________________________________________________

Review criteria:

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

All infants on high energy formula will need growth (weight and length) monitored to assess clinical effectiveness of the supplements.

Once catch up growth has been achieved, the high energy formula should be discontinued to prevent excessive weight gain.

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Pre-term infants

___________________________________________________________________

DIAGNOSIS: Infants born before 34 weeks gestation and weighing less than 2kg at birth are considered pre-term and may be discharged from hospital on a pre-term nutrient enriched post discharge formula.

TREATMENT SUMMARY: 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 nutrient enriched post discharge formula will be necessary.

Infant will have had their prescribed formula commenced on discharge from the Neonatal unit. It should not be initiated by primary care.

Pre-term formula is usually used for infants born before 34 weeks gestation, weighing less than 2kg at birth when breastmilk is not available.

These formulae should not be used in primary care to promote weight gain in patients other than infants born prematurely.

Infants will be discharged on liquid formula, transitioning to powdered formula after a month post discharge.

Initially a mother 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 on the advice of a member of the neonatal team including the paediatric dietitians.

Pre-term post discharge formula - guidance for choice of formula

Pre-term post discharge formula - do not initiate in primary care

Formula Age range Clinical guidance/notes

Nutriprem 2 powder (Cow & Gate)

Use up to 3-6 months

corrected age*

Dietary management of preterm and low birthweight infants post-discharge.

Nutriprem 2 liquid** (Cow & Gate)

Use up to 3-6 months

corrected age*

Dietary management of preterm and low birthweight infants post-discharge. After a month post discharge do not routinely prescribe liquid formulation.

SMA Gold Prem 2 powder (SMA Nutrition)

Use up to 3-6 months

corrected age*

Dietary management of preterm and low birthweight infants post-discharge.

SMA Gold Prem 2 liquid** (SMA Nutrition)

Use up to 3-6 months

corrected age*

Dietary management of preterm and low birthweight infants post-discharge. After a month post discharge do not routinely prescribe liquid formulation.

Corrected age: Corrected age is the actual age of the infant minus the number of weeks premature.

* Prescribable up to 6 months corrected age if indicated. ** On discharge from the Neonatal Unit, a short-term prescription will be requested for both liquid and powdered pre-term post discharge formula.

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Pre-term infants

___________________________________________________________________ REVIEW CRITERIA:

Infants should have their growth (weight, length and head circumference) monitored by their Health Visitor and/or community neonatal nurses whilst on these formulae.

All pre-term formulas should be stopped by 6 months corrected age and parents advised to start a standard infant formula.

Pre-term formula can be stopped before 6 months corrected age if there is excessive or rapid weight gain under the guidance of the paediatric dietitians.

For advice on pre-term infant weaning refer to the Bliss website find here. ONWARD REFERRAL:

These infants should already be under regular review by a Paediatrician. 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).

If there are concerns regarding growth at 6 months corrected age, or on return to standard formula refer to the paediatric dietitian.

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Author: Jane Stanger, Dietitian Approved: MKPAG July 2020 Review: Every 2 years

Infant formulary: Summary guidelines for the prescribing of specialist infant formula March 2020

Diagnosis Guidance Age range Formula Clinical indication Quantity for infant aged: Review criteria

< 6 months for 28 days

> 6 months for 28 days

Cow’s Milk Allergy (CMA)

(page 3-4)

First line Extensively Hydrolysed Formula

(EHF) to be used if mild to moderate Non-IgE or mild to

moderate IgE CMA suspected.

Birth to 1-2 years

Althera

(SMA) Lactose containing

Suspected or diagnosed CMA (Mild to moderate Non-IgE and mild to moderate IgE)

9 x 450g

6 x 450g

Infants prescribed any specialist infant formulae should be reviewed every 6 months.

Prescribe up to 2 years of age or until age-appropriate alternative milk is advised/infant tolerates cow’s milk. Infants with multiple allergies may require prescribed specialist infant formula up to 2 years of age.

Second line Extensively Hydrolysed Formula

(EHF) to be used if mild to moderate Non-IgE or mild to

moderate IgE CMA suspected.

Birth to 1-2 years

Alimentum

(Abbott Nutrition) Lactose free

Suspected or diagnosed CMA (Mild to moderate Non-IgE and mild to moderate IgE)

Use first line in infants with severe

diarrhoea/severe GI symptoms who would benefit from lactose free

formula.

10 x 400g

7 x 400g

Amino Acid based Formula (AAF)

Preferably started in secondary care for severe

Non-IgE mediated or severe IgE CMA.

May also be used in multiple

food allergies.

Birth to 2 years

First line Amino Acid based Formula (AAF)

Elecare

(Abbott Nutrition)

Other amino acid-based formulae may be initiated by secondary care including: Alfamino Nutramigen Puramino Neocate LCP Neocate Syneo

Use first line for severe Non-IgE mediated or severe IgE mediated

CMA.

Use if symptoms of CMA have not resolved on 2-4-week trial on EHF.

Do not use if extensively hydrolysed formula is not accepted simply based on taste; contact the dietetic team for

advice on alternative.

9 x 450g

6 x 450g

From 6 months

Neocate spoon

(Nutricia) CMA and multiple food allergies.

Amino acid-based powder that mixes

with water to form an unflavoured spoonable consistency suitable for

weaning.

Quantity to be advised following

assessment.

Quantity to be advised following

assessment.

Specialist milk over 1 year

Preferably started in secondary care for severe

Non-IgE mediated or severe IgE CMA.

May also be used in multiple

food allergies.

Over 1 year

Neocate junior

(Nutricia) Amino acid-based

formula

CMA, multiple food allergies and other indications where AAF is

recommended.

Quantity to be advised following

assessment.

Quantity to be advised following

assessment.

These products are only to be issued on

written request from a paediatric dietitian.

Nutramigen 3

(Mead Johnson) Extensively

hydrolysed formula

CMA, multiple food allergies and other indications where EHF is

recommended.

Quantity to be advised following

assessment.

Quantity to be advised following

assessment.

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Infant formulary: Summary of guidelines for the prescribing of specialist infant formula’s March 2020

Diagnosis Guidance Age range Formula Clinical indication Vol. < 6 months for

28 days

Vol.> 6 months for

28 days

Review criteria

Faltering growth

(page 9-10)

Specialist high energy formula. Only start in

secondary or specialist care.

From birth up to 12-18

months of age or 9kg body

weight

SMA High Energy

(SMA Nutrition) Similac High Energy

(Abbott Nutrition) Infatrini

(Nutricia)

High energy infant formula for infants with or at risk of faltering growth.

Quantity to be advised following

assessment.

Quantity to be advised following

assessment.

Review recent assessment report from paediatrician or paediatric dietitian.

Infatrini Peptisorb

(Nutricia) EHF

High energy extensively hydrolysed infant formula for infants with or at risk

of faltering growth/malabsorption.

Contains MCT.

Quantity to be advised following

assessment.

Quantity to be advised following

assessment.

Review recent assessment report from paediatrician or paediatric dietitian.

Pre-term

(page 11-12)

Specialist formula. Only start with guidance from

secondary care.

Birth to 3-6 months

corrected age

Nutriprem 2 powder

(Cow & Gate) Nutriprem 2 liquid**

(Cow & Gate) SMA Gold Prem 2

powder

(SMA Nutrition) SMA Gold Prem 2

liquid**

(SMA Nutrition)

Dietary management of preterm and low birthweight infants post-discharge.

Quantity to be advised following

assessment.

Quantity to be advised following

assessment.

On discharge from the Neonatal Unit, a short term prescription will be requested for both liquid and powder pre-term formulae. **After a month post discharge liquid pre-term formulae should not be prescribed.

Note: These guidelines are intended for use in primary care, if clinically indicated an alternative product may be requested by secondary or specialist care. The clinical rationale will be stated in

written correspondence.

KEY:

Initiated in primary care where possible.

Preferably started in secondary or specialist services. If started in primary care, refer to secondary care for assessment with paediatrician and/or specialist dietetic support.

Over the counter only - parents/carers need to purchase from supermarket/ local pharmacy/online.

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Infant formulary: Summary of guidelines for specialist infant formula TO BE PURCHASED BY PARENT/CARER

Diagnosis Guidance Age range Formula Clinical indication Considerations for use

Gastro-Oesophageal reflux Disease

(GORD)

(page 5-6)

Thickened formula.

To be used under medical supervision.

Birth to 1 year

Aptamil Anti-Reflux

(Cow & Gate) Cow & Gate Anti-

Reflux

(Nutricia) SMA Anti-Reflux

(SMA Nutrition) Enfamil AR

(Mead Johnson)

GOR/GORD Advise parents to make feeds according to manufacturer’s instructions - preparation differs between brands.

Thickened formula may require the use of a large hole (fast flow) teat.

Pre-thickened formula should not be used along with other thickening agents.

Formula’s that thicken in the stomach react with stomach acids to thicken and should not be used in conjunction with separate thickeners or with medication such a ranitidine, or proton pump inhibitors.

Lactose intolerance

(page 7-8)

To be used under medical supervision.

Birth to 1 year SMA LF Lactose free

(SMA) Enfamil O-Lac with

LIPIL

(Mead Johnson) Aptamil Lactose free

(Nutricia)

Lactose intolerance Not suitable for infants with suspected cow’s milk allergy.

Should only be used for a maximum of 6-8 weeks after which infant should be challenged with a standard cow’s milk based infant formula.

After 1 year can use shop bought full fat lactose free milk.

Cow’s milk allergy

(CMA)

(page 3-4)

To be used under medical supervision.

6 months - 1 year

SMA Wysoy

(SMA Nutrition) Soya formula Soya formula should only be used after 6 months of age

if the first line extensively hydrolysed formula is not accepted due to taste.

Unsuitable for infants who have reacted to soya traces in food.

Note: These guidelines are intended for use in primary care, if clinically indicated an alternative product may be requested by secondary or specialist care. The clinical rationale will be stated in

written correspondence.

KEY:

Initiated in primary care where possible.

Preferably started in secondary or specialist services. If started in primary care, refer to secondary care for assessment with paediatrician and/or specialist dietetic support.

Over the counter only - parents/carers need to purchase from supermarket/local pharmacy/online.

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Author: Jane Stanger, Dietitian Approved: MKPAG July 2020 Review: Every 2 years

Acknowledgements:

Milton Keynes Clinical Commissioning Group

Pharmaceutical Advisers

Paediatric Dietetic Team Milton Keynes University Hospital

Luton and Bedfordshire Paediatric Dietetic Services

Dr Jyothi Srinivas, Consultant Paediatrician, Milton Keynes University Hospital

Useful sources of information:

British Dietetic Association (BDA) - Food fact sheets including information on following a cow’s milk free diet.

www.bda.uk.com

Bliss - website for parents of babies born premature or sick; includes information on weaning your premature infant.

https://www.bliss.org.uk/parents/about-your-baby/feeding/weaning-your-premature-baby

Infant milks in the UK: A Practical Guide for Health Professionals - January 2020. Authors: Dr Helen Crawley and Susan Westland. FIRST STEPS NUTRITION TRUST.

www.firststepsnutrition.org

The GP Infant Feeding Network (UK) - website to assist primary care practitioners with best practice in infant feeding.

www.gpifn.org.uk

The Milk Allergy in Primary Care (MAP) guideline 2019

https://gpifn.org.uk/imap/

References: Fox, A et al (2019) ‘An update to the Milk Allergy in Primary Care guideline’ Clinical and Transitional Allergy. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6689885/ Luyt, D et al. BSACI guideline for the diagnosis and management of cow’s milk allergy. Clinical and Experimental Allergy 2014; 44: 642-672 National Institute for Health & Care Excellence (2015) Clinical Guideline 1: Gastro-oesophageal reflux disease in children and young people: diagnosis and management (NG1). Available at: http://www.nice.org.uk/guidance/ng1 National Institute for Health & Care Excellence (2017) Clinical guideline 75: Faltering growth: recognition and management of faltering growth in children. Available at: http://www.nice.org.uk/guidance/ng75 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

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people in primary care and community settings. Available at: http://www.nice.org.uk/guidance/cg116/chapter/1-Guidance PrescQIPP Bulletin 146 (November 2016) 2.1, Appropriate prescribing of specialist infant formulae (foods for special medical purposes). Available at: https://www.prescqipp.info/infant-feeds/category/93-infant-feeds

Royal College of Paediatrics and Child Health (RCPCH) Growth charts. Available at: https://www.rcpch.ac.uk/resources/growth-charts Venter, C 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. Available at: http://www.ctajournal.com/content/pdf/2045-7022-3-23.pdf

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Appendix 1:

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.

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/